Senior Manager, Medical Affairs

Location: 

Minneapolis, MN, US

Job Family:  Research & Development
Country/Region:  United States
 

This position is member of the clinical science & office of medical affairs team. is the role 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. In addition, this role will support the overarching Medical Affairs strategy for MH and WH products to ensure full product lifecycle support, including commercial activities of the organization. This position will oversee the Men’s Health and Women’s Health medical affairs staff and will delegate tasks to the 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 medical conference activities strategy and content development, including symposia and other associated events. Serve as medical affairs expert at relevant external clinical trial forums, at congresses and similar external meetings (e.g. lnvestigator meetings)
  • 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, as well as FDA annual reports
  • Collaborate with the Clinical Operations team regarding planning, conduct and reporting of clinical trials
  • Oversee development and execution of vigilance activities such as medical safety assessment, clinical risk/benefit analysis, medical assessment of complaints, and medical advisement of Master Harms list and associated documents 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, including abstract, manuscripts and conference symposia content, 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 medical affairs representative on cross-functional product development team(s), including but not limited to evaluation of clinical risk/benefit
  • Develop/sustain knowledge in urology, including professional conference attendance
  • Support Investigator Initiated Study Program (IISP) as assigned
  • Support to commercial and professional education 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.
  • Participate in meetings with Authorities (MHRA; DGM; FDA) for regulatory approval of the products with regard to the clinical documentation, as required
  • Develop business cases for medical affairs projects and additional medical affairs resources, as required
  • Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
  • Other duties as assigned

 

 

Basic Qualifications

  • 8+ years’ experience within medical affairs and/or clinical science, 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)
  • 3+ years’ experience managing a medical affairs and/or clinical science teams
  • Knowledge of and experience with ISO, FDA, GCP, EU MDR and MedDev regulations
  • Experience in strategy development, project management, and budget oversight
  • Ability to travel - 20-30%

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things.

 

Visit us on Coloplast.com.

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Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we 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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Nearest Major Market: Minneapolis