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Senior Scientific Documentation Specialist
1 month ago
Join Lilly's team of experts as a Senior Scientific Documentation Specialist, where you will be responsible for the timely completion and coordination of scientific documents in accordance with company and project priorities. Your role will involve independently writing and editing development, qualification, and regulatory submission documents, as well as reviewing contributions for consistency.
Key Responsibilities:
- Coordinate the work of multiple writers contributing to projects, and review contributions for consistency.
- Write and edit development, qualification, and regulatory submission documents in accordance with company and project priorities.
- Support literature review and writing projects within the Medicines Innovation Hub organization.
- Perform data integrity review of documents to ensure data accuracy and retrievability.
- Stays abreast of relevant new and current regulatory expectations, guidelines, and requirements for submission documents.
Requirements:
- Minimum of a Bachelor's degree in English language, health-related science field or scientific writing with 2 years of relevant experience.
- Familiarity with FDA regulations, ICH guidelines, and other relevant regulations.
- Ability to interpret articles in scientific literature, laboratory reports, study protocols, and other documents.