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
• Define priorities and ensure milestones are achieved for all initiatives. Communicate regularly with stakeholders on project progress and risks to achieving milestones

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%
• 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.

Preferred Qualifications

• Clinical or Advanced degree in a technical discipline (e.g., scientific, clinical or engineering)

• Knowledge of US clinical practices related to patient care for intermittent catheterization, ostomy and/or bowel management in patients with neurogenic bladder and/or bowel
• Experience with digital data collection and analysis of patient reported outcomes

Required Knowledge, Skills, and Abilities:

• Strong ability to review and interpret evidence and outcomes 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
• High degree of initiative and self-motivation with a strong sense of accountability
• Ability to identify, analyze and solve problems and propose a solution
• 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

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 and inclusive work environment where everyone feels valued, and diversity is celebrated. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Employee Resource Groups that support Women, Minorities, Veterans and LGBTQ+ Community. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $128,529 to $192,793. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.