Senior Manager, Medical Information

Nuvalent, Inc.•Cambridge, MA

23d

About The Position

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Reporting to the Associate Director, Scientific Communications, the Senior Manager, Medical Information will be responsible for ensuring the quality and medical accuracy of promotional and non-promotional materials. This individual will represent Medical Affairs in a cross-functional review committee, working closely with Medical, Regulatory, and Legal functions, and ensure the scientific balance, medical accuracy, and scientific validity of materials. This role will also support the development, maintenance, and dissemination of standard and custom Medical Information response letters, and other Medical Information materials.

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

Responsibilities

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