Regulatory Writer at Eli Lilly
About Eli Lilly
At Lilly, we unite caring with discovery to make life better for people worldwide. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work to discover and bring life-changing medicines to those in need. We strive to improve disease understanding and management and give back to our communities through philanthropy and volunteerism. Join us if you’re determined to make life better for people around the world.
Position Name
Regulatory Writer
Organization
Eli Lilly
Qualifications
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience
- 1 to 5 Years
Salary
- ₹8.3 Lakhs Per Year
Location
- Bangalore, Karnataka, India
Responsibilities
Content Strategy and Execution:
- Document Preparation, Development, and Finalization/Document Management
- Collect and evaluate data to create a cohesive content strategy.
- Plan, write, edit, review, and complete regulatory documents for clinical development/product registration.
- Conduct effective document initiation meetings.
- Build scientific rationale for complex and strategic documents.
- Ensure clarity, accuracy, and conciseness in data presentation.
- Ensure consistency across related documents.
- Coordinate expert/scientific reviews and prepare the final version.
- Conduct quality checks for accuracy.
- Exhibit flexibility in handling multiple document types.
- Negotiate timeline and content changes with team members.
- Develop and prepare presentations.
- Manage relationships with vendors/alliance partners as needed.
Project and Stakeholder Management:
- Lead the writing process using project management skills.
- Build and communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery.
- Ensure smooth and timely document development.
- Communicate project status to stakeholders effectively.
Knowledge and Skills Development:
- Enhance therapeutic area knowledge, including disease state and compounds.
- Maintain knowledge of regulatory and publication guidelines.
- Stay informed about the compound, therapeutic area, and external environment.
- Participate in clinical planning, submission strategy planning, regulatory responses, and literature updates.
- Enhance scientific communication skills.
Knowledge Sharing:
- Provide coaching and share technical information.
- Recognized for expertise in specific document development.
- Identify and share best practices.
- Contribute to process improvements.
- Provide expertise in database and other tools.
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 a research component or in life sciences.
- Mastery of verbal and written English in medical, scientific, or technical writing.
- Knowledge in clinical pharmacology, therapeutic areas, or medical/scientific fields specific to the hiring area.
- Experience in regulatory, clinical trial documents, and/or publications.
- Experience in clinical development or regulatory activities.
- Project management and time management skills.
- High-level end-user computer skills.
Meta Description
Join Eli Lilly as a Regulatory Writer in Bangalore. Competitive salary and comprehensive benefits. Apply now for a rewarding career.
