Manager, Medical Information

Responsibilities

• Manage dissemination of medical information correspondence for multiple therapeutic areas to external (healthcare professionals) and internal customers within the pharmaceutical regulatory framework.
• Conduct and critically evaluate literature searches and scientific data.
• Prepare standard response documents; continuously update the standard response letter database.
• Ensure projects complete on schedule per established procedures and timelines.
• Create and review medical summaries of published literature for standard response letters.
• Support and guide responses to a vendor call center, including general training.
• Work within relevant and newly published FDA guidance for medical information.
• Lead and/or contribute to Medical Information planning for new product launches, line extensions, and key data releases.
• Provide logical recommendations and solutions for medical information activities.
• Provide Medical Information support at conference booths and learn booth processes.
• Collaborate cross-functionally with Medical Affairs/Regulatory/Pharmacovigilance as needed.
• Execute AMCP dossier requests with HEOR and field medical teams.
• Assist with ad-hoc Medical Information oversight and project coordination with minimal direction.
• Business travel (~10%) for scientific congresses and/or internal meetings.

• Bachelor’s degree required; advanced degree (PharmD, PhD, etc.) preferred.
• Fellowship in Medical Information or at least 2 years related Medical Information experience in the pharmaceutical industry preferred.
• Excellent verbal, written, and interpersonal skills.
• High attention to detail.
• Strong task management skills (planning, prioritization, objective setting, meeting management) strongly preferred.
• Ability to support management and build effective stakeholder relationships.
• Critical thinking with ability to anticipate issues and impacts.
• Proficiency in Microsoft Excel, PowerPoint, and Word; strong working knowledge of databases.