- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary: The Global Senior Director Medical Affairs (Sr GDMA), Hematology is responsible for driving the development and execution of the ... years Hematology and Oncology experienceAt least 3 years regional medical affairs experience (eg, Regional Director...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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Responsibilities- Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical ... through to later stages of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and… more
- Merck & Co. (Rahway, NJ)
- …project management skills Preferred Experience and Skills: At least 5 years global or US medical affairs or clinical development experience with proven track ... Executive Director , Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable...in certain states and cities within the United States . Final determinations with respect to… more
- Merck & Co. (Rahway, NJ)
- Job Description Role Summary: JOB DESCRIPTION: The Regional Director Medical Affairs (RDMA) is responsible for driving execution of scientific & medical ... plan for head and neck cancer.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
- 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 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)
- …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 ... 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic regulatory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion.… 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 ... for the development of global (and US ) regulatory strategies (depending on the assigned project/projects) to...to the Team Lead of Regulatory Strategy, Global Regulatory Affairs , the key responsibilities include but are not limited… more
- Merck & Co. (Rahway, NJ)
- …the salary range for this job in certain states and cities within the United States . Final determinations with respect to salary will take into account a ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …auditors in conjunction with CCQM, compliance, Regulatory,-Pharmacovigilance (PV) and Medical Affairs .Responsible and supports development of audit responses ... Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in...in certain states and cities within the United States . Final determinations with respect to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and adoption/uptake of standards and best practices for PED throughout the US organization. Relationships The Director -Patient Centered Outcomes Research reports ... development, CMR is involved. The one thing that keeps us all marching to the same beat is our...Medical and Regulatory (CMR), Market Access and Public Affairs (MAPA), as well as collaborating where appropriate with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …representatives. Interacts internally with team representatives from PCOR, Finance, Brands, Medical Affairs , HEOR, Commercial Pipeline, Field Sales, Account ... Value Communications, Strategy & Portfolio Innovation, PCOR, Brands, Health Economics, Medical Affairs , Account Executives, Analytics, and Global Pricing to… more
