Genetic Counselor, Clinical Reviewer
The Cigna Group
AD/Director, Global Medical Reviewer
Karyopharm Therapeutics Inc.
full-time
Posted on:
Location: Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $170,000 - $240,000 per year
Job Level
Lead
About the role
- Serve as Medical Reviewer in MMRT and CRC, ensuring all medical materials are medically accurate, balanced, scientifically accurate, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
- Optimize MMRT processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
- Collaborate with GMSA, regulatory, legal and commercial teams and utilize Veeva Medcom/PromoMats to review medical/non-promotional and promotional materials in a timely manner
- Work with Medical strategy team and piece owners to contribute to medical content creation, ensuring messaging is accurate
- Collaborate with project owners to resolve comments and ensure compliance
- Attend all scheduled MMRT and CRC meetings as required
- Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
- Work with the MMRT and CRC coordinators to optimize review planning and establish the agenda
- Provide feedback to improve Veeva Medcom review workflows for different material types
- Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
- Perform other duties and responsibilities as assigned
Requirements
- Advanced/doctoral degree (PharmD, PhD) with 7- 8 years of experience in a health/biological science required
- Minimum of 2-3 years of experience in a supervisory/leadership role
- Minimum 5-6 years of experience as a medical communication/ medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
- Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
- Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered emails, etc.), speaker programs, congress exhibits, sales trainings, and internal communications/field direction memos
- Proficiency in technologies for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
- Excellent written and oral communication skills
- Demonstrated ability to analyze, concisely, timely, and accurately summarize, and present complex scientific and medical data to a diverse audience
- A commitment to producing high-level results and performing duties with integrity
- Ability to work independently and within a group setting
- Excellent organizational skills
- Competent in problem solving and sound decision-making
- Strong attention to detail and demonstrable ability to identify and correct errors
- Aptitude for conflict resolution and de-escalation
