Medical Reviewer

Job description

Medical Reviewer
Cambridge, MA
1 Year Contract
Competitive Pay

The role of the Medical Reviewer involves the oversight and approval of promotional and non-promotional materials to ensure compliance with regulatory standards and internal protocols. This position provides essential scientific insight and direction in line with the ABPI Code of Practice, facilitating the creation, examination, and endorsement of content that supports the responsible and safe usage of pharmaceutical products while fostering active engagement with stakeholders.

Key Responsibilities

• Evaluate and endorse promotional and non-promotional content to ensure alignment with the ABPI Code of Practice.
• Serve as the Appropriately Qualified Professional (AQP) when required.
• Offer scientific assessments and compliance advice throughout the production of medical and marketing materials.
• Collaborate with cross-functional groups (such as Medical Affairs, Marketing, and Regulatory) to enhance the content development and approval workflows.
• Assist in creating and providing training resources concerning compliance and scientific protocols.
• Support regulatory submissions by verifying correctness and compliance with applicable standards.
• Contribute to the formulation and implementation of compliance strategies.
• Handle complaints, inquiries, and internal communications associated with materials and compliance matters.
• Ensure that all materials are factually correct, well-balanced, and underpinned by solid scientific evidence.

Required Skills & Qualifications

• Thorough understanding of the ABPI Code of Practice and associated regulatory requirements.
• Capability to analyze and apply intricate scientific information to material development and review processes.
• Exceptional attention to detail coupled with outstanding organizational abilities.
• Proficient written and verbal communication skills.
• Able to work collaboratively with diverse functional teams.
• Discernment and capacity to make decisions focused on compliance.

Education & Experience

• A Bachelor’s degree in a scientific or healthcare-related discipline is necessary (advanced degree preferred).
• Preferred certification as an Appropriately Qualified Professional (AQP).
• 5–7 years of experience in medical review, regulatory affairs, or similar roles within the pharmaceutical or healthcare sector.