Medical Information Director

Our clinical stage pharmaceutical client here in Boston, MA is growing and looking to add a Medical Information Director to their Chief Medical Office (REMOTE). This role will be a key member of the Medical Affairs leadership team contributing with both subject matter expertise on the disease/product as well as up to date knowledge on Medical Information & Material review best practices. Key activities for the role include the building of Medical Information and Compliance as a function, developing high quality MI content based on current standards, ensuring the implementation of the Medical Materials review and approval process, partnering with commercial colleagues in creating scientifically accurate and compliant material, developing training material, supporting congress presence etc. Responsibilities include but not limited to:

• Develop strong product and disease expertise and maintain knowledge base
• Build Medical Information related tools and processes
• Responsible for building and maintaining a knowledge base including among others customized and standard response documents, FAQs etc.
• Ensure responses to unsolicited enquiries are delivered in a timely manner and are developed based on highest scientific and process standards
• Coordinate review of Medical Information documents
• Maintain relevant electronic tools and platforms
• Develop training material (e.g. literature alerts) and offer training to internal teams as needed
• Establish the development of metric reports/dashboards on a regular basis and present as needed
• Support congress presence by capturing MI queries, developing congress specific FAQs, scientific intelligence, booth staffing etc.
• Build strong cross-functional working relationships (clinical development, pharmacovigilance etc.)
• Leads the Medical Materials Review Process and ensures relevant material comply to industry and other standards
• Serve as medical reviewer for medical and promotional material
• Collaborate with commercial in building scientifically accurate, compelling and compliant with current standards promotional campaigns
• Maintains up to date knowledge of FDA guidance and standards as well as relevant to Company geographies
• Manage budget and vendors

Requirements:

• Advanced scientific degree (PharmD, Ph.D.) AND 8 years of experience in Medical Affairs of which at least 4 in Medical Information
• Excellent working knowledge of Global rules and regulations governing Medical Information and Review
• Experience in vaccines is a plus
• Ability to manage time and resources effectively

Other:

• Up to 20% - Congress related