Medical Affairs Program Manager

3 weeks ago

Minneapolis, Minnesota, United States Coloplast Full time
Job Title: Medical Affairs Program Manager

This role is a key member of the Clinical Science & Office of Medical Affairs team at Coloplast. The successful candidate will be responsible for driving and managing clinical documentation to support marketing and regulatory needs, as well as providing clinical expertise as required.

Key Responsibilities:
  • Define near, medium, and long-term objectives for medical affairs activities, including driving 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 mitigating strategies as needed.
  • Execute the scientific agenda by engaging researchers through Coloplast activities and grants, and other evidence generation activities.
  • Support the development of regulatory and quality-associated documentation.
Major Areas of Accountability:
  • Serve as a medical expert for relevant products and associated clinical conditions.
  • Oversee the medical affairs strategy development and implementation for designated areas.
  • Support the required clinical input into documents, including instructions for use, post-market clinical plans, clinical evaluation reports, and other relevant documents.
  • Support the development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned.
  • Develop and deliver medical device technical documents supporting product launch and sustaining activities.
  • Leverage the latest literature, regulations, and guidance to build and execute on evidence strategies.
  • Drive publications of data to ensure relevant content at medical congresses and at Coloplast events.
  • Develop and deliver relevant medical device training documents supporting product launch and sustaining activities.
  • Support medical writing expertise for evidence generation, including white papers, clinical studies, publication plans, and other relevant documents.
  • Manage publication activities as applicable.
  • Develop and sustain knowledge in urology, including professional conference attendance.
  • Support the Investigator Initiated Study Program (IISP) as assigned.
  • Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
  • Support medical marketing activities, including KOL engagements, symposia, review/validation of communications.
  • Ensure timelines and milestones are achieved for all initiatives, and communicate regularly with stakeholders on project progress and risks to achieving milestones.
  • Receive, provide, and track status updates from necessary stakeholders of assigned projects, ensuring alignment.
  • Provide medical expertise for novel ideas, questions, and information requests related to Interventional Urology products.
  • Facilitate medical advisory boards as applicable.
  • Ensure resources/time spent are in line with project prioritization.
  • 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.
Additional Responsibilities:
  • Maintain a strong understanding of product knowledge, relevant anatomy, and accepted applications and uses associated with our products.
  • Develop mechanisms for monitoring project progress for timely intervention and problem-solving.
  • Present to and partner with business leaders on the overall health of the portfolio, successes, and areas of opportunity.
  • Maintain awareness and understanding of the market and competitive space.
Knowledge, Skills, and Abilities:
  • Strong ability to review and interpret scientific data and research.
  • Demonstrated ability to work across functions to prioritize and drive strategic objectives.
  • Excellent oral and written communication skills.
  • Excellent project management and organizational skills.
  • An understanding of biostatistics and trial design.
  • High degree of initiative and self-motivation with a strong sense of accountability.
  • Ability to identify, analyze, and solve problems with minimal direction and make decisions with confidence.
  • Aptitude to successfully prioritize and manage multiple tasks while adhering to deadlines.
  • Adaptability to realign initiatives quickly to meet shifts in the market.
  • Microsoft Word, Excel, PowerPoint proficiency required.
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.

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 (EEO) 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.

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