Associate Director, Medical Information

- Mid Level

Hybrid - Cambridge, MA

Chemical Manufacturing

About the position

This newly created position is responsible for supporting the Medical Information Services (MIS) function at Blueprint Medicines. This person will play a significant role in the launch of our products in US and international markets, as well as be responsible for review and approval of documents for internal and external use as part of the Legal, Medical, and Regulatory review process. The ideal candidate will also have experience in managing an outsourced medical information call center and medical writing to support creation of standard response letters.

Responsibilities

• Support day to day Medical Information operations and participate in cross-functional teams (such as Medical and Commercial reviews and medical strategy meetings).
• Serve as the Medical representative on the Medical Affairs and Promotional Review Committees.
• Oversee external partners, including the Global Medical Information call center, to execute on agreed-upon tactics and projects.
• Managing development and internal review of medical information resource documents, including Standard Response Letters (SRLs).
• Respond to escalated inquiries from medical information call center in a timely manner.
• Participate in the development of the cross-functional Medical Affairs Strategic Plan and ensure ongoing alignment of MIS activities with the plan.
• Ensure documentation of medical information inquiries and responses comply with relevant Standard Operating Procedure (SOP)/ Work Instructions and regulatory guidelines.
• Monitor adverse events and product quality complaints and processes in accordance with Company SOPs and work instructions.
• Training the Medical Information call center specialists on processes and disease state/product information.
• Establish monthly or quarterly (MIS) reports and support the Medical Affairs Operations and Program Management functions in development of relevant reports and dashboards.
• Build and maintain strong working relationships with cross-functional teams and key internal and external stakeholders.
• Liaise with publications, Medical Directors, and clinical development groups to develop and maintain timely and relevant product expertise.
• Collaborate cross-functionally to establish an MIS booth process for scientific congresses and in conjunction with Medical Science Liaisons provide staffing support for the booth and medical congresses.
• Maintain a thorough understanding of disease biology, scientific data, and competitive data in order to develop scientifically rigorous and high-quality products and programs.
• Ensure all MIS activities follow applicable company, governmental, and industry guidelines within any given region.
• Mentor PharmD Medical Affairs fellow and interns, as applicable.

Requirements

• Advanced Clinical/Science degree required (PharmD or PhD preferred)
• 5-7 years of Global Medical Information or related experience

Nice-to-haves

• Rare disease experience preferred
• Veeva Vault experience preferred
• Demonstrated strong interpersonal and communications (verbal and written) skills with both internal and external partners
• Proficient in Microsoft Office and software relevant to medical information function
• Organizational awareness (e.g., inter-departmental relationships, business priorities), including significant experience working cross-functionally and in global teams.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism