- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety , will be a product safety lead or… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Completes audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of new ... and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission. May use six-sigma methodology.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports as required by all regulatory authorities.Ensure a robust risk ... centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical..., Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety … more
- Eisai, Inc (Raleigh, NC)
- …line extensions or site manufacturing changes in collaboration with Product Quality , Regulatory Affairs, and Technical Operations.Establish productive business ... is your profile, we want to hear from you.The Director Western Supply Chain Management (SCM) Unit is accountable...accountable and/or responsible for providing an uninterrupted supply of quality products to patients and DCU customers in their… more
- Eisai, Inc (Exton, PA)
- …well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... 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 building… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device ... areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of… more
- Merck & Co. (Millsboro, DE)
- …(USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director of ... Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall… more
- Merck & Co. (Rahway, NJ)
- …knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety .Current Employees apply HERE ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The...Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing… more
- Merck & Co. (Durham, NC)
- …used to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for ... External Partner).-- Compliance:-Achieve compliance goals through a risk-based approach ( Safety Regulations, Quality Assurance, Risk Management, Deviation… more
- Formation Bio (New York, NY)
- … regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing ... bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing… more
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