- 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...health authorities.- Leads, develops, and coaches a team of senior level employees to effectively manage programs and enable… 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 ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory ...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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 ... Tax, as well as other Market Access & Public Affairs teams, Medical , Legal, Compliance, Communications and...insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical , Regulatory , Legal, etc) Assigned policy areas… more
- Merck & Co. (Upper Gwynedd, PA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance, Regulatory Compliance,… 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
- Merck & Co. (North Wales, PA)
- …areas, including but not limited to, Marketing, Learning & Development, Regulatory Affairs , and LeadershipDemonstrate operational efficiency by leveraging best ... with the mission to achieve business excellence. The RCLO Senior Specialist is responsible for supporting and improving the...review and label update processes and collaborate with the Medical Legal Regulatory Review teams to find… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy adjustments and improve execution Health Systems Strategy Support o Collaborate with medical affairs and market access teams to support the execution of ... you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development… more
- Eisai, Inc (Nutley, NJ)
- …execution of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These ... be used in external interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be ... scientific support for research activities, publications, education, consulting, and other Medical Affairs initiatives. The MSL will provide credible, compliant,… 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). ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Merck & Co. (North Wales, PA)
- …The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates ... national immunization technical advisory groups.Responsibilities and Primary ActivitiesPartners with Medical Affairs counterparts to develop, execute and deliver… more
- Leica Biosystems (Miami, FL)
- …make an impact.Learn about the Danaher Business System which makes everything possible.The Senior Principal, Regulatory Affairs is responsible for ... Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and… more
- Merck & Co. (Rahway, NJ)
- …The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. ... Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Communication, Data Management, Medical Affairs , Parasitology, People Management, Pharmacoeconomics, Researching,… 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
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …teams in the TA & other TAs, cross-functional teams, including sales, marketing, medical affairs , market access and policy/advocacy (MAPA), Centers of Excellence ... (COEs), regulatory affairs , other relevant NNI departments, and...industry required Proven knowledge of the pharmaceutical industry, including medical , regulatory , clinical processes and market dynamics,… more
- Merck & Co. (North Wales, PA)
- …The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Merck & Co. (North Wales, PA)
- …with Product Development Teams, Franchise Teams, Regional Product Directors, affiliates, Public Affairs , and Medical Education to ensure value evidence programs ... strategies and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement… more
