Position: Regulatory Writer
Company: Eli Lilly
Location: Bengaluru
Salary: ₹5.10 LPA
Experience: 1 to 2 Years
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
About Company:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work globally to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
Primary Responsibilities:
Content Strategy and Execution:
- Document preparation, development, and finalization/management
- Collect and evaluate data from multiple sources
- Plan, write, edit, review, and complete regulatory documents
- Conduct document initiation meetings
- Build scientific-based rationale for complex documents
- Ensure data is presented clearly, accurately, and concisely
- Coordinate expert/scientific reviews and prepare final versions
- Perform quality checks for accuracy
- Manage multiple document types with flexibility
- Develop presentations with experts
- Manage relationships with vendors/alliance partners
Project and Stakeholder Management:
- Lead the writing process with effective project management skills
- Build and communicate credible project timelines
- Anticipate and mitigate risks to delivery
- Ensure smooth development of documents, escalating issues as necessary
- Communicate project status to stakeholders effectively
Knowledge and Skills Development:
- Maintain and enhance knowledge of therapeutic areas
- Stay updated on regulatory and publication guidelines
- Broad understanding of compounds, therapeutic areas, and external environment
- Enhance scientific communication skills
Knowledge Sharing:
- Provide coaching and technical guidance
- Network to identify and share best practices
- Contribute to process improvements
- Provide expertise in databases and document management systems
Key Requirements:
Minimum Qualification Requirements:
- Bachelor’s degree in a scientific, health, communications, or technology-related field
- Experience in technical/regulatory scientific writing
- Strong communication and interpersonal skills
- Successful completion of a writing exercise
Additional Preferences:
- Graduate degree with formal research component or in life sciences
- Mastery of English in medical, scientific, or technical writing
- Experience in clinical pharmacology, therapeutic areas, or other medical fields
- Experience in writing regulatory, clinical trial documents, and/or publications
- Experience in clinical development, trial processes, or regulatory activities
- Strong project and time management skills
- High-level computer skills (e.g., word processing, spreadsheets, presentations)
How to Apply:
Interested candidates meeting the above criteria are encouraged to apply through our website or send their resume to email@example.com.