Senior Strategic Medical Writer

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

📋 Description

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

• Create the necessary clinical and regulatory documentation for the advancement of AbbVie drugs and/or devices.

• Draft materials with a degree of independence and integrate feedback from subject matter experts and senior writers.

• Cultivate knowledge and insight into submission strategies.

• Manage the review, approval, and quality assurance across various functions involved in clinical and regulatory initiatives.

• Organize and facilitate team review meetings.

• Generate and uphold clinical and regulatory documents with an emphasis on quality, compliance, and adherence to project timelines.

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

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

• Engage in tactical enhancements of processes.

• Recognize and suggest solutions to issues within the writing process, resolving or escalating as necessary.

• Collaborate with leadership and R&D Quality Assurance to handle inquiries and draft responses that support an inspection-ready stance.

⛳️ Requirements

• 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 abilities.

• Thorough understanding of medical and scientific terminology across various therapeutic fields.

• Skilled in assimilating and interpreting complex data.

• Proven experience in writing and editing clinical and regulatory documents in accordance with ICH guidelines, GCP, and other regulatory requirements.

• Familiarity with CONSORT and PRISMA guidelines.

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

• Superior writing capabilities.

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

• Competence in managing multiple projects concurrently and collaborating with cross-functional teams.

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility for short-term incentive programs.

• Remote work options available.