Senior Strategic Medical Writer

📋 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.