Principal Strategic Medical Writer

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Oversee and draft clinical and regulatory documents for drug and/or device development.

• Independently create the necessary clinical and regulatory documents for the development of AbbVie drugs and/or devices.

• Facilitate review, approval, and quality control across various functions.

• Organize and lead team review meetings.

• Collaborate with teams on document authorship and content strategies.

• Communicate deliverables, writing processes, and timelines effectively.

• Ensure accountability among team members for agreed-upon project deadlines.

• Contribute to project management strategies and enhance the ability to guide team members towards submission goals.

• Suggest, lead, and/or engage in tactical process improvements.

• Develop in-depth knowledge of US and international regulations and guidelines for regulatory documentation.

• Identify and recommend solutions for challenges encountered during the writing process, including resolution or escalation.

• Utilize therapeutic-area and product knowledge to support scientific and business improvement projects.

• Work autonomously with R&D Quality Assurance to address inquiries and draft responses while maintaining an inspection-ready approach.

⛳️ Requirements

• A minimum of 5 years of experience in the bio-pharmaceutical industry, specifically within a global pharma, biotech, life sciences, or healthcare authority.

• A Bachelor's Degree or higher is required; a background in a scientific discipline is preferred.

• Exceptional written and verbal communication skills.

• Extensive understanding of medical and scientific terminology across various therapeutic areas.

• Skilled in assimilating and analyzing complex data.

• Significant experience in writing and editing clinical and regulatory documents in accordance with ICH guidelines, GCP, and other regulatory standards.

• Familiarity with CONSORT and PRISMA guidelines.

• Advanced knowledge of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.

• Strong writing capabilities.

• Ability to manage multiple projects simultaneously and work collaboratively with cross-functional teams.

• Excellent organizational, time management, and problem-solving abilities.

🏝️ Benefits

• Paid time off including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.