Medical Affairs Specialist

This position is member of the clinical science & office of medical affairs team. This role is responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and provide clinical expertise as required. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.

Major Areas of Accountability

• Serve as medical expert for relevant product(s) and associated clinical conditions
• Support the required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and other relevant documents
• Support development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned (i.e. CER, PMCF, SSCP, PSUR, etc)
• Develop and deliver medical device technical documents supporting product launch and sustaining activities
• Act as clinical representative on cross-functional product development team
• Develop and deliver relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activities
• Supports with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.). Manage publication activities, as applicable
• Develop/sustain knowledge in urology, including professional conference attendance
• Support Investigator Initiated Study Program (IISP) as assigned
• Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
• Support to medical marketing activities (KOL engagements, symposia, review/validation of communications)
• Participate in benefit/risk ratio assessment for vigilance and Risk Management Files
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned

Basic Qualifications

• 5+ years’ experience within clinical research and/or medical affairs activities, preferably with medical devices
• Bachelor’s degree (health science or biotech area). Advanced degree in the health sciences preferred (MS, PhD, PharmD, MD)
• Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
• Ability to travel - 20-30%