Medical Affairs Program Manager

This position is a 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 providing clinical expertise as required. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.

They will do this by defining near, medium and long-term objectives covering a broad range of medical affairs activities, such as:

• Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence
• Identifying external clinical opinions, perceptions and trends that influence Coloplast performance globally, and where warranted, develop appropriate mitigating strategies
• Executing the scientific agenda, by engaging researchers through Coloplast activities and grants and other evidence generation activities
• Supporting the development of any regulatory or quality associated documentation

Major Areas of Accountability

• Serve as medical expert for relevant product(s) and associated clinical conditions
• Oversee the medical affairs strategy development and implementation for designated area(s)
• 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
• Leverage 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 (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)
• Ensure timelines and milestones are achieved for all initiatives. 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
• Provides medical expertise for novel ideas, questions and information requests related to Interventional Urology products
• Facilitates medical advisory boards as applicable
• Ensures resources/time spent is 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

• Maintains 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 - 20-30%