Senior Strategic Medical Writer

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

📋 Description

• Take the lead in crafting clinical and regulatory documents for the development of drugs and/or devices.

• Prepare essential clinical and regulatory documentation required for AbbVie's drug and device development efforts.

• Draft materials with a reasonable degree of autonomy and seek reviews from subject matter experts and senior writers.

• Cultivate an 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.

• Produce and uphold high-quality, compliant clinical and regulatory documents within set project timelines.

• Assume increased responsibility for achieving submission goals and implement project management principles.

• Acquire knowledge of US and international regulations, requirements, and guidelines.

• Engage in tactical process enhancements.

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

• Collaborate with leadership and R&D Quality Assurance to address inquiries and draft appropriate responses.

• Support a readiness for inspections.

• Maintain a seated position continuously for extended periods, exceeding 2 consecutive hours within an 8-hour workday.

⛳️ Requirements

• A minimum of 4 years of experience in the bio-pharmaceutical industry, encompassing global pharma, biotech, life sciences, or healthcare authorities.

• A Bachelor's Degree or higher is required, preferably in a scientific discipline.

• Exceptional written and verbal communication skills.

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

• Skilled in assimilating and analyzing intricate 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.

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

• Excellent writing capabilities.

• Capacity to convey complex scientific and medical information to diverse stakeholders.

• Ability to manage multiple projects concurrently and work collaboratively with cross-functional teams.

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for remote work.

• Equal opportunity employer.

• Reasonable accommodations available for applicants in the US and Puerto Rico.