- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... External stakeholders include Healthcare professionals, HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead(s), Global Safety … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt level position with… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Tris Pharma (Monmouth Junction, NJ)
- Associate Director / Director , Analytical Research and DevelopmentMonmouth Junction, NJ Analytical Development, R&DDescriptionTris Pharma, Inc. ... Junction, NJ headquarters has an immediate need for an experienced Associate Director / Director , Analytical Research & Development. Job Title commensurate with… more
- Merck & Co. (Millsboro, DE)
- …for the Millsboro, DE biologics manufacturing site.Lead numerous projects including process improvement and safety initiatives.Coordinate / oversee capital ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...the Site Leadership Team and is responsible for the management and leadership of the Animal Services Department.Essential Duties… more
- Merck & Co. (Rahway, NJ)
- …and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … process optimization, customer technology transfer activities with project management assistance.Provide SME information on the request for pricing (RFP) ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...functional team staff in areas such as quality, compliance, safety , project planning, process development, technology development.Communicate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting ... Director , Clinical Development Join a Legacy of Innovation...assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Market Access strategy and tactics and in alignment with business planning process Oversee the management of qualitative and quantitative marketing research ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety ... assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Method Development & Testing is responsible for leading a Center of Excellence (CoE) focused on developing and validating ... nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and develops a team responsible for providing routine functional… more
- Merck & Co. (Rahway, NJ)
- …updates.Supports device sites with the collection and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality ... Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device...& Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position is… more
- Insmed Incorporated (San Diego, CA)
- …company at regulatory meetings including presentation at Advisory Committee Meetings.Preparing safety charters, DMC charters, or other specific management plans ... for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead… more
- Merck & Co. (Rahway, NJ)
- … level.--Participates in the recruitment, interview, candidate selection process in addition to performance improvement plan/termination as necessary.--Assumes ... or management experienceStrong knowledge of Clinical Development through submission Process , ICH, GCP guidelines and CFR 21 regulations related to Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …progress and status of informatics projects. Contribute to the R&D IT portfolio management process and participate in IT and R&D governance forums.Provide ... functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety ... Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Computational Toxicology group within the Nonclinical Drug Safety (NDS) division at our company is actively seeking an enthusiastic AI/ML data ... at the forefront of AI/ML application and data science methodologies towards drug safety prediction.Note: This position is available in South San Francisco, CA or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… more
