Senior Strategic Medical Writer - Remote

📋 Description

• Prepare clinical and regulatory documents for AbbVie drugs/devices.
• Autonomy on drafts with review by SMEs and senior writers.
• Coordinate review/approval and QA of regulatory projects.
• Produce regulatory docs with focus on quality and timelines.
• Learn submission strategies for US/international regs.
• Contribute to tactical process improvements.

🎯 Requirements

• 4+ years bio-pharma industry experience in global pharma/biotech.
• Bachelor's degree or higher; scientific discipline preferred.
• Excellent written and oral communication; strong medical terminology.
• Proficient in analyzing complex data.
• Experience writing/editing clinical/regulatory docs (ICH, GCP); EU/US device writing a plus.
• Understanding of drug development, study designs, biostatistics, regulatory requirements.

🎁 Benefits

• Competitive benefits including PTO, medical/dental/vision and 401(k).
• Eligible for short-term incentive programs.
• AbbVie is an equal opportunity employer.