- Merck & Co. (Rahway, NJ)
- Job Description Role Summary: The Regional Director Medical Affairs (RDMA) is responsible for driving execution of scientific & medical affairs plans ... plan for their assigned TA Chairs the Regional Medical Affairs Team to ensure execution of...in certain states and cities within the United States . Final determinations with respect to… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical affairs leadership for assigned asset(s)/indications and… more
- Insmed Incorporated (New York, NY)
- …to ensure adequate training, access to educational resources and alignment between Insmed's medical affairs plans and the unmet needs of the patients and ... 2024, we became Great Place to Work-certified in the US for the fourth year in a row. We...development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring ... communication, and networking skillsMust possess a thorough understanding of the United States Federal Drug Administration (FDA), Office of Inspector… more
- Merck & Co. (Rahway, NJ)
- …stakeholder communication tools in collaboration with Commercial, R&D, Outcomes Research, Medical Affairs , Policy, Communications, and with regional and local ... and Product Development Teams (PDTs), (ex. clinical, OR and medical affairs ), regional and country teams to...in certain states and cities within the United States . Final determinations with respect to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Regulatory Affairs - Regulatory Project Management (RPM) provides ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...planning and drives coordination of global and US regulatory activities. The Associate Director RPM… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ex- ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and transparent ways of working across the Alliance within US regulatory affairs and will work closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... into the Oncology drug development preferred.Ability to interpret and understand US regulations governing the pharmaceutical industry; general global knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs , NDA, sNDA, BLA filing to FDA Travel Ability to travel up to 30%… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Serve as lead for CRM (customer relationship management) system supporting NNI Medical Affairs . Assumes functional ownership and partners with line of ... NNI Veeva CRM teams to shape solutions aligned to medical affairs priorities. Develop and maintain operational...SOPs and guidelines. Relationships This position reports to the Director , Medical Omnichannel Technology Solutions and is… more
- Tris Pharma (Monmouth Junction, NJ)
- …leadership of a small MSL team. Collaborating closely with, and reporting directly to, VP/ Medical Affairs in developing medical strategic and tactical plans ... team success.We have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , ...Adverse Events (AEs) and Product Quality Complaints (PQCs)Collaborates with VP/ Medical Affairs to ascertain and secure resources… more
- Tris Pharma (Monmouth Junction, NJ)
- …and compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, etc.)Collaborates ... Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines… more
- Genmab (Plainsboro, NJ)
- …Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM Genmab US , IT Lead in Japan)Peers within IT&D, such as ... will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US...and IT&D leaders, with a main focus in the United States .IT&D Partner: Acts as security partner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory, and commercial, to facilitate the integration ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...of stakeholders across CDSE and more broadly within Clinical, Medical and Regulatory, Market Access and Public Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience ... pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experienceExperience with ex- US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...the business functions of Daiichi Sankyo (DS) in the US , EU, Japan, and other global sites. These business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including CCDS and US /EU labeling experience ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
