- 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. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… 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. (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
- 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. (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
- 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)
- …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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Customer Call Center, Enterprise Insights, Supply Chain, Procurement, Public Affairs , Public Policy, Regulatory , Legal, IT, Trade, Patient Safety ... Responsible for the compilation and processing of pharmacy redemptions for Senior Management approval Oversees vendor performance via regular status meetings,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... communication and stakeholder management skills, with ability to influence senior leaders and collaborate with cross-functional teams across the organization… more
- CorDx (Atlanta, GA)
- …some of the most critical questions in healthcare. Job Type: Full time Job Title: Senior Regulatory Affairs Manager Location: Onsite - Atlanta, or San Diego ... Position Summary: The Senior Regulatory Affairs Manager will...degree preferred. Minimum of 7-10 years of experience in regulatory affairs within the medical … more
