- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages with… 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 DescriptionTitle: Director , Global Market Access, Cardiovascular;Our company has an exciting and growing CV, Resp, Metabolic and Neuro pipeline, reinforcing our ... strategies, excellence in pricing strategy and execution, and shaping of the external access landscape. We drive sustainable patient access through innovation in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Responsibilities- Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology ... team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts...Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting ... such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance the efficiency of our clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading, developing and executing US and global communications strategies and ... Associate Vice President, Human Health and Manufacturing Communications, the Executive Director , Global Pharma Communications is responsible for the development of… 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 the ... collaboration to further differentiate our portfolio.The Oncology Regional Medical Scientific Director , RMSD, is a credentialed (ie, MD, PhD, or PharmD) therapeutic… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a part of ... our Global Regulatory Affairs organization.In this role, you will work in close...global environment Skills in building and maintaining internal and external collaborative relationships to achieve shared goals Highly motivated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ... labeling regulations for products and filings. Manages compliance with internal and external guidelines, reviewing US and EU package inserts with regard to both… more
- Genmab (Plainsboro, NJ)
- …experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily responsible ... policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities include but are not limited to: Act… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders.SummaryThe Manager, Global Oncology Medical Affairs (GOMA) Scientific Engagement (SE) is responsible for the execution of ... activities in support of Global Medical Affairs Scientific Engagement strategies and plan for assigned compound(s) and therapeutic areas (TA), under the guidance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease ... of review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback from the regional strategists in terms of HA meetings globally. Responsible… more
- Insmed Incorporated (New York, NY)
- …Medical Science Liaison develops and maintains professional relationships with external healthcare practitioners to provide comprehensive medical and scientific ... adequate training, access to educational resources and alignment between Insmed's medical affairs plans and the unmet needs of the patients and healthcare… 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...as a disease area expert in both internal and external venues including the US/Global cross-functional teams, clinical development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving ... compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination… more
- Genmab (Plainsboro, NJ)
- …be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton, New ... fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.-- The Director (Principal Scientist) has primary responsibility for the planning and directing ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings with CROs, License Partners, and PV ... vendors. Provide PV oversight of the DSI Call Center. Provide oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Director , Patient Centered Outcomes Research, is responsible for the design and execution of ... of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion and subject matter expert within… more
