Medical Affairs Program Manager

The Medical Affairs Program Manager is responsible for supporting evidence strategies and for executing Coloplast agenda in the clinical community.

 

The Chronic Care business at Coloplast has products to help patients with intimate healthcare needs. The patient population spans spinal cord injury, cancer, Multiple Sclerosis, spina bifida, and many more.

 

The candidate will do this by covering a broad range of medical affairs activities, such as:

• Driving acceptance of Coloplast product claims through publications and strategic evidence dissemination
• Developing evidence roadmaps consisting of surveys, pre-clinical and clinical data, patient reported outcomes, case studies, consensus studies, literature reviews, opinion papers etc. with the goal of improving the guidelines
• Generating new evidence, such as observational studies, registries, case studies, consensus and opinion papers, etc.
• Interpretating published and new evidence, summarizing it in a form suitable for education of healthcare professionals, payors, and government agencies
• Cultivating relationships with Key Opinion Leaders (KOLs) to shape the clinical agenda resulting in guideline and medical policies enhancement
• Identifying external clinical opinions, perceptions and trends that influence Coloplast performance in the US, where warranted, executing appropriate mitigating strategies

 

Ideal candidates will have a strong ability to translate clinical and real-world evidence into simple but relevant messages, business acumen, KOL influence skills, broad knowledge of evidence dissemination and marketing claims substantiation practices used in the medical device industry in the US.

Major Areas of Accountability

• Partner with US and global cross functional teams to identify business priorities and lead evidence strategy development 
• Leverage literature, regulations, and guidelines to build and execute on evidence strategies
• Drive execution of new evidence, including study design, data collection and interpretation as well as publications to ensure relevant content is presented at medical congresses and at Coloplast events
• Partner with global cross functional teams, including Medical Affairs to identify research and publication opportunities using new and existing data
• Develop and maintain KOL network able to support Coloplast evidence generation, advocacy, and education needs
• Support preparation for Coloplast meetings with government agencies, such as FDA, CMS, etc. and commercial payors by providing medical expertise, leveraging KOL networks, preparing evidence summaries and presentations
• Inform and shape outcomes of medical advisory boards as applicable
• Provide medical expertise for novel ideas, questions and information requests related to Chronic Care products
• Monitor trends and share new clinical evidence that address unmet needs (i.e. improved clinical, financial or patient satisfaction outcomes) substantiated through medical congresses, expert networks and library searches
• 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 job duties as assigned

 

Additional Responsibilities

• • • Strong understanding of Coloplast products and therapies, relevant anatomy, and accepted applications and uses associated with our products
    • Financial budget modeling and scenario planning around evidence needs
    • Monitoring project progress for timely intervention and problem solving
    • Understanding of the compliance requirements, best practices accepted in the market and competitive space

 

Basic Qualifications

• Bachelor’s degree in a technical discipline (e.g., medicine, science, nursing)
• 8+ years’ experience working in a medical device or health policy
• 3+ years of clinical or outcomes research experience
• International and domestic travel required up to 25%

 

Preferred Qualifications

• Clinical or Advanced degree in a technical discipl