- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to… more
- Eisai, Inc (Nutley, NJ)
- …life cycle management of existing products. May serve as the lead regulatory representative on the project team throughout the product lifecycle. Provide ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction...regulatory strategies and programs. Directs and manages a team of regulatory professionals responsible for development… 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, ... disclosure for collection, retention, testing and retesting of samplesProject Team Participation: Provide device-specific regulatory insight/guidance during CDx… more
- Eisai, Inc (Nutley, NJ)
- …needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing education initiatives including ... hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning...as congress activities. The position serves as a functional lead on cross functional launch planning and other strategic… more
- Novo Nordisk Inc. (WA)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge ... from other departments (Corporate Tax, MA, Comm'l BUs, Medical, Regulatory , Legal, etc) Assigned policy areas may include, but...positions Educate and enable broader Market Access and Public Affairs Teams, Corporate Tax team , and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ... than ever before. The Position The Thought Leader Liaison Lead plays a pivotal role leading a team...between thought leaders and internal stakeholders, encompassing R&D, medical affairs , marketing, and market access teams, to drive innovation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs , Integrated Customer Engagement, Global and other relevant NNI ... for Rare Disease speaker programs, identifying targeted outcomes and crafting tailored experiences Lead team to establish unmet needs, remove barriers to brand… more
- Eisai, Inc (Nutley, NJ)
- …The AD will work cross-functionally as a strategic partner with the broader Medical Affairs team as well as the Publications & Scientific Communications teams ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (South San Francisco, CA)
- …as immunology, neurology, cardiometabolic and others as needed by the pipeline.Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... scientific direction of companion diagnostics (CDx). - Specifically, the Diagnostics Lead will develop and execute diagnostic strategies and interact with various… more
- Merck & Co. (Rahway, NJ)
- …efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, Regulatory Reporting, … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge ... collaboration partners include the entire Market Access & Public Affairs Team , PCOR (Pricing, Contracting, Operations and...described below Drive Formulary Placement for NNI Products: Independent lead within NNI to develop RFP response for the… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... and technology make us unique, but it is our team members that set us apart; they are the...methods, specifications, protocols and reports. She/he acts as MV lead for assigned projects regularly reporting status/issues to management,… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... 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
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... rapid process development. May act as a Process Development Team representative as an Analytical Lead for...issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...and segmentation to inform actionable plans. KOL Experience Strategy: Lead the development and execution of KOL experience strategies… more
- Twist BioScience (South San Francisco, CA)
- …and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who… more
- Merck & Co. (Rahway, NJ)
- …industry standards.Collaborate with cross-functional teams, including R&D, marketing, sales, and regulatory affairs , to ensure the successful launch and ... seeking a highly skilled and experienced Director of Companion Animal Vaccine to lead our efforts in developing and managing our companion animal vaccine portfolio.… more
- Eisai, Inc (Nutley, NJ)
- …project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise ... want to hear from you. The Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the… more
