Post Job

Lundbeck Jobs

- 23,142 Jobs
  • Director Regulatory Affairs Alliance and Commercialization - Remote Opportunity

    Lundbeck LLC 4.9company rating

    Lundbeck LLC Job In Deerfield, IL Or Remote

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote opportunitiy - Open to candidates anywhere in the greater United States SUMMARY: The Director, US Regulatory Affairs Alliance and Commercialization, will oversee and lead regulatory affairs strategy for our alliance partnership products and commercialization efforts, requiring knowledge and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy. This role will lead regulatory efforts for the successful development, approval, and lifecycle management of drug and biological alliance and Lundbeck products for the US and global markets, as well as providing support to the Lundbeck development portfolio. The Director will enable cross-functional team delivery, provide strategic regulatory guidance, and ensure compliance with applicable regulations and internal policies. In total, we are looking for someone with a broad regulatory background spanning the entire product value chain. ESSENTIAL FUNCTIONS: * Primary US regulatory point-of-contact for alliance product brands, as assigned, including managing cross-functional and multi-level governance and alignment meetings, including regulatory strategy, promotion, and labelling considerations. * Ensure commercial enabling strategic partnership with alliance partners to accelerate brand success and foster Lundbeck connectivity into the alliance team matrix. * Collaborate as the US regulatory alliance product leader with global and other key stakeholders, influencing cross-functional partnership development teams and governance decisions. * Oversee the assembly and creation of documentation to support investigational and marketing registration packages for the US FDA. * Partner with alliance regulatory colleagues regarding submission activities, including, approval, and post-approval activities. * Provide regulatory strategic guidance and identify requirements for clinical studies, marketing approval, product labelling and external scientific communication and Promotional activities. * Lead regulatory engagement activities, including strategic, promotional, scientific, and labelling efforts, and provide regulatory guidance and promotional compliance directions for alliance portfolio and external communication materials, medical and scientific messaging, sales and marketing training, sample management, and product campaigns. * Ensure compliance with US regulations, MLR processes, and internal policies on external communications, advertising, and promotion. * Provide regulatory guidance on external corporate communications, patient advocacy, medical publications, and trial engagement materials. * Provide directions to global labeling processes, including inform decisions on Target Product Label enabling optimal commercialization strategy. * Support launch planning activities, including timeline development, strategic review of launch materials, and provide integrated communication. REQUIRED EDUCATION, EXPERIENCE AND SKILLS: * Accredited bachelor's degree. * 10+ years R&D experience within a pharmaceutical, medical device, and/or biotech industry. * 5+ years' experience in Regulatory Affairs. * Experience developing and maintaining alliance partnerships in regulatory activities within the US. * Strong knowledge of US regulatory requirements and processes including understanding of regulatory interdependencies such as strategy, scientific messaging, promotional compliance and FDA labeling. * Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams. * Demonstrated alliance strategy leadership and motivation to successfully execute on regulatory strategies. * Knowledge of development and registration timelines and requirements, to enable process management and compliance. * Agile minded, seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective. * Ability to influence division management at all levels to support regulatory compliance needs. * Highly proficient in communicating strategic and tactical issues to alliance partners and management. * Effectively able to multi-task within assigned deadlines. * Excellent communication and interpersonal skills. * Excellent written and oral communication skills. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: * Accredited Bachelor's Degree in life sciences. * Masters. Doctorate Degree or MBA, other professional certifications. * FDA interaction experience. * Exposure to international regulatory affairs, including participation in submissions to ex-US authorities. * Experience in global process improvement efforts. * Experience in labelling regulations and label development management. * Understanding of US promotional requirements with experience in regulatory advertisement and promotional review. TRAVEL: * Ability to travel up to 20% international travel may be required. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $190,000 - $225,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. #LI-BK1 Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.
    $190k-225k yearly 5d ago
  • Director KOL and Peer-to-Peer Programs - Remote

    Lundbeck LLC 4.9company rating

    Lundbeck LLC Job In Deerfield, IL Or Remote

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote opportunitiy - Open to candidates anywhere in the greater United States SUMMARY The Director, KOL Strategy and Peer-to-Peer Programs will be responsible for developing KOL relationships, managing and executing our promotional medical education (PME), and key medical meetings & congresses/conventions. Through collaboration with an alliance partner, he/she will contribute to the development of key professional marketing strategies, drive brand execution and performance as a leader across all professional marketing work streams within the team, in collaboration with cross-functional partners, and through individual projects. This individual proactively engages cross-functional stakeholders in Medical, Sales, and Finance. RESPONSIBILITIES * Develop and grow strategic relationships with key KOLs to understand and monitor REXULTI & competitor perceptions, market developments & trends, and opportunities to improve REXULTI and related disease state education * Leads development and implementation of PME promotional materials to continue brand growth * Leads speaker bureau creation and management for existing and new indications * Lead development and implementation of commercial congress strategy and symposia execution * Support the design and development of professional advisory boards as needed to obtain feedback from external experts * Serve as Commercial liaison to Medical, with a deep understanding of key projects, developments, presentations, and initiatives * Maintain a comprehensive, dynamic, and ongoing understanding of the disease state, competitive landscape and therapeutic management, and market dynamics of the neuroscience space * Generate insight-driven recommendations using various inputs (market research, KOL discussions, advisory boards), to create hypotheses and evaluate opportunities for evolution of the REXULTI-related education strategy for the US * Provide active input into the development and review of brand strategy, tactical plans and the financial plan * Coordinate and lead Commercial KOL interactions at congresses, collaborating across key cross-functional partners as appropriate and leadership * Execute multiple, simultaneous projects and manage resources to ensure deliverables are on time, on budget, and answer business objectives * Functions as primary brand team liaison for sales related to PME-related issues * Manage budget, allocating funds based on brand goals and objectives * Leads KOL interactions at commercial meetings, including sourcing, contracting, and facilitating * Assist with providing Commercial recommendations for scientific data generation needs for REXULTI for Medical team consideration as appropriate * Collaborates with key functions as appropriate including Medical Affairs, PME Marketing, HCP Marketing, Sales Leadership, and Patient Advocacy REQUIRED EDUCATION, EXPERIENCE and SKILLS: * Bachelor's Degree from an accredited institution * Minimum of 10 years of Commercial or Medical experience (e.g., Sales, Marketing, Market Access, Medical Affairs, Field Medical, HEOR, and/or Sales Operations) * 6+ years of experience in the pharmaceutical, biotech, medical device, and/or healthcare industries * Experience interpreting clinical trial endpoints and translating them into commercially relevant messaging * Proven ability to understand the underlying science of disease states and medications, and utilize that knowledge to engage in meaningful conversations with KOLs (Key Opinion Leaders) * Strong interpersonal skills with a demonstrated ability to effectively collaborate within internal and external networks in a fast-paced, high-energy environment * Operational expertise with a proven ability to lead large, complex projects and ensure timely delivery * Track record of success in strategic thinking, driving behavior changes, problem-solving, and decision-making, particularly in ambiguous situations and agile working environments * Experience in relationship development and the ability to work effectively both independently and as a cross-functional team leader * Proficiency in Microsoft Office tools, including Word, Excel, and PowerPoint PREFERRED EDUCATION, EXPERIENCE AND SKILLS: * MBA or master's degree (preferably science focused) * Experience in Psychiatry and/or Neurology disease states * Experience with focus on US professional marketing, professional relations and thought leader engagement * Launch experience * Knowledge of the AMA, ACCME, PhRMA and FDA regulations associated with promotion and industry-supported scientific education activities * Pharmaceutical sales or Medical Science Liaison (MSL) experience TRAVEL * Willingness/Ability to travel approximately 50-75% domestically. International travel may be required. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $225,000 - $260,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis. #LI-GK1 Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real. About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. The brain health challenge is real. Our commitment is real. Our impact is real.
    $63k-107k yearly est. 12d ago
  • Production Technician

    Sanofi 4.3company rating

    Pennsylvania Job

    Job title: Production Technician- Vaccines About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Swiftwater site is in northeast Pennsylvania and is home to the production of over 120 million doses of injectables that help prevent diseases and enhance patients' quality of life. Our teams follow current Good Manufacturing Practices (cGMP) and procedures while working in a fast-paced team environment. All levels of production technicians represent the “heartbeat” of the manufacturing facilities and are responsible for the high quality and efficient production of our injectables in accordance with current good manufacturing practices (cGMP) for all relevant regulatory agencies (e.g. FDA). Positions within production facilities may change based off of business needs and seasonality. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world. Main Responsibilities: Requires 20/20 vision with corrective lenses and yearly eye exam Bench lead, cap check, and stopper checks Ensures the completion of sampling and corresponding documentation as required. Ensures the completion of move tickets to ensure accurate inventory. Operating automated visual inspection equipment Focus on quality and safety of teammates, processes, products, equipment, and documentation Ability to work in both an individual and team environment Is trained according to all training assignments Your individual contributions will drive collective business goals which ultimately help patients Completes tasks and corresponding documentation as required by cGMP Ability to lift between 1 to 50 pounds per health center Regulatory audit understanding and awareness About You You are professional, detail-oriented, coachable, and a trainable person who thrives in a fast-paced team environment. Experience: 6+ months of prior manufacturing/warehouse work experience and/or college degree. Work experience may be used in lieu of college degree. Veterans who served in the US military on active duty and/or National Guard member who have receive honorable or general discharge and/or medical discharge. Soft skills: Cooperates willingly with colleagues, establishes rapport in a friendly and courteous manner. Maintains positive working relationships and is willing to help others. Technical skills: Basic computer skills and previous production experience preferred. Education: High school diploma or GED required, associate degree or bachelor's degree preferred. Languages: Reading, writing, comprehension, communication in English is preferred, but all multi-lingual languages welcomed. Special Requirements: Product specific vaccination is required. Able to receive influenza vaccine, required for building access. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $34k-46k yearly est. 29d ago
  • Head, Health Value Translation Rare Disease, Rare Blood, Neuro

    Sanofi 4.3company rating

    Cambridge, MA Job

    Job Title: Head, Health Value Translation Rare Disease, Rare Blood, Neuro About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. As a member of the PID&HVT leadership, this position is responsible for the direction and management of a team of Health Value Translation Leads (HVT Leads) representing the department at the Global Project Team and leading the delivery of the cross-functional Patient Disease Strategy for indications under therapeutic alignment. This is a leadership-strategic and highly cross functional role in the transformation of Sanofi development towards BiC patient-centric development evidenced by delivering impactful and differentiating value propositions at launch and across life cycle. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: HVT Leads establish and execute, with collaboration from cross functional counterparts, the Patient Disease Strategy (PDS) starting in M2 through to phase 3 development programs for all assets. Budgeting and resource management aligned to pipeline and PDS implications supporting the pipeline/ development staged programs HVT Leads are effectively developing, coordinating and integrating the PDS based on the inputs from the broader department, considering the translation of patient relevant experience, priorities and unmet need to bring forward high impact strategies related to R&D pipeline/ asset differentiation, acceleration, awareness and access. Awareness and access are related to the science, clinical trials and creating advocacy ahead of the asset being a future marketed product HVT leads aptly integrate COA sciences into GPT subteams thereby enabling differentiated positioning of each asset relative to competition, standards of care and emerging trends in the regulatory and payer environments The department’s contribution to BiC patient-informed Target Value Proposition (TVP), Target Product Profiles (TPP) and Target Product Label (TPL) linked to associated evidence generation, notably a differentiated COA strategy. Main point of contact for Global Project Heads on matters relevant to TA level pipeline strategy, HVT performance and departmental impact Effective and results driven connectivity with leadership across Medical, Patient Safety & Pharmacovigilance, Market Access, New Product Planning, Global Regulatory to align the PDS for BiC drug development and risk mitigation for post Phase 3 product launch Contribute to research priorities (pre-M2) through patients’ disease experience and unmet needs insights to impact pipeline prioritization and early signal seeking of experience. As needed, anticipate, coordinate and execute on patient preference modelling and studies. Health Value Translation role has expert capabilities and expertise in: Patient disease strategy frameworks, gap analysis assessments, risk mitigation and solutions that address both Global and Local country needs Ability to devise and implement, in collaboration with other stakeholders, a robust Patient Engagement Strategy linked to the deliverables of the PDS. Work closely with the Patient Engagement Leads to create strategic plans that deliver on mutually beneficial partnership with advocacy KOLs to shape pre-clinical Research and Development staged decision making while also capitalizing on local country opportunities to accelerate programs by improving patient connectivity to clinical trials Evolving digital capabilities that support speed in decision making, improve predictive analytic capabilities and enhance data collection methods in clinical trials (eg collaborate with Digital Biomarker team) The ability to drive to consensus building across various functional perspectives Development of patient informed TVP/TPP/TPL in collaboration with GPT functions to incorporate new data sources and methods (eg: Patient preferences, patient generated health data, digital innovation...) to identify meaningful clinical outcomes & tolerability, sub-populations at the highest unmet needs and drug delivery and care experience preferences. Thought leadership representing PID&HVT internally and externally (publications, congresses, conferences, etc) Represent department in relevant governance meetings (eg, TA aligned DWG) About You Requirements Advanced degree in health sciences with at least 15 years of experience in drug development Strong digital expertise, including novel methods of modeling and simulation, predictive analytics, population health management , digital health Demonstrated thought leadership in patient integrated drug development Ability to lead, and influence, high performance teams Robust drug development background across the life cycle with experience in supporting pre- launch excellence and post approval access drivers. Preferred, but not required, experience with interactions with regulators and payers. Experience with evidence generation beyond RCT: eg, integration and use of RWE for differentiation and benefit assessments, modeling and simulation, etc Knowledge of global public health systems, emerging challenges, patient driven decision-making drivers, market access pharma R&D, commercial. Skills Leadership both Strategic and Hands on (implementation) Strategic: Analytics and problem-solving skills “Think strategically” Simplification of complex problems and trade off discussions, innovative Team spirit, trustful partner Performance orientation “Strive for results” Collaborative approach “Cooperate transversally” Ability to listen and understand different point of views and to influencez Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Hybrid #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $68k-112k yearly est. 16d ago
  • Global Head of AI-Driven Innovations in Clinical Data & AI Processing

    Sanofi 4.3company rating

    Cambridge, MA Job

    Job Title: Global Head of AI-Driven Innovations, Clinical Data and AI Processing About the job At Sanofi, we chase the miracles of science to improve people's lives. We are accelerating Sanofi's modernization journey, supporting our Play to Win strategy to become more focused, integrated, agile, and efficient. The current wave of digital technologies in artificial intelligence (AI) and Generative AI offers enormous opportunities to transform clinical development. To harness the power of new technologies and accelerate digital transformation, we created a new Clinical Data & AI Processing (CDAIP) department within Clinical Sciences and Operations. The Global Head of AI-Driven Innovations in CDAIP will drive the strategy to apply artificial intelligence and cutting-edge innovations to transform clinical data processing and analytics, enhancing drug development processes and patient outcomes. Main responsibilities include: Strategic Leadership: develop and lead a comprehensive strategy for leveraging AI and advanced data processing in clinical development; enable real-time, interactive access to clinical data and analytics with AI-powered processes Innovation Driver: identify emerging technologies and methodologies in AI and data science that can be applied to clinical data processing; spearhead the development and implementation of innovative AI and end-end data processing & solutions for clinical data analysis; manage complex, multi-disciplinary projects that leverage AI and advanced data processing in clinical development and change management Team Leadership: build, lead, and mentor a high-performing team of Innovation Project Leaders, Business Analysts, and Experts in Clinical Data & Analytics; promote a collaborative work environment that encourages creativity and problem-solving; foster a culture of innovation, continuous learning, and excellence within the team and ensure CDAIP and CSO stay at the forefront of industry advancements Stakeholder Management: collaborate with senior leadership to align department goals with overall company strategy; partner with clinical and Digital teams to ensure seamless integration of AI and data processing solutions into existing workflows Compliance and Ethics: ensure all AI and data processing activities comply with relevant regulations and ethical standards; develop and maintain robust data governance and security protocols related to AI; stay informed about evolving regulations and industry standards related to AI in healthcare 3. About you Advanced degree in biostatistics, statistics, Data Science, Bioinformatics, or a related field Extensive experience in clinical operations with insight in data management, and biometrics Understanding of machine learning, natural language processing, and other relevant AI technologies Strong understanding of clinical development processes and regulatory requirements 10+ years of experience in leadership roles within clinical data processing and/or analytics, AI, or related fields in the pharmaceutical or healthcare industry Proven track record of leadership and accomplishment in implementing AI and advanced data processing solutions in clinical operations Visionary mindset with a passion for driving innovation in healthcare Excellent leadership, communication, and interpersonal skills; ability to translate complex technical concepts to non-technical stakeholders 4. Pursue Progress, discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Hybrid #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $101k-130k yearly est. 10d ago
  • Global Therapeutic Area Head, Dermatology, Immunology

    Sanofi 4.3company rating

    Cambridge, MA Job

    Job Title: Global Therapeutic Area Head, Dermatology, Immunology About the Job Reporting to the Global Head of Immunology and as a member of the Immunology Franchise Leadership Team (IFLT), lead the Global Dermatology Immunology TA, with responsibility to take assets from PoCC to Wave 1 launches. Key Assets: Amlitelimab, Rilzabrutnib, Lunsekimig, Brivekimig Disease Areas: AD, HS, CSU, PN, AA, Vitiligo We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world. Main Responsibilities: Develop Disease Area strategy and co-positioning narrative of multiple assets in the same disease area that maximizes value for Sanofi. Oversee market development / shaping strategy, pre-launch and launch plans for assets with partnership of Wave 1 countries and Global Brand Teams Direct the institutional learning and market shaping around an asset or in a new disease area by commissioning rapid and appropriate insights work, connecting with KOLs and patient advocacy groups and leaders Working with SILC LEx, create the preparedness required for a successful launch by ensuring rigorous launch readiness management, lead effective launch readiness reviews with senior management updating them on progress, and being vocal about barriers and opportunities Own Global P&L and oversee strategic and financial planning for brands, developing sales and expense forecasts to maximize value Lead vision & strategy development for launch brands and provide strategic leadership to Global Brand Teams (GBT) for Amlitelimab, Lunsekimig and Rilzabrutnib covering value & access, patient advocacy, medical, and commercial activities in collaboration with US and key markets for the brands Following the successful launch in Wave 1 markets, mobilize TA BLs/IBLs and GBTs to continue supporting Wave 2+ country launches Actively partner with global project teams and NPP teams to provide robust commercial direction on pipeline planning and product development strategy Support the program teams directly and/or through the NPP team throughout the governance process (TARC, DWG, IDCC) providing TA business leadership within the franchise, R&D and investment committees. Understand and communicate requirements for regulatory approval (registration), access to market (pricing & reimbursement), and market differentiation required for the successful commercialization of new products. Partner with NPP, business development and related M&A teams to ensure the BD roadmap remains in-line with TA strategy and evaluate potential commercial synergies with TA portfolio. Build and develop a best-in-class team, and foster strong coordination across functions About You Experience & Qualifications: A minimum of a Bachelor’s Degree is required. MBA, MS or PhD in life science is preferred Extensive and diverse industry experience: A minimum of 10 years of experience in the pharmaceutical industry, across various functions (e.g., sales, marketing, MA, BD, NPP, etc.), including in US/key markets, with a focus on Dermatology Immunology and related therapeutic areas (e.g., in-depth knowledge of key stakeholders / influencers / competitors is required Leadership and brand management: experience in leading teams and brand/portfolio strategies in US/key markets (e.g., Franchise Head, GM) is required Current or prior experience managing global brands is preferred Launch and pre-launch experience: strong track record in successfully launching and pre-launching products in US/key markets is required Strong credibility in P&L management Cross-functional enterprise leadership and strong capacity to drive decision-making with key internal stakeholders is require Stakeholder engagement: ability to advocate for Sanofi’s vision, and negotiate and drive value from key partnerships, such as alliances, analysts and the investment community, patient organizations, and scientific institutions is required) Demonstrated ability to work collaboratively in a matrixed environment with many cross-functional partners including marketing brand teams, market research, market access, medical affairs, business development, regulatory, research & development, manufacturing, finance and legal Ability to work in a fast-paced environment and quickly adjust to changing priorities is essential Excellent interpersonal, oral and written communication skills, including ability to synthesize and deliver a clear overview of the strategy, opportunity and risks for Sanofi executives This position may require up to 25% overall travel Valid passport and ability to travel internationally Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Hybrid #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $224k-368k yearly est. 7d ago
  • Manager, Biologics Continuous Improvement - Vaccines

    Sanofi 4.3company rating

    Pennsylvania Job

    Job Title: Manager, Biologics Continuous Improvement - Vaccines About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. This position takes a leadership role in identifying and resolving issues related to manufacturing process equipment and/or automated control systems for Continuous Improvement projects for safety, compliance, delivery, and efficiency that impact the supply of bulk Biologic vaccine products. This position drives continuous improvement by leading cross-functional teams to support Biologics Manufacturing to ensure the manufacturing process equipment operates as expected. Develop and execute or assist in the execution of commissioning and qualification documentation. This position requires a high degree of relationship building and communication with operations, engineering, automation, maintenance, quality validation and quality assurance. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing Progress to make a real impact on millions of patients around the world. Main Responsibilities: Responsibilities include project scope related to manufacturing process equipment, automated control systems, change control development and execution, commissioning and qualification documentation development and execution, test script and protocol completion activities. Collaborate with Automation, Engineering and Maintenance to represent the factory with internal and external suppliers and customers for projects related to automated control systems within Continuous Improvement. Become a Subject Matter Expert (SME) on the state of the industry trends for automated control systems. Through continuing education, remain current with industry knowledge, trends, and best practices. As a SME, provide strategic input required to stay competitive in the bulk vaccine manufacturing market. Attend L1 +QDCI board meetings to gather and report out on issues / opportunities existing on the shop floor. Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees. CONTEXT OF THE JOB/MAJOR CHALLENGES The Manager, Continuous Improvement will identify, investigate, troubleshoot, and resolve issues that impact the manufacturing process equipment and/or automated control systems including but not limited to Wonderware and Delta V. The Manager, Continuous Improvement is tasked with leading change. This position is responsible for collaborating with Operations and is expected to work effectively with other supporting functions such as Quality, Engineering, Automation, Maintenance and Manufacturing Technology. The Manager, Continuous Improvement will provide operational and technical input to the Antigen Continuous Improvement Team by direct participation and integration into factory operations. This is accomplished through a high degree of shop floor presence and participation in the focus factory. The Manager, Continuous Improvement will serve as the subject matter expert (SME) within the Antigen Continuous Improvement Team for projects related to manufacturing process equipment, PLC programming, HMI development and technical interface with automated control systems. About You EDUCATION/EXPERIENCE BS or MS in a field related to Engineering, Chemical or Mechanical preferred. The individual should have at least 5+ years’ experience in a biotech or pharmaceutical role within the areas of manufacturing, engineering, automation, process development or similar. The individual must have an excellent understanding of cGMP requirements and Continuous Improvement methodologies, along with demonstrated excellence in a technical or scientific position. Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively lead cross-functional teams. Certifications Wonderware, Delta V, Lean Manufacturing, Six-Sigma, and similar certifications are a plus. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $88k-116k yearly est. 12d ago
  • Automation Project Leader

    Sanofi 4.3company rating

    Pennsylvania Job

    Job Title: Automation Project Leader About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. You will be part of Sanofi Global Engineering's Manufacturing Systems & Automation department, embedded within project teams for the delivery of Major Investment projects for Sanofi Americas region. This pivotal role offers a unique opportunity to influence the global manufacturing strategy through innovative solutions. You'll work with a dynamic team to integrate and advance state-of-the-art manufacturing systems and automation, ensuring Sanofi remains at the forefront of the industry. As an Automation Project Leader within our Global Manufacturing Systems & Automation team, you’ll drive innovation by integrating and advancing cutting-edge manufacturing solutions, significantly influencing our global manufacturing strategy and supporting the Global project teams. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Develop and implement a comprehensive strategy for manufacturing systems and automation within the project team, ensuring alignment with safety, quality, business, and user requirements. Create detailed project plans outlining schedules, resource allocation, milestones, and deliverables for the automation and manufacturing systems scope. Lead the project automation team in the design and development of control systems for manufacturing processes and facilities, ensuring accurate installation and compliance with safety, quality and sustainability objectives. Integrate automation systems with digital applications, ensuring seamless connectivity between production, quality control, and data management. Coordinate with procurement and project teams to select vendors, ensuring their solutions meet quality and regulatory standards. Ensure consistency in automation design and execution between all Sanofi facilities, adhering to a uniform approach. Identify and manage risks proactively, ensuring compliance with GMP and minimizing disruptions to project timelines and costs. About You Experience: Proven track record in managing complex manufacturing systems involving automation, robotics, and advanced technologies, in the pharmaceutical sector. Technical Skills: Proficiency in Process Control Systems (DeltaV), SCADA (Ignition), PLCs (Rockwell), and other automation technologies (Data Historian, Building Management Systems (BMS) and Manufacturing Execution Systems (MES), with the ability to design and implement robust system integration architectures. Education: A degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or a related field. Soft Skills: Strong analytical and problem-solving skills, effective communication with stakeholders, and leadership and collaboration abilities with cross-functional teams. Languages: Proficiency in English is essential; additional language skills are a plus. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $89k-126k yearly est. 13d ago
  • Manager, Research Fulfillment and Projects

    Universal Orlando 4.0company rating

    Orlando, FL Job

    Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybrid capacity, contributing from the workplace a minimum of three days per week. There are also roles that require being on-site full time. Limited remote opportunities may be available within specific departments. You’ll learn more about this during the recruitment process. JOB SUMMARY: The Manager, Research Fulfillment & Projects, is responsible for leading a team that executes critical research operations processes, ensuring high-quality data collection, reporting, and work stream efficiency. This role oversees project intake and distribution, manages team workloads, ensures accuracy and adherence to timelines, and drives process improvements in survey programming, sample deployment, data processing, and reporting. The ideal candidate has a strong background in research operations oversight, thrives in a fast-paced environment, and is adept at prioritizing and streamlining multiple simultaneous requests. MAJOR RESPONSIBILITIES: Team & Workflow Management Oversee a team of direct reports, assigning incoming requests and balancing workloads to ensure efficient execution. Enforce team accountability to deadlines, quality standards, and process adherence. Monitor individual and team performance in speed, efficiency, accuracy, and complexity of assigned tasks. Embrace and imbue team values of accuracy, efficiency, reliability, seamlessness, service, and technical mastery. Operational Oversight & Quality Assurance Conduct high-level reviews of team outputs to ensure accuracy and adherence to best practices. Identify workflow inefficiencies and implement improvements in project intake, task execution, and cross-team collaboration. Work with senior team members to ensure effective knowledge sharing and technical upskilling across the team. Stakeholder & Cross-Functional Liaison Act as the primary liaison with the Research Insights team, managing intake and communication to ensure seamless service. Collaborate with the Data Integration & Dev teams to optimize processes and drive automation where possible. Provide input on the refinement of standardized templates and research processes based on operational feedback. Training & Development Facilitate ongoing training by coordinating knowledge-sharing sessions from senior specialists and technical experts. Support junior staff in developing their expertise in research tools and quality assurance. Process Innovation & Tool Optimization Lead initiatives to enhance operational efficiencies, leveraging project management tools and workflow optimizations. Advise and implement new methodologies or software that improve team output and accuracy. Understand and actively participate in Environmental, Health & Safety responsibilities by following established UDX policy, procedures, training, and team member involvement activities. Perform other duties as assigned. EDUCATION: Bachelor’s degree in business, marketing, market research, analytics, data management, or a related field. Certifications in PMP, Market Research Project Management is a plus. EXPERIENCE: 5+ years of experience leading teams in an operational oversight role (e.g., Operations Manager, Traffic/Production Manager, or Analytics Project Manager, etc.) is required. Experience in consumer research, marketing, business analytics, data management, or a related field is preferred. Candidates with equivalent combination of education and experience will be considered. ADDITIONAL INFORMATION: Proven ability to manage high-volume, fast-paced workflow operations with strong organizational skills. Strong leadership skills with experience mentoring, developing, and managing teams. Exceptional attention to detail and experience reinforcing quality control processes. Ability to coordinate and communicate effectively across teams. At minimum, a notional understanding of survey programming, data processing, general research workflows and common tools / platforms (e.g., Qualtrics, DisplayR, SPSS, Excel, PowerPoint). Familiarity with interpreting data in a business context, statistics fundamentals. Your talent, skills and experience will be rewarded with a competitive compensation package. Universal is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Universal Orlando via-email, the Internet or in any form and/or method without a valid written Statement of Work in place for this position from Universal Orlando HR/Recruitment will be deemed the sole property of Universal Orlando. No fee will be paid in the event the candidate is hired by Universal Orlando as a result of the referral or through other means. Universal Orlando Resort. Here you can. Universal Orlando is an equal opportunity employer. Universal elements and all related indicia TM & © 2025 Universal Studios. All rights reserved. EOE
    $56k-68k yearly est. 22d ago
  • Paramedic or LPN, LVN or Advanced EMT

    CSL Plasma 4.6company rating

    Saint Paul, MN Job

    The Opportunity Responsible for the evaluation of donor suitability for automated pheresis procedures. Administration and supervision of approved immunizations other than red blood cell immunizations. Provides limited emergency medical care to donors and staff, including the administration of medication or treatments in accordance with licensure or certification. You will report to the Center Manager. The Role Promotes positive customer relations with all donors. Conducts confidential and effective interviews with donors to obtain necessary information regarding suitability to donate plasma. In conjunction with the Center Medical Director and/or Center Physician responds to medically related questions from staff including donor suitability and provides information to staff on medically related issues. Performs medical history reviews and health assessments on donors. Assesses results of donor screening and laboratory tests to determine initial and continuing donor suitability. Notifies and counsels donors regarding reactive test results. Refers donors to community facilities for follow-up and counseling. Explains informed consent to applicant donors. This includes explanation of procedures, hazards and potential adverse events; explanation of immunization schedules, dose and antibody response; providing clear opportunity for donor to refuse participation; obtaining signature and date certifying informed consent. Handles medical emergencies at the Center by providing routine care as outlined in Standard Operating Procedures (SOPs); elevates situations to Center Physician or local medical service providers as required. Periodically checks emergency kits to assure supplies are present and in-date. Reviews test results and determines continued donor suitability. Follows SOPs regarding acceptable ranges of four-month required test (PE/STS) reports. Maintains knowledge of and apply all rules regarding four-month approvals and grace periods. Assess signs and symptoms a donor may exhibit that may result in the inability to continue donating. Understands the policies and procedures associated with hyper immune programs at the center where applicable, and oversees donor immunization programs. Reviews antibody titer results as required. Maintains awareness of appropriate immunization schedule for each antigen. Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. Maintains clean efficient work environment, and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. May conduct routine audits of these internal procedures and documentation. Maintains confidentiality of all personnel, donor and center information. May be cross-trained in other areas to meet the needs of the business. Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. Perform other job-related duties as assigned. Your skills and experience Education Graduation from a paramedic, nursing, physician assistant, chiropractic, medical school or naturopathic medical training program If graduation is from a foreign allopathic or osteopathic medical school, must also currently be licensed as a physician or state certification as an emergency medical technician Experience Minimum of one (1) year experience in a health care environment Experience in a plasma or whole blood collection center or other regulated environment preferred Ability to make and analyze a physical assessment of heart, lung sounds, signs of drug use, etc. Ability to instruct donors, staff and community regarding the benefit of plasma donation programs Working Conditions (physical & mental requirements) Ability to make decisions, which have moderate impact on immediate work unit. Ability to understand, remember and apply oral and/or written instructions Must be able to see and speak with customers and observe equipment operation Occasionally perform tasks while standing and walking up to 100% of time Examine and assess the skin and other abnormalities through sight, touch and smell Reach, bend, kneel and have high level of manual dexterity Occasionally be required to lift and carry up to 25 pounds Fast paced environment with frequent interruptions Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens Required to wear Personal Protective Equipment while performing specific tasks or in certain areas Required to work overtime and extended hours to support center operational needs #ZR Our Benefits CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit ***************************** About CSLPlasma CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL. Do work that matters at CSL Plasma!
    $43k-62k yearly est. 9d ago
  • Senior Clinical Research Director, Ophthalmology

    Sanofi 4.3company rating

    Cambridge, MA Job

    Job Title: Senior Clinical Research Director, Ophthalmology About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Senior Clinical Research Director (CRD) is an expert clinical lead for one or several indications in the Development of an R&D program and is responsible for leading clinical team(s) to deliver successful clinical trials for novel therapeutics for Ophthalmologic Diseases. The role requires clinical leadership, organization skills, strategically and operationally focused, resourceful individual with capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks. We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: The role of the Senior CRD is to: Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs Establish clinical development strategy and lead clinical team, collaborate with other medical and clinical scientific experts, clinical development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment) Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities. Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, has the capacity to train them on the medical/scientific strategy by indication Scientific and Technical Expertise: Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders Key responsibilities: Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available Leads the clinical development including planned life cycle management (LCM) Ongoing assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team Implements strategies to identify, monitor and resolve clinical program/trial issues. Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data. Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provides clinical input to Statistical Analysis Plans (SAP), Target Product Profile (TPP) and Risk Management Plan Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project Lead the medical/clinical assessment of license-in opportunities, as needed Manage other study physicians (CRDs) and clinical scientists in the same program, as needed Author or co-author manuscripts and abstracts Establishes and maintains appropriate collaborations with key opinion leaders or advisory boards Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering committees, benefit-risk assessment committee, and at the submission task force. About You Basic Qualifications: Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred More than 7 years of clinical trial and/or clinical development experience Fluent in English (verbal and written) Preferred Qualifications: Board certified or eligible in Ophthalmology Strong scientific and academic background with deep understanding of retina and eye diseases Clinical trial or pharmaceutical experience in ophthalmology Knowledge of drug development, ocular gene therapy, regulatory strategy Good networking ability in cross-cultural environment Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization Performance oriented with ability to work along agreed timelines and a focus on strategy and execution Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $75k-116k yearly est. 17d ago
  • Automation Technician

    Sanofi 4.3company rating

    Pennsylvania Job

    Job title: Automation Technician About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. *3rd shift* Overtime, holidays, and weekends as per business needs We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: This position will be responsible to provide support of all automated process control systems used in licensed manufacturing (including dedicated clean utilities) of the building that the Automation Site Support Manager has been assigned to. The position will be the Automation Site Support interface with Operations personnel, QA Compliance, Information Systems, Engineering, Maintenance and the site wide Automation Support technicians. The Automation technician must exhibit strong customer service and in-depth technical knowledge of process control systems and equipment used in biotech/ pharmaceutical manufacturing and utility systems. This position will support the highly complex automated systems installed in the new and existing manufacturing facilities, security and its support systems. Expected results from this position would include hands-on support of automated system in manufacturing, troubleshooting of automated process equipment and process systems, aiding in the investigation of process deviations and providing expertise for process evaluation. The position will provide improved response time to failures in manufacturing and implement site automation standard procedures and Global Engineering Practices. About You Education/experience: Highschool Diploma or Equivalent Associate degree in a technical area desired. A minimum of 5 years in automation and electro-mechanical engineering background and experience. Must have proven experience with the following automation service activities including: Understand Piping/Process & Instrumentation Diagrams (P&ID) Read, troubleshoot and repair hard-wired control systems using schematic and wiring diagrams. Strong electrical and mechanical troubleshooting is required. The ability to make logical repair decisions. Comfortable working around industrial and commercial equipment The ability to work safely with electricity ranging from 120VAC-480VAC Knowledgeable with pneumatic, hydraulic and steam control systems Capable of troubleshooting, online and offline programming and configuring PLC ladder logic and HMI/ SCADA database and screens Capable of troubleshooting and configuring automation network systems Knowledgeable of field instrumentation including transmitters, actuators and signal converters Knowledgeable of IT/IS systems and equipment, NEC classifications and NEMA ratings Comfortable with the use of hand tools and measuring equipment Ability to use and navigate windows software Must have proven experience in hands-on programming and configuration of Programmable Logic Controllers (PLC), and Supervisory Control & Data Acquisition (SCADA) such as the following manufacturers hardware and software products: Hardware: Rockwell: PLCs, Panelview OITs Emerson: DeltaV Siemens: Simatic Schneider Electric Network protocols including Ethernet TCP/IP, OPC, Allen Bradley DH+/DH485, and DNET, Metasys N1, N2, Software: Emerson Intellution: iFix Aveva: unified galaxy Emerson: DeltaV Rockwell: Studio 5000, Factory Talk view Siemens: WinCC Familiar with local and federal code requirements such as FDA CFR, NFPA/ NEC, OSHA, DEP, EPA and industry standards & guidelines including ISA, ISPE, GAMP5. Familiar with process and utility equipment such as fermentation, purification, clean steam generators, Water For Injection (WFI), Clean/ Sterilize In Place systems (CIP/ SIP) systems, Building HVAC controls, and water/wastewater treatment systems. A/I: Support maintenance standards for automation hardware installations and repairs I: Provide technical feedback on IoT setup to ensure stable integration I: Inform project requirements and task Progress for resource planning A: Document and verify compliance during routine maintenance I: Report improvement areas based on performance observations D: Decide on immediate troubleshooting steps and escalate complex issues as needed Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $49k-66k yearly est. 8d ago
  • Medical Science Liaison, Neuropsychiatry (San Diego, CA)

    Bristol-Myers Squibb 4.6company rating

    Chula Vista, CA Job

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Medical Science Liaison, Neuropsychiatry Location: San Diego/Orange County, CA The Medical Science Liaison (MSL) role embodies our medical mission to be recognized as the trusted partner for internal stakeholders and the healthcare community, driving scientific exchange to enhance medical education, data generation, insight generation and patients' access to medicine. The MSL is responsible for identifying disease and product related medical needs in a defined geography. The primary role of the MSL is to develop and maintain relationships with Thought Leaders (TL) and Healthcare Providers (HCP) within their territory. The purpose of their interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate use through peer-to-peer discussions aligned with medical strategies and needs expressed by external stakeholders, and to facilitate research. The MSL also serves as the medical resource for external stakeholders in the community. External Environment and Customer Focus Develop and maintain relationships with academic and community research thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product, and Health Economics and Outcomes Research (HEOR)-related questions. The MSL will use various channels for interactions (1:1, group presentations, remote, etc.) Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TLs/HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives. Actively assess the medical landscape by meeting with TLs/HCPs/Access Stakeholders to understand their needs and expertise. Continuously update their own knowledge in treatment strategies, products, unmet medical needs, clinical trials, health economics outcomes research and scientific activities. Understand the competitive landscape and evolving healthcare models and actively prepare to address informational needs of customers Identify opportunities to partner with HCPs on disease state initiatives, collaborative research projects, and investigator sponsored research (ISR) of interest and in alignment with BMS strategic objectives Attend medical congresses and local/regional meetings. Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to support strategy development and business decisions Contribute to the Medical Plan Develop geography-specific Field Medical and TL Interaction plans based on therapeutic area objectives and TLs needs Adopt institution/account planning approach and contribute to cross-functional institution/account plans Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan Provide Medical Support Establish a customer-centric, compliant collaboration with cross-matrix field teams within assigned geography As necessary and appropriate, support the initial and ongoing medical /scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Value Access & Payment) Provide scientific support at promotional meetings by presenting scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers (if applicable) Participate in assigned Congress activities Support Clinical Trial Activities Support Interventional and Non-Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to facilitate patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with home office medical and Global Development Operations (GDO) and as defined by the study scope document Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with home office medical and GDO Support HCPs in the ISR submission and execution process and study follow-up as agreed upon with home office medical and GDO Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events Actively support CRO sponsored studies as agreed with home office medical and GDO and as defined by the study scope document Required Qualifications Advanced degree in medical/biosciences (i.e., MD, PhD, PharmD, DPH, EdD, etc.) AND a minimum 3-5 years of MSL or clinical practice experience Current MSL or clinical practice experience in psychiatry, mental health or schizophrenia with proven track record of establishing, maintaining, and enhancing effective and successful collegial relationships with external experts. Knowledge Desired Disease area knowledge and an understanding of scientific publications Knowledge of a scientific or clinical area, competitive landscape and patient treatment trends Knowledge of clinical trial design and process Knowledge of the national healthcare and access environment Knowledge of HEOR core concepts Excellent English language skills, spoken and written Experience Desired A minimum of 2 years working in a clinical and/or pharmaceutical environment Prior MSL or clinical practice experience Ability to work independently and act as a team player Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals Developing peer-to-peer relationships with TLs, scientists and other HCPs Ability to quickly and comprehensively learn about new subject areas and environments Demonstration of the BMS Values Essential Qualification Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart) and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity, and a responsible and safe driving history. Travel Requirement Travel required. This position is field based and the MSL will be required to live within the territory they manage or within 50 miles of the territory borders. The MSL will spend the majority of their time in the field with external customers. Further requirements based on territory assignment and team needs. The starting compensation for this job is a range from $150,000 - $200,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #LI-Remote If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ************************** . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
    $150k-200k yearly 1d ago
  • CSV Engineer

    Sanofi 4.3company rating

    Pennsylvania Job

    Job Title: CSV Engineer About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Our Team/ Overview Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improve lives. Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways. Within our Sanofi Manufacturing & Supply Ambition, we’re redefining our strategy, culture, and processes to make a tangible impact worldwide. In this role, you'll join the Automation & Manufacturing Systems department at our Swiftwater site, supporting directly the manufacturing system automation computer system validation. As a Computerized Systems Validation Engineer, you are responsible to ensure that all automation computerized systems used in manufacturing processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Systems (e.g., environmental monitoring system [EMS], batch record management systems [MES], Data Historian, Process Control Systems (e.g., distributed control system [DCS], programmable logic controller [PLC]), Computerized Process Equipment, and other integrated systems. You will support the establishment and maintenance of automation computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: The Computer System Validation Engineer will be responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations. Design and execute validation protocols and testing. Create and manage validation documentation. Troubleshoot validation issues, conduct risk assessments and support audit. Record and analyze deviations and downtime for root cause identification. Provide technical expertise in CS validation lifecycle for OT systems. Ensure OT systems comply with regulatory and industry standards. Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly. Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices. Function as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports. Author CSV plans and procedures. Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory. Ensure continual improvement of CSV program by performing periodic review of the program. Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions. Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use. Provide support during regulatory inspections and site audits as quality oversight and SME of CSV. Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time. About You Education and experience: Bachelor’s or Master’s degree in Science, Engineering, or related Life Sciences or Technology fields. A minimum 4-7 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry. Key technical competencies and soft skills: Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV. Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems. Solid technical knowledge in the use and application of risk- and science-based approaches to CSV. Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines. Good communication skills to present validation strategies to the site management and other functions. Familiar with Digital 4.0 concepts and control systems. Able to work independently with little supervision. Experience with ensuring Data Integrity in computerized systems. Expertise in OT system validation processes and lifecycle. Knowledge of security patch management for control systems. Experience in backup protocol development and validation. Ability to analyze deviations and implement corrective actions. Understanding of regulatory and industry standards for OT systems. Strong problem-solving and documentation skills. Knowledge in DCS, PLC, SCADA, BMS, EMS and HMI systems Understanding of ISA-95, ISA-88 standards. Problem-solving and project management skills. Related KPIs and metrics: Timely validation and documentation updates. Percentage of applied and effective security patches. Backup procedure success rate and reliability. Reduction in OT system downtime incidents. Compliance adherence in validation processes. Disclaimer The above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $74k-98k yearly est. 26d ago
  • Nurses (LPN or RN)

    Avante at St. Cloud, Inc. 3.5company rating

    Saint Cloud, FL Job

    Job DescriptionWork today, get paid today! Avante at St. Cloud offers DAILY PAY!! Full and Part-Time Available! Newly Renovated Facility! Are you a Licensed Practical Nurse (LPN) or Registered Nurse (RN) seeking an exciting new opportunity? Are you an LPN or RN looking for a place where you can focus on patient care and make a real difference? Avante Group, Inc. has the perfect place for you! For almost 35 years, Avante has specialized in skilled nursing, assisted living, rehabilitation, and post-acute services. Our associates are committed individuals , who desire to create an environment that fosters wellness, integrity, and success. At Avante, you will have the opportunity for advancement, you will learn new skills, meet new people, build rewarding professional and personal relationships, and improve the quality of life of those around you. The LPN or RN will provide direct nursing care to the residents and will perform the day-to-day nursing activities in accordance with current federal, state and local standards governing the facility, and as directed by the Director of Nursing Services, Assistant Director of Nursing Services and Administrator, to ensure that the highest degree of quality care is maintained at all times. Must be a Licensed Practical Nurse (LPN) or Registered Nurse (RN) in good standing and meet all applicable federal and state licensure requirements. Must speak and understand English. - Must be knowledgeable of nursing and medical practices and procedures and laws, regulations and guidelines governing long-term care. Positive attitude toward the elderly. Why Avante? At Avante, we believe in providing the highest quality of care to our residents while fostering a supportive and rewarding work environment for our team. Benefits You'll Love: Competitive Compensation Comprehensive Insurance Coverage (Medical, Dental, Vision and more!) Strong Retirement Plan for Your Future Paid Time Off & Holidays to Recharge Tuition Reimbursement - Invest in Your Education Health & Wellness Programs to Keep You Feeling Your Best Employee Recognition Programs - Win prizes & an annual cruise! A Collaborative Work Environment - We value your voice! (Employee surveys, check-ins, & town halls) Advancement Opportunities - Grow Your Career with Us! Don't Hesitate- Apply Today! Avante provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, Veterans' status, national origin, gender identity or expression, age, sexual orientation, disability, gender, genetic information or any other category protected by law. In addition to federal requirements, Avante complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Avante expressly prohibits any form of workplace harassment based on race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, Veterans' status or any other category protected by law. Improper interference with the ability of Avante's employees to perform their job duties may result in discipline, up to and including, discharge.
    $45k-62k yearly est. 23d ago
  • Specialist, E-Commerce

    Universal Orlando 4.0company rating

    Orlando, FL Job

    Universal Orlando Resort believes in-person collaboration is key to our success. Many of our Team Members work in a hybrid capacity, contributing from the workplace a minimum of three days per week. There are also roles that require being on-site full time. Limited remote opportunities may be available within specific departments. You’ll learn more about this during the recruitment process. JOB SUMMARY: This position will assist in the enhancement and improvement of our E-Commerce online guest experience and collaborate with multiple partners to execute a merchandise strategy to drive sales growth. Responsible for the day-today analysis of sales and inventory data; tracking performance against all DTC/MOD (Direct to consumer / Merch on demand) KPIs and SLAs; present findings; generate reporting; identify trends; and create accurate sales and inventory forecasts, to achieve financial goals. They will work closely with the UDX/UOR E-Commerce team to support other initiatives that directly impact our broader UDX DTC business. MAJOR RESPONSIBILITIES: Collects, analyzes, and interprets sales, inventory, customer behavior, and marketing performance data. Summarizes results, provides insights, and makes recommended actions on UDX eCommerce performance. Creates eCommerce reporting that provides insights on financial results, sales, inventory, key performance indicators (KPIs), and 3rd party SLAs. Report the facts, provide insights on performance, and share recommended actions. Analyzes purchase and channel trends and concisely communicate learnings to internal partners. Provides recommendations to category planning and inventory analysts teams to drive inventory decisions to support our current and future financial goals. Communicates inventory needs to internal planning and inventory analysts’ partners to ensure initial inventory and replenishment orders support the financial goals of the eCommerce channel. Partners with 3rd party partner on inventory demands and gain alignment and approval with internal partners before transferring inventory. Plans the movement of inventory from our UDX warehouses to our 3rd party partner. Communicates the inventory plan to 3rd party partner. Executes the systemic transfer of inventory and partner with logistic and supply chain teams to execute inventory transfers. Tracks the physical and systemic transition of inventory and the timely receipt. Partners with UDX finance to build an eCommerce channel daily, weekly, monthly, quarterly, and annual order/sales/unit forecast. Shares with 3rd party partner for eComm order and resource planning to ensure they hit our fulfilment SLAs. Build top-down Brand and Category forecasts, share with partners to influence eCommerce channel assortment and inventory plans. Works with a many internal and external partners (e.g., finance, location planning, brand & category merchandising, planning and inventory, marketing, logistics, and site operations) to ensure alignment, and gain support for the eCommerce channel goals. Understands and actively participates in Environmental, Health & Safety responsibilities by following established UO policy, procedures, training and team member involvement activities. Performs other duties as assigned. EDUCATION: Bachelor’s degree is preferred in a related field; or equivalent combination of education and experience. EXPERIENCE: • 2+ years’ in an Ecommerce or similar role. ADDITIONAL INFORMATION: Advanced PC skills, including but not limited to Microsoft Excel, Access, Word, Relational databases, and SQL required. Understanding of key retail financial planning processes/concepts (e.g., financial forecasting, sales and inventory planning and analysis) and their typical application in a retail environment preferred. Flexible and adaptable regarding learning and understanding new technologies. Strong written, oral, and interpersonal communication skills. Highly self-motivated and directed. Keen attention to detail. Proven analytical and problem-solving abilities. Ability to effectively prioritize and execute tasks in a high-pressure, fast-paced, dynamic environment. Experience working both independently and in a team-oriented, collaborative environment across various time zones. Demonstrated self-starter with strong organizational skills and the ability to take ownership, work independently, and produce accurate and timely results. Capable of balancing competing priorities while working on a variety of activities that span across many different functions. Your talent, skills and experience will be rewarded with a competitive compensation package. Universal is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Universal Orlando via-email, the Internet or in any form and/or method without a valid written Statement of Work in place for this position from Universal Orlando HR/Recruitment will be deemed the sole property of Universal Orlando. No fee will be paid in the event the candidate is hired by Universal Orlando as a result of the referral or through other means. Universal Orlando Resort. Here you can. Universal Orlando is an equal opportunity employer. Universal elements and all related indicia TM & © 2025 Universal Studios. All rights reserved. EOE
    $48k-61k yearly est. 9d ago
  • Analytical Chemist

    Delcath Systems 3.6company rating

    Queensbury, NY Job

    Job Title: Analytical Chemist Department: Quality Control Reports To: Quality Control Supervisor FLSA Status: Salaried Date Prepared: May 2025 The Chemist will play a critical role in product release testing and will participate in QC/ R&D activities related to product development. The incumbent must demonstrate a high level of involvement in continuous improvement activities to ensure the highest standards are maintained. The Chemist must possess the ability to solve practical problems and deal with a variety of situations in a fast-paced environment. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Assist with the end-to-end process of batch release testing which includes but not limited to preparation of drug solution, sample collection, data review/ analysis, and other. Proactively take measures to ensure that all equipment is current with calibration and PM services, where applicable. Comply with GDPs for maintenance of data and records. Maintain knowledge of organizational SOPs and apply where needed. Participate in developing and validating QC test methods while complying with Quality Management Systems (QMS), in accordance with ISO standards and regulatory requirements. Responsible for R&D activities including writing/ executing protocols, preparing standards/ reagents/ solutions, analysis of samples using LC-MS on a routine basis. Responsible for maintaining the LC-MS instrument per set requirements. Assist with effective planning and organizing of R&D lab activities to meet set project deliverables. Collaborate with peers/ external teams to organize and conduct research. Comprehend, and effectively communicate technical data across cross-functional teams. SUPERVISORY RESPONSIBILITIES None. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE · A minimum of bachelor's degree in chemistry or life sciences is required. · Knowledge and experience working in Quality Control is required. · Must be instrumental with UPLC-MS/MS with an experience in MassLynx application software and method development techniques. A minimum of 2 years' experience is required. · Ability to effectively identify/ trouble shoot instrument related technical problems, as needed. · Ability to read, understand, and conduct USP/NF raw materials official monograph testing is required. · Ability to read and understand peer reviewed journals/ research articles. · Must possess strong analytical problem solving and process skills, and be computer proficient in EXCEL, Word, etc. · Must be willing to learn any new application as needed. · Must be team oriented, with the ability to work well with diverse cross-functional teams. · Must possess strong verbal and written communication skills. · Must possess ability to apply common sense understanding to carry out instructions in written, oral, or schematic form. LANGUAGE SKILLS Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organizations. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.
    $67k-92k yearly est. 1d ago
  • US Gen Meds, TID Franchise, Senior Director Marketing MSA Acceleration

    Sanofi 4.3company rating

    Cambridge, MA Job

    Job Title: US Gen Meds, TID Franchise, Senior Director Marketing MSA Acceleration About the Job The Head of MSA Acceleration Marketing will be responsible for leading, developing and executing the marketing strategy for the defined Acceleration MSAs, ensuring alignment with the national Brand strategy while adapting to the MSAs unique market dynamics. This role will oversee all aspects of the MSA related marketing, including development of the MSAs strategy in collaboration with the RSL, local marketing mix definition and messaging localisation. This role will spearhead the test & learn approach in the Innovation Lab MSAs. The Head of MSA Acceleration Marketing works in close alignment with the Head of Central Marketing who is in charge for acceleration strategies for the non-MSA regions, as well as with each function of the central marketing team, the functional leads of the matrix organization. This role reports to the Head of MSA Acceleration fixed line, to the Head of Marketing in dotted line and is part of the MSA Acceleration Leadership Team as well as the Central Marketing Leadership Team. We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue Progress to make a real impact on millions of patients around the world. Main Responsibilities: Own the process of developing, executing, and optimising the MSA Acceleration Program through dedicated strategies for Acceleration MSAs in close collaboration with the respective Regional Strategic Leads (RSL) and all matrix functions. Accountable for defining the Digital, Influencer & NPP strategy for each MSA based on strong recommendations and in strong collaboration with the central marketing and communication team Accountable for developing outstanding market development & patient engagement strategies for MSAs in close collaboration with central Marketing, CORE and Public affairs. Define key localisation opportunities to tailor messaging, content and campaigns to resonate with local MSA audiences. Contribute to the development of modular and scalable content to accelerate localisation opportunities. Leveraging local insights (e.g. market access coverage, local labs & coding, DKA rates, etc.) and work closely with central marketing team to develop and execute them. Lead an agile test & learn approach in the 2 “learning lab” MSAs by co-developing together with central marketing new strategies & tactics, testing them and providing structured feedback and recommendations to central marketing for national rollouts. Be the Marketing Business Partner for Acceleration MSAs, act as a unique go-to person for all marketing related topics and link with central marketing team and other functions for solutioning. Be a clear voice and consult the national brand strategy development, bring in the MSA perspective and support the development of impactful national strategies. Manage relationships and coordination across Central Marketing and all functions of the matrix organization (esp. CORE, Public Affairs and Communication) to ensure all are appropriately deploying and prioritizing resourcing and engagement according to defined MSA acceleration strategies in alignment with national marketing strategies. Develop and manage the MSA marketing budget for all Acceleration MSAs including flex funds, speaker events, local events and regional conferences in close cooperation with central marketing functions. About You Bachelor's degree; MBA is highly valued 10+ years professional experience with 7+ years across critical functions including HCP or Consumer focused Marketing, Market Access or similar relevant experience Experience working in Type 1 Diabetes / Rare disease areas Proven experience in leading the local strategy development, engagement plan development, insights and analytics to plan impactful pull-through High emotional intelligence and an inclusive leadership style, with a track record of leading cross functional teams and collaborate with a range of different functions to achieve outcomes Experience of external / customer interactions, market research and demonstration of complex project management Executive communication skills, ability to communicate to audiences of varied sizes and levels, both Head office and Field Sanofi US is only considering candidates who are currently legally eligible to work in the U.S. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
    $145k-191k yearly est. 14d ago
  • Art Therapist (mental health)

    Christian Children's Home of Ohio 3.6company rating

    Wooster, OH Job

    SUMMARY: The CRC Art Therapist evaluates, prepares, and adapts art therapy treatment for clients in the Children's Residential Center. The Art Therapist is able to work with individuals with the goal of improving clients' psychological, social and physical well-being. Using the creative process, the art therapist will help clients improve self-confidence, increase self-awareness, gain insight into social, emotional, and behavioral struggles, as leading into the identification, processing, and resolution of past traumatic events to improve overall functioning. This is done in collaboration with the Trauma Program Leader. ESSENTIAL DUTIESRESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. It is the responsibility of each employee to be a consistent witness for Jesus Christ and to adhere to the Statement of Faith/Standard of Moral Conduct. Further, each employee is responsible for dealing with others with a Christ-like attitude while helping them experience their worth in Christ and demonstrating behaviors reflecting CCHO's core values of Relentless Commitment, Selflessness, and Kindness. Job-specific essential functions include the following: TEAM FIRST: Makes every effort to maintain a 'team first' spirit and atmosphere within the workplace environment, maintaining appropriate working relationships and promoting collaboration. Maintains a supportive relationship with clients by providing them with a secure and stable therapeutic space to process past trauma. Assesses clients' psychological, social, and physical level of functioning in order to determine needs/strengths. Establishes art therapy goals and objectives related to achieving trauma resolution, implements art interventions that are consistent with the art therapy objectives established in the treatment plans. Understands inherent aspects and potential effects of media properties, evaluates client interaction with media during sessions, selects appropriate media of visual expression based on client response to art interventions. Facilitates individual art therapy sessions, guides efforts of self-expression in the creative process, implements mindfulness techniques to aid clients in gaining insight and becoming more self-aware of underlying thoughts, feelings, motivations for behaviors. Facilitates group sessions, assisting individuals to understand and overcome past trauma and find hope and insight into their preset and future dreams/goals through the use of art therapy interventions. Engages residents in identifying, understanding, and neutralizing effects of past trauma on current functioning, encourages exploration of insight into their present and future goals. Regularly evaluates the effectiveness of interventions and therapeutic modalities provided, adapts them according to the evolving needs and abilities of each client. Completes appropriate documentation and paperwork including, but not limited to, progress notes after each therapy session, quarterly treatment plan updates, weekly progress updates to cottage clinical teams, monthly progress updates to clinical case managers. Develops and maintains appropriate records on clients. Ensures art materials are readily available and maintains regular inventory. Collaborates with cottage therapist and trauma program leader to ensure continuity of care and trauma resolution. Coordinates, organizes and implements art activity programs. Provides treatment/interacts with clients and families utilizing Trust Based Relational Intervention modality Provides lethality assessments/recommendations for care, makes recommendations when needed. Participation in agency and professional training and collaboration with cottage teams. Provides mental health training to cottage staff as directed/assigned. Other duties may be assigned. SUPERVISORY RESPONSIBILITIES: None. REQUIRED SKILLSABILITIES: Ability to facilitate mental health services using various types of art to engage clients. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedure, or governmental regulations. Ability to read, comprehend and write routine reports and correspondence. Ability to effectively communicate before groups of varying sizes of clients, employees or members of the public. Excellent interpersonal skills, including conflict resolution, required. Must be able to communicate well with colleagues, verbally and in writing to ensure safety and efficiency. Ability to multi-task and prioritize assignments. Excellent organizational skills and attention to detail. Ability to apply common sense, to define problems, collect data, establish facts, and draw valid conclusions. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Ability to deal with variety of abstract and concrete variables. Competency with Microsoft Office Suite and the internet, as well as CCHO clinical documentation software (electronic health record). Ability to function well in a fast-paced environment, as well as cope and tolerate high levels of stress. EDUCATION, EXPERIENCE, CERTIFICATIONS/LICENSES: Master's degree (MA) or equivalent, preferably in Art Therapy, Social work, or Clinical Counseling. Coursework in art therapy required for non-art therapy degrees. License in social work (LSW), counseling (LPC), or art therapy (LPAT) required. Independent licensure preferred. Four to ten years related experience in art therapy and/or training; or equivalent combination of education and experience. Art therapy certification(s) strongly preferred. Demonstrated knowledge/proficiency in, and passion for, visual art. Demonstrated knowledge of art therapy theories, techniques, and practices. Valid Ohio Driver's License and a driving record that allows that individual to be insurable on agency policy, as job includes occasional travel. PHYSICAL REQUIREMENTS: Ability to speak and be easily understood. Frequently required to walk, sit, talk, and hear, including a requirement to stand or walk for extended periods of time, sometimes through uneven terrain. Often required to use hands/fingers, handle or feel; reach with hands and arms, climb or balance and stoop, kneel, crouch or crawl. Specific vision abilities required include close vision, distance vision, depth perception, and the ability to adjust focus. Regularly able to lift/move up to 25 pounds. Must be able to be outdoors in various weather conditions for extended amounts of time. Specific vision abilities required by this job include close vision, distance vision, depth perception and ability to adjust focus. Must be able to drive a vehicle legally and safely in the state of Ohio. Must maintain compliance/certification with CCHO's requirements for using physical restraints (SCM: Safe Crisis Management), including sufficient strength and completion of extensive training. Physical ability to respond to crisis, including, but not limited to running and performing physical restraints. CONTINUOUS QUALITY IMPROVEMENT (CQI): All Agency staff are expected to focus on Quality improvement as a part of their job responsibilities, in an effort to make the Agency a safe and healing environment for clients and staff. This expectation includes, but is not limited to teamwork, improving service delivery, fulfilling department goals, and other job-specific tasks that encourage excellence.
    $37k-51k yearly est. 2d ago
  • Senior Data Scientist AI Strategy and Activation - Remote Opportunity

    Lundbeck LLC 4.9company rating

    Lundbeck LLC Job In Deerfield, IL Or Remote

    Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote Opportunity - Open to candidates anywhere in the greater United States POSITION SUMMARY: Lundbeck US is seeking a dynamic, motivated, and highly experienced individual for the position of Sr. Data Scientist AI Strategy & Activation. This individual will support the implementation of the US AI strategy and activation that is aligned with business goals driven by portfolio strategic priorities. This individual will also be responsible to identify and leverage opportunities to utilize AI for innovation and growth across Lundbeck US. ESSENTIAL FUNCTIONS: * Design, train, test, and deploy AI/ML models and algorithms to generate actionable insights for business teams and optimize existing processes. * Collaborate with cross-functional teams, including data engineers, software developers, and product managers, to understand business requirements, design AI solutions, and ensure successful integration of AI-driven solutions. * Conduct thorough data exploration and preprocessing and identify features to improve model performance. * Fine-tune and optimize models for production environments to meet performance, speed, and scalability goals. *
    $83k-117k yearly est. 48d ago

Learn More About Lundbeck Jobs

Jobs From Similar Companies

Jobs from similar companies you might want to view.

Most Common Locations At Lundbeck

Zippia gives an in-depth look into the details of Lundbeck, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Lundbeck. The employee data is based on information from people who have self-reported their past or current employments at Lundbeck. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Lundbeck. The data presented on this page does not represent the view of Lundbeck and its employees or that of Zippia.

Lundbeck may also be known as or be related to Lundbeck, Lundbeck Inc, Lundbeck Inc. and Lundbeck Korea Co., Ltd.


OSZAR »