Senior Strategic Medical Writer

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

📋 Description

• Oversee and compose clinical and regulatory documentation for drug and/or device development.

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

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

• Cultivate an understanding of submission strategies.

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

• Organize and conduct team review meetings.

• Create and maintain clinical and regulatory documents, prioritizing quality, compliance, and adherence to project timelines.

• Enhance knowledge of project management concepts and take on increased responsibility for achieving submission goals.

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

• Engage in tactical process enhancements.

• Identify and propose solutions for challenges arising during the writing process, addressing or escalating issues as necessary.

• Collaborate with leadership and R&D Quality Assurance to respond to inquiries and draft appropriate responses, ensuring readiness for inspections.

• Remain seated continuously for extended durations, exceeding 2 consecutive hours within an 8-hour workday.

⛳️ Requirements

• Minimum of 4 years of experience in the bio-pharmaceutical industry within global pharma, biotech, life sciences, or healthcare authority settings.

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

• Exceptional written and verbal communication abilities.

• Extensive knowledge of medical and scientific terminology across various therapeutic areas.

• Proficient 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.

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

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

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

• Experience in EU and US device writing is an advantage.

🏝️ Benefits

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

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in short-term incentive programs.