Senior Strategic Medical Writer

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

📋 Description

• Lead and create clinical and regulatory documents for the development of drugs and/or devices.

• Prepare the necessary clinical and regulatory documentation for AbbVie’s drugs and devices.

• Develop knowledge of submission strategies and support objectives related to submissions.

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

• Organize and conduct team review meetings.

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

• Enhance project management skills and take on greater responsibility for achieving submission goals.

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

• Engage in tactical process enhancements.

• Identify and suggest solutions for issues that arise during the writing process, addressing or escalating as necessary.

• Collaborate with leadership and R&D Quality Assurance to respond to inquiries and draft responses for inspection preparedness.

• Remain seated for extended periods exceeding two consecutive hours in an eight-hour workday.

⛳️ Requirements

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

• 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 diverse therapeutic areas.

• Proficient in assimilating and analyzing complex data.

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

• Familiarity with CONSORT and PRISMA guidelines.

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

• Excellent writing capabilities.

• Ability to convey complex scientific and medical information to various stakeholders effectively.

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

• Strong 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.