- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… 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. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Durham, NC)
- …a successful Validation support of the vaccine manufacturing facilities.The Associate Director, Validation will be responsible for providing Validation leadership ... on the customer. Author, review, and/or edit technical documents to support regulatory filings Author and approve validation procedures in accordance with our… more
- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead ... purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined...we would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic… more
- Aequor (Aliquippa, PA)
- … or Business experience preferably in the biotechnology or pharmaceutical industry OR Associate 's degree and 6 years of Life Science or Business experience ... Science or Business experience preferably in the biotechnology or pharmaceutical industry Associate 's degree and 6 years of Life Science or Business… 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 ... areas centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... that touch every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and… more
- Merck & Co. (Durham, NC)
- Job Description Position Description: The Associate Director, HVAC & Utilities Engineer is a member of the Plant Engineering team providing technical support to the ... systems regarding functionally of equipment and relied on as SME during regulatory discussions for HVAC/R. PROBLEM SOLVING: Identifies and resolves technical and… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… 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 ... a fit? Then we would love to have you join us!The RoleAs Senior Clinical Trial Associate (Sr CTA) you play a key role in supporting Clinical Trial Team (CTT) and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead, Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... group has an opening for an Associate Principal Scientist based in Rahway, NJ. Join us...one of strong ethics & integrity, diversified experiences, exceptional science , and a resounding passion for improving human health… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible ... for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong… 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 ... effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and… 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 ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical… more
- Merck & Co. (North Wales, PA)
- …our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people around the globe. We are ... currently recruiting for Associate Director, US MarketingThe role will oversee foundational strategy...align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an… 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 ... and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to… more
