Senior Strategic Medical Writer

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

📋 Description

• Prepares clinical and regulatory documents essential for the development of AbbVie drugs and/or devices.

• Operates with a moderate level of independence on draft materials, but depends on reviews by subject matter experts and senior writers for validation.

• Cultivates knowledge and comprehension of submission strategies.

• Coordinates the review, approval, and quality control processes involving other functions in the execution of clinical and regulatory projects.

• Organizes and conducts review meetings with the team.

• Generates and maintains clinical and regulatory documents with a focus on quality and compliance, ensuring timely delivery within project schedules.

• Gains understanding of project management principles and takes on greater responsibility for achieving submission goals.

• Acquires knowledge of US and international regulations, requirements, and guidelines relevant to the preparation of regulatory documentation.

• Understands and applies guidance related to the preparation of regulatory documents.

• Engages in the execution of tactical process enhancements.

• Identifies and suggests solutions to address issues and inquiries that arise during the writing process, including appropriate resolution or escalation.

• Collaborates closely with leadership and R&D Quality Assurance to address inquiries and draft responses, supporting an inspection-ready approach.

⛳️ Requirements

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

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

• Exceptional written and verbal communication skills, with a thorough understanding of medical and scientific terminology across multiple therapeutic areas.

• Adept at assimilating and analyzing complex data.

• Proven experience in writing and editing clinical and regulatory documents in accordance with guidelines and regulations, such as ICH guidelines, GCP, and other regulatory standards.

• Familiarity with industry standards such as CONSORT and PRISMA guidelines.

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

• Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors.

• Excellent writing capabilities.

• Effectively communicates intricate scientific and medical information to diverse stakeholders.

• Ability to manage multiple projects concurrently and collaborate 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 available to eligible employees.

• Long-term incentive programs.