Medical Affairs Medical Reviewer - Consultant

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for ensuring the medical and scientific integrity of external communications. The position will represent Medical Affairs in a cross-functional team and will provide scientific review of medical affairs content and branded/promotional materials. The successful candidate will have an established track record of cultivating partnerships with team members, including individuals within Medical Strategy, Clinical Development, Patient Advocacy, Regulatory, Legal, and Marketing teams.

Roles and Responsibilities

• Serve as a member of the internal Medical, Legal, Regulatory review board.

  • Develop strong relationships with key internal stakeholders to provide direction at the initiation, creation, and review of educational and promotional materials.

  • Critically review and approve of promotional and medical materials in compliance with corporate standards and government/industry regulations to ensure medical accuracy, objectivity, and fair-balance.

  • Determine if data/references used are appropriate to support strategy and tactics and provide strong guidance as well as effective negotiation leading to resolution for pieces.

  • Remain current on regulations, best practices, and current trends within the industry and share learnings with others across the review teams.

  • Act as the Medical Reviewer function to ensure best practices are executed to increase the quality and scientific rigor of all Field Commercial and Medical materials.

  • Advise cross-functional teams on how to best communicate the scientific/medical value of products to key internal and external audiences.

  • Demonstrate broad knowledge of disease areas, product labeling, and regulatory guidance.

  • Conduct literature searches in order to ensure the most current and appropriate literature is cited in the materials and to maintain product expertise.

  • Ensure alignment of external medical communication tools with broader disease state and compound communication strategy.

  • May participate in ad hoc projects.

• Engage with brand medical directors to maintain alignment with Medical Affairs communication strategy for marketed and pipeline compounds.

• Collaborate with the Preclinical, Clinical Development, and Medical Affairs teams to identify key developments in the understanding of mood disorders and Sage’s pipeline compounds.

• 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.

• Exhibit broad knowledge of assigned therapeutic areas, product labelling, and regulatory guidance.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills and the ability to develop important relationships with key stakeholders, including effective conflict management and negotiation skills.

Basic Qualifications

• MD, DO, or PhD/PharmD required.

• 5+ years of prior industry experience, preferably in psychiatry/mood disorders.

• 3-5+ years of combined pharmaceutical industry and/or academic/clinical medicine expertise, including working knowledge of FDA regulations relevant to drug promotion and dissemination for medical and product information.

Preferred Qualifications

• Previous experience in scientific communications or medical information preferred.

• Relevant therapeutic background desired (Psychiatry).

• Ability to analyze and communicate reviewer recommendations and offer alternative approaches to project owners.

• Experience in Veeva systems.

• Proficient in MS Office applications.

• Customer focus: dedicated to meeting the expectations and requirements of internal and external customers.

• Ability to manage many complex projects in parallel, structuring the actions of many people toward share outcomes.

• Ability to work independently and as a team player.

• Be result-oriented with a proven track record of success.

• Must demonstrate flexibility in response to changing needs and competing demands.

• Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority.

• Must be highly perceptive, socially intelligent, and intuitive.

• Able to perceive non-obvious opportunities by connecting the dots between existing knowledge, new data, and HCP unmet needs in real-time.

• Must embrace Sage’s core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.