- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as lead for CRM (customer relationship management) system supporting NNI Medical Affairs . Assumes functional ownership and partners with line of business and IT ... IT and NNI Veeva CRM teams to shape solutions aligned to medical affairs priorities. Develop and maintain operational procedures and standards in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and ... particular focus on obesity and obesity-related metabolic disorders. - The Senior Director will manage the entire cycle of clinical development, including study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Government Affairs & US Corp Giving & Social Impact. External relationships include relations with patient/caregiver consultants and, key opinion leaders (KOLs), ... Managers, and Market Access), Brand Marketing, Training, Market Access & Public Affairs , Trade, Legal, Compliance, Finance, HEOR, and Market Research. The position… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing Real-World Evidence ... objectives, in alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead for research within a specific therapeutic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility as well as ... partner with Field Sales, Market Access, Commercial Excellence, Medical Affairs , Strategic Partnerships and Engagement, Customer Experience and Marketing Enablement,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an ... to Senior Leaders in the Line of Business. In this role, the Director will demonstrate exceptional ability to proactively partner with and appropriately influence… 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
- Merck & Co. (Rahway, NJ)
- …the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, ... applying rigorous scientific and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PCOR (Pricing, Contracting, Operations and Reimbursement), Marketing, Commercial Sales, Medical Affairs , Legal & Compliance and Human Resources. External ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Merck & Co. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. 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
- 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
