Senior Manager, Medical Affairs

Job Function Summary

This position is member of the clinical science & office of medical affairs team. It is responsible for managing the medical affairs teams for Men’s Health and Women’s Health, as well as driving and managing clinical documentation to support marketing and regulatory needs, development and implementation of departmental processes & procedures. This position will oversee the Men’s Health and Women’s Health medical affairs staff, and will delegate tasks to the clinical team members according to project plan. This position will comply with regulations and ensure clinical science & OMA activities comply with organizational SOPs and global regulatory requirements.

Major Areas of Accountability

• Manage medical affairs team in respective business areas, i.e., Men’s Health and Women’s Health
• Develop and implement global medical affairs strategy for Men’s Health and Women’s Health
• Organize and participate in medical communications strategy to support the commercial organization, in collaboration with the marketing function
• Oversee the publication strategy and implementation, including management of publication activities, as applicable
• Lead and implement global clinical data strategy to support claims
• Oversee the strategic planning and execution of required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and SSCPs
• Collaborate with the Clinical Operations team regarding planning, conduct and reporting of clinical trials in accordance with the Clinical Documentation Plan
• Serve as medical affairs expert at relevant external clinical trial forums, at congresses and similar external meetings (e.g. lnvestigator meetings)
• Oversee development of Clinical Evaluation Reports (CERs) and associated documents
• Oversee development and maintenance of the Master Harms list for relevant product categories
• Oversee standard procedure process development, maintenance, and improvement, including adjacent processes such as clinical support for complaint handling, globally
• Drive publications of data to ensure relevant content at medical congresses and at Coloplast events
• Drive the development and implementation of the process for receiving and responding to literature, off-label, and other scientific inquiries
• Develop and oversee project plans and budgets
• Act as clinical representative on cross-functional product development team, including evaluation of clinical risk
• Develop/sustain knowledge in urology, including professional conference attendance
• Support Investigator Initiated Study Program (IISP) as assigned
• Support to medical marketing activities (strategy for evidence dissemination, KOL engagements, planning of symposia, review/validation of communications)
• Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
• Report critical issues confronting the clinical strategies/clinical trials and preparation of corrective actions plans that have been put in place to address those critical issues
• Participate in meetings with Authorities (MHRA; DGM; FDA) for regutatory approval of the products with regard to the clinical documentation
• Develop business cases for additional medical affairs resources, as required
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned

Basic Qualifications

• 7+ years’ experience within clinical research, preferably with medical devices
• Bachelor’s degree (preferably in health science or biotech area). Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD).
• Knowledge of and experience meetings with ISO, FDA, GCP, and MedDev regulations and guidance for trial related activities.
• Experience developing and writing SOPs
• Ability to travel - 20-30%