Nuvalent, Inc.
#PreciselyTargetedTherapies for patients with cancer
Senior Manager, Medical Information
Location
Massachusetts
Posted
44 days ago
Salary
$150K - $170K / year
Bachelor Degree2 yrs expEnglishVault
Job Description
• Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
• Determine if promotional messages and medical statements are appropriately supported by data
• Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
• Remain current on regulations and best practices within the industry
• Maintain ongoing communication with Medical Leads to ensure materials are aligned to medical strategy
• Demonstrate knowledge of disease area, product labeling, and regulatory guidance
• Maintain therapeutic area and product knowledge through ongoing assessment of relevant literature, treatment guidelines, and internal and external data sources
• Conduct literature searches in order to ensure that the most current and appropriate literature is cited in the materials
• Support the development and updates of Medical Information Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and other Medical Information materials in order to ensure complete, accurate, balanced, and referenced materials are available to respond to unsolicited requests for scientific information in a timely manner
• Support the development and updates of scientific Medical Affairs materials (e.g., decks, clinical trial flyers, medical exhibit materials, etc.)
• Support the development of regulatory compliance processes, including training documents, standard operating procedures, work instructions and other supporting process documents
• Support completion of quality review of medical information cases and, as necessary, ensure correction and provide feedback/retraining
• Support handling of inquiries escalated to the internal Medical Information department by providing timely responses to unsolicited inquiries
• Assist in recognizing, collecting, and ensuring the appropriate forwarding of safety/adverse event and/or product quality information according to FDA guidelines and company policies
• Attend external medical conferences and staff the Medical Affairs booth as needed
Job Requirements
- PharmD, PhD, MS, BS, or other clinically oriented healthcare-related degree with appropriate experience
- 2+ years of experience in working in a Medical Review role in the pharma industry
- 2+ years of experience in scientific/medical literature identification and evaluation
- 1+ years of experience in medical writing
- Experience with Microsoft products and familiarity with Veeva Vault preferred
- Solid tumor oncology experience preferred
- Product launch experience preferred
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
- comprehensive benefit package to support employees
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