Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.
Primary Responsibilities:
- EMS (Executive Medical Summary) Content Strategy and Execution:
- Collect and evaluate data from multiple sources to create cohesive content.
- Plan, write, edit, review, and complete regulatory documents.
- Ensure data clarity, accuracy, and consistency across documents.
- Coordinate expert reviews and prepare final document versions.
- Perform quality checks for accuracy.
- Project and Stakeholder Management:
- Lead the writing process and apply effective project management skills.
- Build and communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery.
- Communicate project status to stakeholders.
- Knowledge and Skills Development:
- Maintain and enhance therapeutic area knowledge.
- Adapt to various document types, therapeutic areas, and compounds.
- Stay updated on regulatory and publication guidelines.
- Contribute to clinical planning and submission strategy.
- Knowledge Sharing:
- Provide coaching and share technical information.
- Network to identify and share best practices.
- Contribute to process improvements.
- Provide expertise in database and document management systems.
Minimum Qualification Requirements:
- Bachelor’s degree in a scientific, health, communications, technology, or health-related field.
- Demonstrated experience in technical/regulatory scientific writing.
- Strong communication and interpersonal skills.
- Successful completion of a writing exercise (required as part of the evaluation process).
Additional Preferences:
- Graduate degree with a formal research component or in life sciences.
- Mastery of verbal and written English skills in medical, scientific, or technical writing.
- Specific knowledge in clinical pharmacology, therapeutic areas (e.g., neuroscience, oncology, cardiovascular, immunology, endocrine).
- Experience writing regulatory, clinical trial documents, and/or publications.
- Experience in clinical development, clinical trial process, or regulatory activities.
- Strong project management and time management skills.
- High-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation templates).
