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