North AmericaFull TimeOther
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Job Description
📋 Description
- Lead and write clinical and regulatory documents for drug/device development to support AbbVie
- Work with moderate autonomy on drafts, with review from SMEs and senior writers for verification.
- Coordinate review, approval, and QA of contributors; conduct team review meetings.
- Produce and maintain clinical/regulatory documents focusing on quality and timelines; manage
- Develop knowledge of US/international regulations and guidelines for regulatory docs; use related
- Participate in tactical process improvements and resolve issues during the writing process
🎯 Requirements
- A minimum of 4+ years in bio-pharmaceutical/global pharma/biotech/healthcare delivering medicines
- Bachelor's Degree or higher; scientific discipline preferred.
- Outstanding written and oral communication with strong scientific terminology across multiple
- Proficient in analyzing complex data; experienced in writing/editing clinical/regulatory documents
- Understanding of drug development, clinical research, study designs, biostatistics, pharmacology
- Excellent writing skills to communicate complex information to stakeholders; strong organizational
🎁 Benefits
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Eligible to participate in short-term incentive programs.
- Company-wide equal opportunity employer; commitment to integrity and innovation.
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