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 - 10-20%

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging.  Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for h