- Merck & Co. (Upper Gwynedd, PA)
- …Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory Submissions, ... risk mitigation measures.-Lead development and execution of global product and project regulatory strategy (ies) by ensuring robust assessment of global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV ... Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual is...preparedness for the respective MA inspections in alignment with regulatory and company strategy . Act as management… 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...area and team leading to global innovative and accelerated regulatory strategy and marketing authorizations for Cardiovascular,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... including working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in preparation… 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 ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Leica Biosystems (Miami, FL)
- …System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion ... regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director, Policy. Other internal relationships include a dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Merck & Co. (Rahway, NJ)
- …(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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other functional teams in NNI (including MAPA), including marketing, medical, R&D, regulatory affairs , finance, NNGlobal, and other relevant entities to develop ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (North Wales, PA)
- …areas, including but not limited to, Marketing, Learning & Development, Regulatory Affairs , and LeadershipDemonstrate operational efficiency by leveraging best ... the organization with the mission to achieve business excellence. The RCLO Senior Specialist is responsible for supporting and improving the processes for creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data to inform strategy adjustments and improve execution Health Systems Strategy Support o Collaborate with medical affairs and market access teams ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing… 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 solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …consumer interactions, and making recommendations for execution improvements Health Systems Strategy Support Collaborate with medical affairs and market access ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… 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 ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (Rahway, NJ)
- …barriers to reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn ... Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , and other relevant NNI departments to ensure alignment ... center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data… more
- Merck & Co. (North Wales, PA)
- …incumbent has the following responsibilities:1.) development of the integrated evidence strategy to support HTA/ reimbursement/ NITAG evaluations; 2.) development of ... Product Development Teams, Franchise Teams, Regional Product Directors, affiliates, Public Affairs , and Medical Education to ensure value evidence programs are… more
