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
Seniority level
Director
Employment type
Full-time
Job function
Science
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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