- 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. (Millsboro, DE)
- Job DescriptionSUMMARY OF POSITIONThis position is responsible for ensuring regulatory filings of animal health products in pursuance of licensure and marketed ... are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in the US however closely… 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- …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
- 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
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Team, the Vice President of Preclinical Research & Development will develop and lead the all of the Institute's Contract Research activities and functions to ... fostering innovation across Lovelace's scientific functional areas, specifically:Operational Leadership: Lead the seamless daily operations of Lovelace's research facility.… more
- Merck & Co. (Rahway, NJ)
- …within a regulated supply environment.Responsibilities include but are not limited to: Lead and oversee analytical investigations with a strong focus on quality and ... regulatory compliance.Excel in impurity isolation, unknown peak identification, characterization of degradation pathways, and trace impurity quantitation (eg,… 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)
- … regulatory inspections. Independently performs audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to ensure ... accompanying the disposition of API materials to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or… 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
- 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
