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Medical Affairs Program Manager

4 weeks ago

Minneapolis, Minnesota, United States Coloplast Full time
Job Title:

Medical Affairs Program Manager

Job Summary:

We are seeking a highly skilled Medical Affairs Program Manager to join our Clinical Science and Office of Medical Affairs team. The successful candidate will be responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and providing clinical expertise as required.

Key Responsibilities:
  • Define near, medium, and long-term objectives covering a broad range of medical affairs activities
  • Drive acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence
  • Identify external clinical opinions, perceptions, and trends that influence Coloplast performance globally, and develop appropriate mitigating strategies
  • Execute the scientific agenda by engaging researchers through Coloplast activities and grants and other evidence generation activities
  • Support the development of regulatory or quality-associated documentation
Requirements:
  • 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
About Coloplast:

Coloplast is a leading medical device company that develops and markets products and services that make life easier for people with intimate healthcare needs. We are committed to a policy of Equal Employment Opportunity and employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.