- Novo Nordisk Inc. (Plainsboro, NJ)
- …needed and handle other duties and/or special projects as assigned by Regulatory Management Physical Requirements 0-10% overnight travel required. Qualifications ... the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies… more
- Merck & Co. (Rahway, NJ)
- …and revised regulations, final guidance and standards.Provide strategic advice to senior management on CMC regulatory matters based on health authority feedback ... updates.Supports device sites with the collection and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and… more
- Merck & Co. (Rahway, NJ)
- …and regulatory bodies to support product launches and lifecycle management . Education : Bachelor's Degree in Engineering, Life Sciences, or a related ... Job DescriptionThe Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality assurance and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- BioAgilytix (Durham, NC)
- …life-saving therapeutics to the patients who need them.The Sample Management Specialist is responsible forGxP-compliant processing of incoming and outgoing ... consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)Resolves discrepancies, with responsibility for investigating and… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director, Asset Management & Reliability, in this role as Associate Director Asset Management & Reliability CoE, you will be ... responsible for overseeing Asset Management , Maintenance and Reliability activities to support Vaccine, Sterile, Pharmaceutical, and External Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... around rare diseases and immune disorders. Summary The Manager External Data Management , is accountable for an end-to-end delivery of External data in Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... rare diseases and immune disorders. We are currently seeking a Global Project Management and Leadership Intern for summer 2025. This full time position works for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as well as HCP related strategies on KOL engagement and early market education . This role is responsible for the development of the patient advocacy strategy ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director, Development SOP Management Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (Upper Gwynedd, PA)
- …:Bachelor's or equivalent in relevant health care area. Further formal education in quality management or business management is desirable.Master's ... for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.Primary Responsibilities:Operational… more
- Merck & Co. (Rahway, NJ)
- …expertise in cell culture and fermentation sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry OR ... expertise in cell culture and fermentation sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry ORPh.D.… more
- Merck & Co. (Rahway, NJ)
- … regulatory related projects, as needed. Position Qualifications : Education Minimum Requirement: Detailed working knowledge of Hazard Communication and ... Job DescriptionPosition Description: Senior EHS Specialist Corporate Chemical Management and Product Stewardship The Senior EHS Specialist is a member of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the most diverse and collaborative groups within the organization. From health- care -provider interactions and developing and implementing regulatory strategies ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements. Key contact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and ... creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
