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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
Job Responsibility:
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 plan, 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
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 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
Requirements:
5+ years’ experience within clinical research and/or medical affairs activities, preferably with medical devices
Bachelor’s degree (health science or biotech area)
Knowledge of and experience with ISO 14155, FDA, GCP, and MDR regulations
Ability to travel - 10%
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
What we offer:
Comprehensive medical, dental, and vision insurance plans
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
competitive 401(k) plan with company match that vest immediately
financial planning services
corporate discount programs for goods and services
generous paid time off
flexible work hours
flexible work arrangement options
opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
supportive work environment
team-building activities, volunteer opportunities, and company-sponsored events