- Merck & Co. (Rahway, NJ)
- …Knowledge:In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.Familiarity with materials science , particularly as ... medical device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product ... This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory ...as a whole depend on us. Through cutting edge science and strong partnerships, we develop and market some… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... centered around rare diseases and immune disorders Job Summary: The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory … more
- Legend Biotech USA, Inc. (Detroit, MI)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Medical Science Liaison as part of the Medical Affairs team based in Great Lakes ... & IL). Role OverviewAs part of the US Medical Affairs team, the Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs)… more
- Merck & Co. (Rahway, NJ)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (North Wales, PA)
- …is responsible for ensuring data integrity, accessibility, and compliance with regulatory standards, while also enabling business users to derive actionable insights ... data governance approval process, ensuring compliance with internal policies and regulatory standards.Triage and respond to real-time inquiries related to data… more
- Merck & Co. (Rahway, NJ)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... the assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck & Co. (Rahway, NJ)
- …substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support enterprise ... commercialization teams across the end to end supply chain, and analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership and… more
- Merck & Co. (Rahway, NJ)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... MDCP assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... in support of the portfolio of work, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... and execution excellence across the portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck & Co. (Rahway, NJ)
- …will take our company leading pharmaceutical R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.-In BARDS ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Genmab (NJ)
- …compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Insmed Incorporated (San Diego, CA)
- …industry, come to Insmed to accelerate your career.RecognitionsConsistently Ranked Science 's Top EmployerInsmed is dedicated to creating a collaborative environment ... thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's...(CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
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