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ai microsoft office protocols document management systems regulatory writing📋 Description
- Collaborates with cross-functional teams to prepare submission-ready documents.
- Prepares protocols, Investigators' brochures, CSRs, and briefing documents.
- Manages timelines, milestones, and stakeholder communication.
- Maintains templates, style guides, and SOPs for consistency.
- Oversees external vendors/consultants to meet milestones efficiently.
- Uses AI-enabled tools to boost efficiency while ensuring compliance.
🎯 Requirements
- Bachelors in science; 8+ years in medical writing.
- Ability to analyze data and summarize results clearly.
- Strong interpersonal and communication skills.
- Excellent organizational skills; manage multiple priorities.
- Experience authoring scientific documents and supervising third parties.
- Proficient in Microsoft Office, DMS, and reference software; quick to learn tools.
🎁 Benefits
- Great culture grounded in C.O.R.E. values.
- Fast-paced environment with multi-hat roles.
- Competitive compensation and benefits package.
- Generous PTO and company-wide shutdowns.
- Support for professional development and growth.
- All-team in-person meetings to build relationships.
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