Senior Strategic Medical Writer

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

📋 Description

• Lead the creation and writing of clinical and regulatory documents for drug and/or device development.

• Prepare essential clinical and regulatory documents necessary for AbbVie’s drug and device development processes.

• Cultivate an understanding of submission strategies.

• Coordinate the review, approval, and quality control processes across various functions.

• Organize and facilitate team review meetings.

• Produce and uphold high-quality, compliant clinical and regulatory documents within the specified project timelines.

• Assume increased responsibility for achieving submission objectives.

• Implement US and international regulations, requirements, and guidelines in regulatory documentation.

• Engage in tactical process enhancements.

• Identify challenges during the writing process and propose effective solutions.

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

⛳️ Requirements

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

• A 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 a variety of therapeutic areas.

• Skilled in assimilating and analyzing complex data.

• 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.

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

• Excellent writing capabilities.

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

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

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

🏝️ Benefits

• Paid time off, which includes vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Options for remote work.