Medical Affairs Program Manager

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The Medical Affairs Program Manager is responsible for driving and executing Coloplast’s agenda in the clinical community with the objectives of driving understanding of and evidence for Coloplast Chronic Care Products. The Chronic Care business at Coloplast has continence, ostomy, and bowel management products to help patients with intimate healthcare needs. The patient population spans spinal cord injury, cancer, Multiple Sclerosis, spina bifida, and many more.

 

S/he will do this by executing near, medium and long-term objectives covering a broad range of medical affairs activities, such as:

• Supporting the development and execution of the clinical roadmap associated with the value proposition for Coloplast’s Chronic Care products
• Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical and patient outcomes data, earning their endorsement and resulting in guideline enhancement
• Identifying external clinical opinions, perceptions and trends that influence Coloplast performance in the US, and where warranted, develop appropriate mitigating strategies
• Executing the clinical agenda in the US, by engaging healthcare providers through various activities, such as case studies, registries, retrospective chart reviews, clinical studies, etc. that lead to publications in support of Coloplast business objectives

 

Ideal candidates will have strong medical writing and evidence interpretation skills, experience in engaging with clinicians, and commercial understanding. The ideal candidate has background in clinical research / medical affairs / medical marketing from within the medical device industry.

 

Major Areas of Accountability

 

• Lead evidence strategy development and execution for Chronic Care Products.
• Drive execution of clinical and outcomes research strategy, including design, implementation and analysis
• Monitor trends discovering and sharing new evidence that addresses unmet needs (i.e. improved clinical, financial or patient satisfaction outcomes)
• 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.
• Support medical affairs activities including representation of the US clinical perspective on global innovation projects, market access, regulatory and commercial activities
• 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
• Ensures resources/time spent is in line with project prioritization

Additional Responsibilities

• Maintains strong understanding of product knowledge, relevant anatomy, disease state and therapy application as well as 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

 

Basic Qualifications

 

• 8+ years’ experience working in a medical device industry
• 5+ years’ of clinical research, medical writing and/or evidence interpretation experience
• International and domestic travel required up to 25%
• 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.