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 to support company goals.

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

• Draft materials with a moderate level of autonomy while integrating feedback from subject matter experts and senior writers.

• Cultivate knowledge and comprehension of submission strategies.

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

• Organize and conduct team review meetings.

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

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

• Apply both US and international regulations, requirements, and guidelines to regulatory documentation.

• Engage in tactical process improvements.

• Identify and propose solutions to challenges encountered during the writing process, resolving issues or escalating as necessary.

• Collaborate with leadership and R&D Quality Assurance to address inquiries and draft responses in support of an inspection-ready approach.

⛳️ Requirements

• A minimum of 4+ years of experience in the bio-pharmaceutical industry, particularly in global pharma, biotech, life sciences, or healthcare authorities delivering medicines/therapies across various therapeutic areas.

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

• Exceptional written and oral communication skills.

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

• Proficient in assimilating and analyzing complex data.

• Experience in writing and editing clinical and regulatory documents in accordance with guidelines and regulations, including ICH guidelines, GCP, and other regulatory requirements.

• Familiarity with CONSORT and PRISMA guidelines.

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

• Experience in writing for EU and US devices is advantageous.

• Excellent writing abilities.

• Capability to communicate complex scientific and medical information to diverse stakeholders.

• Ability to manage multiple projects simultaneously and collaborate effectively with cross-functional teams.

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

• Capacity to sit continuously for extended periods, exceeding 2 consecutive hours in an 8-hour workday.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility for participation in long-term incentive programs.