Regulatory Scientific Writer

2 weeks ago


Bengaluru, Karnataka, India Lilly Full time

 

Job Title: Regulatory Scientific Writer

 

Job Summary:

We are seeking a highly skilled Regulatory Scientific Writer to join our Medical Affairs team at Lilly. As a Regulatory Scientific Writer, you will be responsible for developing high-quality, regulatory-grade documents that support the development and approval of pharmaceutical products.

Responsibilities:

  1. Develop and maintain a deep understanding of regulatory guidelines and requirements for pharmaceutical products.
  2. Collaborate with cross-functional teams to gather data, information, and input from multiple sources to create cohesive content strategies for writing projects.
  3. Plan, write, edit, review, and finalize regulatory documents, including clinical trials, product labels, and other regulatory submissions.
  4. Conduct document initiation meetings to ensure authoring team alignment and understanding.
  5. Build scientific-based rationales that support the purpose of complex documents.
  6. Ensure data is presented in a clear, complete, accurate, and concise manner.
  7. Coordinate expert/scientific reviews, collate reviewer comments, adjust content as required, and prepare final versions.
  8. Ensure and coordinate quality checks for accuracy.

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.

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