Principal Strategic Medical Writer

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

📋 Description

• Oversee and create clinical and regulatory documentation for drug and/or device development.

• Independently generate clinical and regulatory documents necessary for AbbVie’s drug and device initiatives.

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

• Organize and lead team review meetings.

• Collaborate with teams on document creation and content strategies.

• Communicate project deliverables, writing processes, and timelines effectively.

• Hold team members accountable for meeting agreed-upon project deadlines.

• Contribute to project management strategies and guide team members towards achieving submission goals.

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

• Develop a thorough understanding of US and international regulations and guidance pertaining to regulatory documentation.

• Identify and suggest solutions for challenges encountered during the writing process.

• Utilize therapeutic area and product knowledge for scientific and business enhancement projects.

• Work autonomously with R&D Quality Assurance on inquiries and draft responses while ensuring inspection readiness.

⛳️ Requirements

• At least 5+ years of experience in the bio-pharmaceutical industry within a global pharmaceutical, biotech, life sciences, or healthcare authority.

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

• Exceptional written and verbal communication skills.

• In-depth knowledge of medical and scientific terminology across various therapeutic areas.

• Proficient in assimilating and analyzing complex data.

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

• Superior writing abilities.

• Capability to convey complex scientific and medical information to diverse stakeholders.

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

• Strong organizational, time management, and problem-solving skills.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility to participate in long-term incentive programs.