SUMMARY OF POSITION The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines... applications, amendments, supplements and responses to inquiries from FDA. ORGANIZATION STRUCTURE The Director, Regulatory...
. ORGANIZATION STRUCTURE The Manager, Regulatory Affairs reports into the Director/Associate Director Regulatory Affairs... pharmaceutical industry and a Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred 5 years in...
Job Description Location: New Jersey Job Title: Associated Director Regulatory Affairs Job Responsibilities...; advanced degree desired Minimum of 5 years' experience in Regulatory Affairs and pharmaceutical clinical development...
As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio.... This role will report to the VP/Head of US Medical Affairs and will be responsible for building and leading the USMA team...
, Regulatory, Market Access, Clinical Development, Corporate Affairs, Patient Advocacy and other key cross functional areas... our office three days per week on average. The Sr. Medical Director will lead the development and execution of the medical...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director..., Regulatory Affairs and is based in Morristown, New Jersey. RESPONSIBILITIES Primary responsibilities of this role include the...
activities. ORGANIZATION STRUCTURE The Associate, Regulatory Labeling reports into the Director Labeling and is based in Pine... regulatory affairs. Job-Specific Competencies/Skills: Excellent verbal and written communication skills. Highly motivated...
Director, External Research will enjoy collaborating with Medical Affairs Product Leads on development of the areas of interest...: The Director is accountable for the External Research Program (IITs/CRs) for the Taiho Oncology Inc. (TOI) portfolio in...
to: Senior Director, Commercialization and Enabling Function Data Products Job Type: Full-Time Position Overview: Genmab..., product ownership, and a strong ability to collaborate across multiple teams, including IT, commercial, Medical Affairs...
. The focus of this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs... particular security architects and Genmab Security Operations Team Business leaders (e.g., VP Medical Affairs, VP Regulatory...
, clinical affairs, regulatory, product management and other relevant cross-functional teammates to design and implement evidence... the needs of diverse payer audiences Evidence Generation Collaboration Collaborate closely with medial affairs...
tax, regulatory or compliance implications by working closely with the centralized and local Finance and Legal..., Engineering, and Corporate Affairs This includes sublease and lease termination execution. Meet with the relevant government...
, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit... with practices of and intersections between commercial sales, marketing, medical affairs, and market access organizations in the...
including clinical, product development, regulatory, medical affairs, and other clients on FDA regulator submissions, label... of materials for commercial and medical affairs activities on risk assessments. Contributing to a comprehensive understanding...