- 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 ... manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the … more
- Eisai, Inc (Raleigh, NC)
- …The Director will develop colleagues with expertise in relationship/project management , contract review and negotiation, demand planning, and logistics to ... The Director will develop colleagues with expertise in relationship/project management , contract review and negotiation, demand planning, and logistics to… 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 ... planning, data collection, and relevant activities aligning with Daiichi Sankyo and regulatory requirements.- Participate in vendor contract and MSA discussions,… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance.The Associate Director of Engineering position will ensure ... degree or MBA: 3 years with a PhD)Strong planning, scheduling, and time management skillsWorking knowledge of regulatory requirements in accordance with GMP… more
- Genmab (NJ)
- …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 ... and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other SPC Leadership Team members, and acts as back up support for Executive Director Contract Development o Manages Contract Managers responsible for ... to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts… more
- Merck & Co. (Durham, NC)
- …Analysis, PM optimization, RCA, etc.)Strong planning, scheduling, and time management skillsWorking knowledge regulatory requirements in accordance with ... and demonstrated experience of interacting with site, divisional or regulatory audits/inspections.Good oral and written communication skillsProject management ,… more
- Merck & Co. (Durham, NC)
- …and/or calibration and/or maintenance backgroundStrong planning, scheduling, and time management skillsKnowledge of regulatory requirements in accordance with ... Job DescriptionThe Associate Director , Utilities Electrical Engineer is a member of the Plant Engineering team providing technical support to the Durham Site.- The… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing ... (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and… more
- Merck & Co. (Durham, NC)
- …and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
