- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and ... execution of scientific & medical affairs plans for Ophthalmology). They build...global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) engages… more
- Merck & Co. (Rahway, NJ)
- …Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You ... design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of… more
- Merck & Co. (Rahway, NJ)
- …breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical ... Research Group. Under the guidance of a supervisor, the Director has primary responsibility for the planning and directing of clinical research activities involving… 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 ... needs to support collaboration to further differentiate our portfolio.The Oncology Regional Medical Scientific Director , RMSD, is a credentialed (ie, MD, PhD,… more
- Merck & Co. (Rahway, NJ)
- …cooperative relationships with a diverse range of stakeholders, including medical researchers, veterinarians, project managers, and regulatory affairs ... Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting… more
- Merck & Co. (Rahway, NJ)
- …Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to manage ... applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global… more
- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.--The Director (Principal Scientist) has primary responsibility for the planning and ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including: study… more
- Genmab (Plainsboro, NJ)
- …to be our 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… 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 ... research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial site identification, ongoing… 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 ... industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience with ex-US labeling… 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 ... technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help… 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 ... Years in the pharmaceutical industry preferred1 or More Years in regulatory affairs requiredExperience in (s)NDA/BLA filing to FDA preferred Travel Ability to travel… 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 ... and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist...ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory… 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 ... technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, ... 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 ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… 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 ... diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an… 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