
Medical Affairs Manager
Posted Jul 31

Posted Jul 31
This is a fully remote position, open to applicants in Minnesota.
• Assisting in the development of evidence strategies and implementing the Coloplast agenda within the clinical community.
• Promoting acceptance of Coloplast product claims through publications and strategic dissemination of evidence.
• Creating evidence roadmaps that include surveys, pre-clinical and clinical data, patient-reported outcomes, case studies, consensus studies, literature reviews, opinion papers, and more.
• Producing new evidence through observational studies, registries, case studies, consensus papers, and opinion articles.
• Analyzing both published and new evidence, summarizing it in formats suitable for educating healthcare professionals, payors, and government entities.
• Building relationships with Key Opinion Leaders (KOLs) to influence the clinical agenda, leading to enhancements in guidelines and medical policies.
• Recognizing external clinical opinions, perceptions, and trends that affect Coloplast's performance in the U.S., and implementing necessary strategies when needed.
• Collaborating with U.S. and global cross-functional teams to determine business priorities and spearhead evidence strategy development.
• Utilizing literature, regulations, and guidelines to construct and implement evidence strategies.
• Overseeing the execution of new evidence, including study design, data collection, interpretation, and publications to ensure pertinent content is presented at medical congresses and Coloplast events.
• Assisting in preparations for meetings with government agencies, such as the FDA and CMS, and commercial payors by providing medical expertise, leveraging KOL networks, and preparing evidence summaries and presentations.
• Influencing and shaping the outcomes of medical advisory boards as necessary.
• Tracking trends and sharing new clinical evidence that addresses unmet needs (e.g., improved clinical, financial, or patient satisfaction outcomes), validated through medical congresses, expert networks, and library searches.
• Bachelor’s degree in a technical field (e.g., medicine, science, nursing).
• Over 8 years of experience in the medical device or health policy sectors.
• At least 3 years of experience in clinical or outcomes research.
• Familiarity with U.S. clinical practices concerning patient care for intermittent catheterization, ostomy, and/or bowel management in patients with neurogenic bladder and/or bowel issues.
• Experience in digital data collection and analysis of patient-reported outcomes.
• Strong capability to review and interpret evidence and outcomes research.
• Proven track record of working collaboratively across functions to prioritize and achieve strategic goals.
• Exceptional oral and written communication skills.
• Strong project management and organizational abilities.
• High levels of initiative and self-motivation, coupled with a strong sense of accountability.
• Ability to identify, analyze, and resolve problems while proposing effective solutions.
• Skill in prioritizing and managing multiple tasks while meeting deadlines.
• Flexibility to quickly realign initiatives to adapt to market changes.
• Proficiency in Microsoft Word, Excel, and PowerPoint is required.
• Comprehensive medical, dental, and vision insurance plans to ensure the health of you and your family.
• Access to company-sponsored wellness programs and mental health resources.
• Paid leave of absence for qualifying events.
• Generous paid parental leave for both birthing and non-birthing parents.
• A competitive 401(k) plan with immediate company match.
• Financial planning services to assist in securing your future.
• Corporate discount programs for various goods and services.
• Generous paid time off.
• Flexible work hours.
• Options for flexible work arrangements to help balance your personal and professional life.
• Opportunities for ongoing learning and career advancement through training, mentorship, and tuition reimbursement.
• Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• A supportive work environment where everyone feels valued and has a sense of belonging.
• Participation in team-building activities, volunteer opportunities, and company-sponsored events.
• A sustainability strategy that outlines our ambitions for operating our company in a more sustainable manner.
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