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Teva Medical Writer Mexico, Guanajuato 541640020
29.04.2025
The opportunity
A Medical Writing Associate II, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents. The individual provides basic-level guidance in the production of clinical research documentation used in drug development and product registrations.
How you’ll spend your day
- Primarily works at project level.
- Writes and edits clinical regulatory documents including study reports, protocols, briefing books, and other submission documents (e.g. aggregate reports, post authorization safety studies).
- Compiles, analyzes, and summarizes data from various sources.
- Conducts proofreading, editing, document formatting, and comment resolution.
- Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
- May participate in the preparation/revision of document templates and SOPs.
- May train and support medical writers or external vendors/contractors on document planning, processes, and content development.
Your experience and qualifications
Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field)
University degree with a minimum of 2+ years of relevant experience; advanced degree preferred.
Experience with narratives, aggregate reports, and investigator brochures (IBs).
2+ years with an advanced degree preferred experience authoring protocols, clinical study reports, and submission documents.
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