The Quality Medical Reviewer role in Medical Affairs is to review and approve U.S. medical (non-promotional) and promotional materials to ensure they are medically accurate and interpreted correctly based on the review of references/citations and data available. The role involves providing scientific and clinical inputs while collaborating with cross-functional teams during the review and approval of content.
Primary Responsibilities:
- Know Lilly’s policies and procedures, and review promotional and medical (non-promotional) materials
- Apply Lilly’s quality requirements and processes (i.e., CIQ and MCA requirements) consistently during the review process
- Verify all data values match the source documentation and are consistently used throughout document sections, charts, legends, and footnotes
- Ensure visual representations of data accurately convey the meaning/results of the data
- Ensure data represents current knowledge and published scientific data
- Ensure information is presented clearly, completely, accurately, and concisely
- Ensure key data, statements, and conclusions are consistent across related documents, and are integrated, accurate, balanced, and supported by appropriate data
- Collaborate with cross-functional teams such as Marketing, Medical teams, etc., during the review, approval, and management of content
- Demonstrate working knowledge of therapeutic areas, products, and disease state information
- Expertise in tools and platforms such as Veeva Vault, project planning software (e.g., Wrike, MS Project), etc.
- Understand and actively address questions related to clinical/medical/scientific content from cross-functional teams in a timely fashion
- Participate in the development and review of promotional and medical content in collaboration with brand teams, regulatory, copyeditors, etc.
- Responsible and accountable for the oversight and delivery of tasks
- Uphold Lilly procedures and processes
- Review and approve materials in a timely manner
- Determine corrective actions to eliminate recurring issues
- Liaise with CIQ/MCA Lead and Operations teams in tracking and managing deviations
- Partner effectively with cross-functional colleagues and facilitate shared-learning forums to establish best practices and identify challenges across teams
- Offer scientific and medical input, and contribute to the development, review, and approval of promotional and medical materials
- Adhere to best practices based on Lilly’s internal standards
Minimum Qualification Requirements:
- 2-4 years of experience working as a scientific/medical editor, copywriter, copyeditor, or in promotional and medical (non-promotional) content for publishing, marketing, communications, advertising agency, or pharmaceutical industry
- Good understanding of scientific/medical/statistical terminologies
- Demonstrated initiative and ability to influence, collaborate, and work on cross-functional teams
- Ability to make decisions within the scope of responsibility
- Demonstrated ability to prioritize and handle multiple concurrent tasks with strong attention to detail, critical thinking, and analytical ability
- Excellent written and verbal communication skills
- Ability to work well independently or as part of a team, within and across culturally and geographically diverse environments
- Experience working in a regulated industry (e.g., pharma)
Additional Preferences:
- In-depth familiarity with the US CIQ/MCA framework, procedures, processes, and tools like Veeva Vault, Wrike, etc.
- Experience in reviewing/writing Medical Affairs communications (slide decks, patient or HCP materials, etc.)
- Knowledge and experience specific to clinical pharmacology, therapeutic areas such as neuroscience, oncology, cardiovascular, immunology or endocrinology, or other medical and scientific fields
