- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Merck & Co. (Upper Gwynedd, PA)
- …all assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for ... milestones through product development including assessment of the probability of regulatory success together with risk mitigation measures.- Lead development and… more
- BioAgilytix (Durham, NC)
- …and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, ... checks.Establish automated data validation and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionAs a Principal Data Scientist - Medical Imaging at Formation Bio, you will lead ... pioneer the application of computer vision and deep learning to medical imaging data (MRI, X-ray, CT, PET) to accelerate clinical trials and improve patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …be responsible for driving customer impact by overseeing 5D efforts including Data , Diagnostics, Drug, Device, and Digital strategy and execution for relevant TAs, ... Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Genmab (NJ)
- …CommitteesReview and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activitiesExperience:Master's or PhD ... expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (North Wales, PA)
- …solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory ... to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Genmab (NJ)
- …products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Twist BioScience (South San Francisco, CA)
- …Architect and ensure the accuracy, integrity, traceability, and security of all manufacturing data within the MES, critical for regulatory submissions and audit ... experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom,… more
- Merck & Co. (Rahway, NJ)
- … Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, Regulatory ... 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)
- …clinical/scientific 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 interpretation of clinical data /medical protocol deviations in collaborations with the Clinical Director.Other responsibilities… more
- Insmed Incorporated (San Diego, CA)
- …in various analytical techniques and instrumentation is necessary, as is knowledge of regulatory guidelines like cGMP and ICH, and data integrity principles such ... a Receiving Unit (internal or external QC). May act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations… more
- Formation Bio (New York, NY)
- …and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing ... biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Merck & Co. (Rahway, NJ)
- …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 interpretation -of clinical data /medical protocol deviations in collaborations with the Clinical Director....clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and… more
- Insmed Incorporated (San Diego, CA)
- …managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related ... maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic… more
- Genmab (NJ)
- …as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of concept, and/or as trial responsible ... statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for designated compound/indicationFollow… more
