Senior Strategic Medical Writer

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

📋 Description

• Oversee and compose clinical and regulatory documentation for the development of drugs and/or devices.

• Prepare the necessary clinical and regulatory documents for AbbVie's drug and device development initiatives.

• Create materials with a moderate level of independence and integrate feedback from subject matter experts and senior writers.

• Cultivate an understanding of submission strategies.

• Coordinate the review, approval, and quality control processes across the various functions engaged in clinical and regulatory projects.

• Schedule and facilitate team review meetings.

• Generate and uphold high-quality, compliant clinical and regulatory documents within established project timelines.

• Assume increased responsibility for achieving submission goals while applying project management principles.

• Acquire knowledge of US and international regulations, requirements, and guidelines.

• Engage in tactical process enhancements.

• Recognize and suggest solutions for challenges that emerge during the writing process, addressing or escalating as necessary.

• Collaborate with leadership and R&D Quality Assurance on inquiries and draft responses to ensure readiness for inspections.

⛳️ Requirements

• A minimum of 4 years of experience in the bio-pharmaceutical industry, particularly in global pharma, biotech, life sciences, or healthcare authority settings.

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

• Exceptional written and verbal communication skills.

• Extensive knowledge of medical and scientific terminology across various therapeutic domains.

• Skilled in assimilating and analyzing intricate data.

• Experience in crafting and editing clinical and regulatory documents in accordance with ICH guidelines, GCP, and other regulatory standards.

• Familiarity with CONSORT and PRISMA guidelines.

• Understanding of drug development, clinical research, study design, biostatistics, pharmacology, regulatory requirements, and medical terminology.

• Excellent writing proficiency.

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

• Capability to manage multiple projects at once and collaborate with cross-functional teams.

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

• Required to sit continuously for extended periods (more than 2 consecutive hours within an 8-hour workday).

🏝️ Benefits

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

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for remote work.

• Equal opportunity employer committed to veteran and disability inclusion.