Genmab

Operations

• Lead delivery of compliant, submission-ready labeling documents and packaging mockups/artwork for US and EU Centralized Procedure (CP)
• Oversee external vendors and local regulatory consultants delivering timely, compliant labeling for local markets and product maintenance
• Partner with Regulatory, Commercial, Supply Chain, Quality and other stakeholders to lead or oversee mockup/artwork development and submission/launch readiness
• Support development and continuous improvement of global end-to-end labeling processes, tools, systems and infrastructure
• Provide guidance on global labeling requirements and evolving industry standards
• Develop and maintain processes to support RIM document control, lifecycle management and tracking for labeling documents
• Manage vendor delivery of EU CP translations, U.S. Structured Product Labeling (SPL), and other market-specific submission deliverables
• Lead or oversee development of market-specific labeling processes (WIs/SOPs, templates) and manage vendor relationships, contracts, training and budgets
• Contribute labeling input to PSURs, Annual Reports, and other periodic regulatory reports
• Support regulatory intelligence deliverables related to global labeling activities and lead projects like electronic labeling
• Ensure all activities comply with internal SOPs, global regulatory requirements, and GxP standards

Director, Global Labeling, Policy and Intelligence Operations

Medical Director

Support development of individual trial protocols in view of clinical development plan
Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards
Drive and monitor quality of all clinical documents (e.g., protocols, study reports, Investigators’ Brochures, clinical components of regulatory submissions, safety documents)
Support/lead creation/review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] for registration, market access, and commercialization of the compound(s)
Support oversight of the safety of the drug, including the safety aspects of patients in clinical studies and signal detection
Support the development of other relevant medical deliverables: concept sheets, briefing books, and label and marketing application dossier, clinical development plans
Contribute to the development of the program strategy for assigned trials/compounds
Support creation, integration, and execution of overall medical strategy of assigned clinical development programs
Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide input to key external presentations
Support interaction with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel methods of development
Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge

Director, Global Labeling, Policy and Intelligence Operations

Associate Medical Director