Senior Strategic Medical Writer

🔥 1 minute ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Prepares clinical and regulatory documents needed for the development of AbbVie drugs and/or devices. • Functions with a moderate degree of autonomy on draft materials, but relies on review by subject matter experts and more senior writers for verification. • Develops knowledge and understanding of submission strategies. • Coordinates the review, approval, and quality control of other functions involved in the production of clinical and regulatory projects. • Arranges and conducts review meetings with the team. • Produces and maintains clinical and regulatory documents focusing on quality and compliance and ensures delivery within project timelines. • Develops understanding of project management concepts and accepts greater responsibility for driving submission objectives. • Develops knowledge of US and international regulations, requirements, and guidelines pertaining to the preparation of regulatory documentation. • Understands and uses guidance associated with preparation of regulatory documentation. • Participates in execution of tactical process improvements. • Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate. • Works 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 bio-pharmaceutical industry experience in global pharma, biotech, life science, or healthcare authority delivering medicines/therapies to a broad market across various therapeutic areas. • Bachelor's Degree or higher required; scientific discipline preferred. • Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas. • Proficient in assimilating and analyzing complex data. • Experience writing and editing clinical and regulatory documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. • Familiarity with industry standards like CONSORT and PRISMA guidelines. • EU and US device writing experience is a plus. • Understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors • Excellent writing skills. • Effectively communicates complex scientific and medical information to various stakeholders. • Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. • Strong organizational, time management, and problem-solving skills.

🏖️ Benefits

• paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) to eligible employees • long-term incentive programs