Bachelor's degree in health science, engineering, or biotech; advanced degree preferred (MS, PhD, PharmD, MD)
5+ years of experience in clinical research or medical affairs, ideally with medical devices
Familiarity with ISO 14155, FDA, GCP, and MDR regulations
Strong ability to interpret scientific data and communicate findings
Proficiency in Microsoft Word, Excel, and PowerPoint
Responsibilities
Drive acceptance of product claims through clinical evidence generation
Identify clinical trends and develop strategies to address them
Engage researchers and manage scientific agendas
Support development of regulatory and quality documentation
Manage publication activities and ensure timely project milestones
Facilitate medical advisory boards and KOL engagements
Maintain knowledge in urology and attend relevant conferences
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with immediate company match
Generous paid time off and flexible work arrangements
Opportunities for professional development and tuition reimbursement
Recognition programs for employee achievements
Supportive work environment with team-building and volunteer opportunities
Full Job Description
This position is a member of the Clinical Science & Office of Medical Affairs team. This role is responsible for driving and managing clinical documentation to support marketing and regulatory needs, supporting innovation and sustaining product activities, and providing clinical expertise as required. This position will comply with regulations and ensure clinical science & OMA activities comply with global regulatory requirements.
They will do this by defining near, medium and long-term objectives covering a broad range of medical affairs activities, such as:
Driving acceptance of Coloplast product claims in the clinical community through the generation of clinical evidence
Identifying external clinical opinions, perceptions and trends that influence Coloplast performance globally, and where warranted, develop appropriate mitigating strategies
Executing the scientific agenda, by engaging researchers through Coloplast activities and grants and other evidence generation activities
Supporting the development of any regulatory or quality associated documentation
Major Areas of Accountability
Serve as medical expert for relevant product(s) and associated clinical conditions
Oversee the medical affairs strategy development and implementation for designated area(s)
Support the required clinical input into documents including, but not limited to, instructions for use (IFUs), post-market clinical plans (PMCF), clinical evaluation reports (CERs), and other relevant documents
Support development and updates of Clinical Evaluation Reports (CERs) and associated documents as assigned (i.e. CER, PMCF, SSCP, PSUR, etc.)
Develop and deliver medical device technical documents supporting product launch and sustaining activities
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.
Develop and deliver relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activities
Supports with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plans, etc.).
Manage publication activities, as applicable
Develop/sustain knowledge in urology, including professional conference attendance
Support Investigator Initiated Study Program (IISP) as assigned
Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines.
Support to medical marketing activities (KOL engagements, symposia, review/validation of communications)
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
Provides medical expertise for novel ideas, questions and information requests related to Interventional Urology products
Facilitates medical advisory boards and field-based KOL engagements as applicable
Ensures resources/time spent is in line with project prioritization
Participate in benefit/risk ratio assessment for vigilance and Risk Management Files
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
Other duties as assigned
Basic Qualifications
Bachelor's degree in health science, engineering, or biotech area. Advanced degree in the health or engineering sciences preferred (MS, PhD, PharmD, MD)
5+ years' experience within clinical research and/or medical affairs activities, preferably with medical devices
Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
Ability to travel - 15-25%
Required Knowledge, Skills and Abilities
Strong ability to review and interpret scientific data and research and translate it for use cross-functionally
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 engineering, 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
Additional Responsibilities
Maintains strong understanding of product knowledge, relevant anatomy, and 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 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 work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. 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 $108,000 - $150,000. 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.
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About Coloplast Corp
Coloplast Corp is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care. The company was founded in 1957 and is headquartered in Humlebaek, Denmark. Coloplast operates globally with production facilities in Denmark, Hungary, China, and the United States. The company's products are sold in more than 140 countries. Coloplast is committed to improving the quality of life for people who have intimate healthcare needs. The company's mission is to make life easier for people with intimate healthcare needs by developing products and services that make a difference to their lives.
