General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for leading the Medical Information Services for all Sage Therapeutics marketed products and investigational compounds.
Roles and Responsibilities
- Provides management, vision and strategic direction for Medical Information Services
- Responsible for the development/enhancement and implementation of policies, procedures, and processes for Medical Information Services
- Responsible for prompt and accurate responses to medical information requests from internal and external customers through the MI Response Center, email, fax and websites
- Review and approval of outbound responses and contact center FAQs
- Responsible for management and training of medical information (vendor) 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
- Accountable for the creation, review and maintenance of MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
- Develop/maintain metrics on key business processes to monitor Medical Information services
- Ensures that the documentation of the inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
- Ensures that adverse events and product quality complaints are processed in accordance with company SOPs
- Exhibits broad knowledge of assigned therapeutic areas and a solid understanding of pertinent disease state(s)
- Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental annual strategic documents.
Experience, Education and Specialized Knowledge and Skills
- Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
- Minimum of 8 years Medical Information experience with 6+ 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 (5 years+);
- Excellent written and oral communication skills;
- Prior industry experience in a post-marketing setting (2 years+)
- U.S. Launch experience required
- 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
- Note this position requires US and international travel (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