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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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Name :

Regulatory Writer

Organization :

Eli Lilly

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

1 to 2 Years

Salary:

CTC: 5.10 LPA

Location:

Bengaluru

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. The purpose of the Scientific Communications Associate – Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences.

Primary Responsibilities:

  1. Content Strategy and Execution: Document Preparation, Development, and Finalization/Document Management
    • Collect and evaluate data from multiple sources to create a cohesive content strategy.
    • Plan, write, edit, review, and complete regulatory documents supporting clinical development/product registration.
    • Conduct document initiation meetings to ensure team alignment.
    • Build scientific-based rationale supporting complex documents.
    • Ensure data are presented clearly, completely, accurately, and concisely.
    • Ensure consistency across related documents.
    • Coordinate expert/scientific reviews and prepare final versions.
    • Perform quality checks for accuracy.
    • Exhibit flexibility in managing multiple document types.
    • Influence or negotiate changes in timelines and content with team members.
    • Develop and prepare presentations with internal and external experts.
    • Manage relationships with vendors/alliance partners as needed.
  2. Project and Stakeholder Management
    • Lead the writing process using effective project management skills to ensure timely completion of high-quality documents.
    • Build and communicate credible project timelines.
    • Anticipate and mitigate risks to delivery.
    • Ensure smooth and timely development of documents, escalating issues as necessary.
    • Effectively communicate project status to stakeholders.
  3. Knowledge and Skills Development
    • Maintain and enhance knowledge of therapeutic areas, including disease states and compounds.
    • Exhibit flexibility in handling various document types and therapeutic areas.
    • Stay updated on regulatory and publication guidelines.
    • Maintain a broad understanding of the compound, therapeutic area, and external environment.
    • Enhance scientific communication skills to meet audience needs and adapt to technological changes.
  4. Knowledge Sharing
    • Provide coaching by sharing technical information and guidance.
    • Network with others to identify and share best practices.
    • Contribute to process improvements.
    • Provide expertise in databases and document management systems.

Minimum Qualification Requirements:

  • Bachelor’s degree in a scientific, health, communications, or technology-related field.
  • Demonstrated 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 verbal and written English skills in medical, scientific, or technical writing.
  • Specific knowledge and experience in clinical pharmacology, therapeutic areas, or other medical and scientific fields.
  • Experience in writing regulatory, clinical trial documents, and/or publications.
  • Experience in clinical development, clinical trial processes, or regulatory activities.
  • Strong project management and time management skills.
  • High-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).

Application Link