Senior Manager, Medical Information

Role Summary

Senior Manager, Medical Information, reporting to the Associate Director, Scientific Communications, is responsible for ensuring the quality and medical accuracy of promotional and non-promotional materials. This role represents Medical Affairs in a cross-functional review committee, working closely with Medical, Regulatory, and Legal functions to ensure scientific balance, medical accuracy, and scientific validity of materials. It will also support the development, maintenance, and dissemination of standard and custom Medical Information response letters and other Medical Information materials.

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 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

Qualifications

• Required: PharmD, PhD, MS, BS, or other clinically oriented healthcare-related degree with appropriate experience
• Required: 2+ years of experience in working in a Medical Review role in the pharma industry
• Required: 2+ years of experience in scientific/medical literature identification and evaluation
• Required: 1+ years of experience in medical writing
• Preferred: Experience with Microsoft products and familiarity with Veeva Vault
• Preferred: Solid tumor oncology experience
• Preferred: Product launch experience

Skills

• Knowledge of FDA regulations relevant to drug promotion and dissemination for medical and product information
• Effective oral, written, and interpersonal skills, ability to work with a wide range of individuals
• Ability to adapt, organize, prioritize, and work effectively independently as well as within cross-functional teams
• Detail-oriented
• Proven problem-solving and conflict resolution skills