Medical Affairs Program Manager
| Coloplast has an exciting opportunity for a Medical Affairs Program Manager to join our growing team!
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 Bowel Management Products. The Chronic Care business at Coloplast has 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 defining 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 clinical program design, including value-based healthcare initiatives
- Supporting the development and execution of the clinical roadmap associated with the value proposition for Coloplast’s Bowel Management products
- Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence, 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 scientific agenda in the US, by engaging researchers through Coloplast activities and grants, including where appropriate, conducting clinical studies that lead to publications in support of Coloplast business objectives
Ideal candidates will have both strong clinical research, including real-world evidence analysis, and commercial understanding. The ideal candidate has clinical background in medical/scientific affairs from within the medical device industry or similar (either pharma or biotech industries).
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| Major Areas of Accountability |
- Support medical affairs activities including representation of the US clinical perspective on global innovation projects, market access, regulatory and commercial activities
- Lead clinical strategy development and execution for Bowel Management Products.
- Drive execution of clinical research strategy, including design, implementation and analysis
- Monitor trends and discovering and sharing 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
- 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.
- Partner with cross functional teams to create and execute a clinical program (CARE) clinical publication plan supporting the Coloplast value proposition to external stakeholders in the US
- 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, and accepted applications and uses associated with our products
- Financial budget modeling and scenario planning around evidence needs
- 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
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| Basic Qualifications |
- Master’s or Doctoral Degree in a technical discipline (e.g., medicine, science, nursing)
- 5+ years’ experience working in a medical device or pharma industry with a Masters or 3+ years with a Doctoral degree
- 2+ years of clinical research experience
- International and domestic travel required up to 25%
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| Preferred Qualifications |
- Clinical or Advanced degree (e.g., RN, NP, PA, PhD, MD, MPH) in a technical discipline (e.g., scientific, clinical or engineering)
- Knowledge of US clinical practices related to patient care for intermittent catheterization, ostomy and bowel management in patients with neurogenic bladder and/or bowel
- Understanding of reimbursement and the relationship of payors and evidence
- Experience with digital data collection and analysis of patient reported outcomes
Required 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
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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
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Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.
