Contractor, Manager, Medical Review, Medical Affairs

Our Waltham based pharmaceutical client is seeking a Manager, Medical Review, Medical Affairs to join their growing team. The incumbent will be responsible for providing the medical and scientific accuracy review of promotional and non-promotional materials across the portfolio. As necessary, this individual may support broader activities within Medical Affairs. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements.

Key Responsibilities:

· Ensure medical accuracy of Company’s advertising, promotional and scientific materials as part of Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with the Medical Information Lead and Medical Directors

· Responsible for fact-checking of data points and verifying that all claims and statements are adequately supported by appropriate references and properly cited in materials submitted to the PMRC/MMRC.

· Partner with cross-functional PMRC/MMRC team to ensure compliance with regulatory, compliance and corporate standards in all materials
• Attend and participate in cross-functional PMRC and MMRC meetings.
• Perform reviews in a timely manner by the requested due date

· Provides support to Medical Communications initiatives as needed.

Qualifications:

· Bachelor of Science degree in relevant scientific or medical field required. Advanced degree (Master’s or Doctorate) preferred.

· 1- 3 years of experience in pharmaceutical/biotech industry-based medical information/medical review or related discipline

· Excellent written, verbal, and interpersonal communication skills

· Must be a strong team player with the ability to effectively collaborate with cross-functional team

· Superior literature database search skills

· Proficiency with Microsoft Office suite

· Detailed-oriented with strong ability to work independently

· Excellent organizational, time management, and prioritization skills

· Prior experience working with promotional/medical review systems (e.g., Veeva PromoMats)

· Adept at learning new software / applications

· Prior experience in rare disease, oncology, or related therapeutic area is preferred