- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist , CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist /Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- 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
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …responsibility and leadership of internal and external work.The Senior Scientist , Engineering position leverages scientific/technical experience to develop safe and ... lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director (Principal Scientist ) has primary responsibility for the planning and directing of clinical research activities involving new or marketed ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …Company's Research & Development Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The ... Principal Scientist is a senior scientific role tasked with working...and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist .BPR&D within Research Laboratories is committed to rapidly delivering diverse ... with the scientific community to influence the field.As a Senior Principal Scientist , you will drive various strategic initiatives and translate strategies into-… more
- Merck & Co. (Rahway, NJ)
- …of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist /Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently.About the PositionAs a Principal Data Scientist - Medical Imaging at Formation Bio, you will lead our efforts to ... to integrate imaging AI solutions into trial protocols and workflows Partner with regulatory teams to ensure imaging biomarkers and AI models meet FDA standards for… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, an Associate Principal Scientist /Associate Director, has primary responsibility for planning/managing real world and ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… 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. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Principal Scientist .BPR&D within Research Laboratories is on a mission to rapidly deliver diverse ... and engage with the scientific community to influence the field.As a Principal Scientist you will have the opportunity to influence the future direction of Upstream… more
- Merck & Co. (North Wales, PA)
- Job Description Position Description This position is for a principal scientist in biostatistics.-The candidate should have a solid knowledge of statistical ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist /Director, Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Boston, MA)
- …in West Point, PA is seeking a highly motivated Associated Principal Scientist with wide knowledge of pharmacokinetic (PK) and toxicokinetic (TK) principles and ... and definitive/Good Laboratory Practice (GLP)], serving as a contributing scientist /principal investigator on toxicity studies, and executing PK/TK strategies to… more
- Aequor (South San Francisco, CA)
- Onsite USSF Scrubbed resume attachedJob Description The scientist will be a member of a team providing support for the early-stage pipeline of small molecule (SM) ... results that support the generation of publications, patents, or regulatory submissions and mentoring research associates and laboratory assistants. Preferred… more
- Aequor (Thousand Oaks, CA)
- …is 3 days onsite per week. The ideal candidate is a Data Scientist with a strong engineering background, preferably in Mechanical, Biomedical, or Chemical ... software-focused backgrounds, are not a fit for this role.The Digital Data Scientist will support the Combination Product Operations organization by improving the… more
