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 the development of drugs and/or devices.

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

• Cultivate knowledge and understanding of submission strategies.

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

• Organize and facilitate team review meetings.

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

• Enhance project management skills and assume greater responsibility for achieving submission objectives.

• Acquire knowledge of US and international regulations, requirements, and guidelines related to regulatory documentation.

• Engage in tactical process enhancements.

• Identify and suggest solutions to challenges encountered during the writing process, including resolution or escalation as needed.

• Collaborate with leadership and R&D Quality Assurance to address inquiries and draft responses, ensuring an inspection-ready stance.

• Maintain prolonged sitting for more than two consecutive hours during an eight-hour workday.

⛳️ Requirements

• 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 abilities.

• In-depth knowledge of medical and scientific terminology spanning multiple therapeutic areas.

• Proficient in synthesizing 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 processes, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.

• Strong writing capabilities.

• Ability to convey complex scientific and medical information to a variety of stakeholders.

• Capacity to manage multiple projects concurrently and collaborate effectively with cross-functional teams.

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

🏝️ Benefits

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

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility to participate in short-term incentive programs.