Title: Manager, Medical Information
Reports to: Associate Director, Medical Information
General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for responding to inquiries from Health Care Providers about marketed and investigational compounds.
Roles and Responsibilities
- Supports day to day operations of Medical Information Services function at Sage
- Responsible for the Creation and maintenance of MI documents and ensures that information is scientifically accurate, timely, balanced, and meet customers’ needs
- Manages medical information responses and materials through the internal medical, legal and regulatory review process
- Responsible for tracking responses to medical information requests from internal and external customers through the MI Response Center vendor
- Responsible for ensuring that the documentation of the MI inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
- Monitors adverse events and product quality complaints and processes in accordance with company SOPs
- Assists in the creation of metric reports on key business processes to monitor Medical Information services
- Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
- Perform critical analysis and synthesis of internal/external literature related to Sage products and therapeutic areas of focus
- Exhibits broad knowledge of assigned therapeutic areas, product labelling and regulatory guidance
- Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental documents and processes.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
- Minimum of 2 years Medical Information experience with 5+ years in the pharmaceutical/ biotechnology industry
- Understanding of and adherence to regulatory policies governing scientific interactions with physicians
- Experience working with vendors on a day-to-day basis
- Experience with data management and informatics;
- Excellent written and oral communication skills;
- Prior industry experience in a post-marketing setting
- U.S. Launch experience; Orphan, CNS, and / or acute care preferred
- Ability to quickly understand and communicate all clinical data / publications to support business objectives
- Demonstrated abilities to prioritize and manage multiple projects, and effectively influence, collaborate, and communicate with internal and external partners
- An outstanding track record of strong communication, presentation, analytic and strategic capabilities
- This position requires US and international travel, approximately 10 – 25%
- Excitement about the vision and mission of Sage.
- Ability to thrive in a fast-paced, entrepreneurial, results oriented environment with busy, high performing colleagues.
- Demonstrated ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
- Must be able to take an undefined objective and leading the process through to operational excellence.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun