- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… 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
- 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. (Rahway, NJ)
- Job DescriptionThe Associate Director- Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is ... a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJOB DESCRIPTION SUMMARYThe Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design, coordinate, monitor, and report ... clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data… 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 ... like a fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within Clinical… 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. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director. Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director, Rare Bleeding Health Care Professional Marketing Experience has overall ... Reports to the Rare Bleeding Disorders TA lead (A/B). Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding Disorders TA and… more
- Merck & Co. (Durham, NC)
- …life-saving medicines and vaccines, including our HPV vaccines.DescriptionThe Quality Associate Specialist provides guidance/direction on the shop floor during ... and compliance guidance to employees, colleagues or clients.FUNCTIONAL EXPERTISE:The Associate Quality Specialist will be responsible for comprehensive management of… 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)
- …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 ... smooth trial operations. The Sr CTA assists with study documentation, regulatory compliance, communication between stakeholders, and overall trial coordination. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director, Strategic Collaboration role is responsible for fostering partnerships with ... the rare disease landscape, including knowledge of key stakeholders, regulatory requirements, and emerging trends Exceptional negotiation, communication, and… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility.- ... The Associate Principal Scientist is a laboratory-based scientific role tasked...molecular biology and immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… 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...external sites and be familiar with current industry and regulatory requirements on CCIT.This position will involve method troubleshooting,… 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 preferably ... Science or Business experience preferably in the biotechnology or pharmaceutical industry Associate 's degree and 6 years of Life Science or Business experience… more
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