Principal Strategic Medical Writer

🔥 10 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $109.5k - $208.5k / year

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

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

• Lead and write clinical and regulatory documents for drug and/or device development • Independently prepare clinical and regulatory documents needed for development of AbbVie drugs and/or devices • Coordinate review, approval, and quality control across functions • Arrange and conduct team review meetings • Collaborate with teams on document authoring and content strategies • Communicate deliverables, writing processes, and timelines • Hold team members accountable to agreed-upon project dates • Contribute to project management strategies and develop ability to lead team members toward submission objectives • Recommend, lead, and/or participate in tactical process improvements • Develop expert knowledge of US and international regulations and guidance for regulatory documentation • Identify and propose solutions to issues arising during the writing process, including resolution or escalation • Apply therapeutic-area and product knowledge to scientific and business improvement projects • Work independently with R&D Quality Assurance to address inquiries and draft responses while maintaining an inspection-ready approach

🎯 Requirements

• 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, or healthcare authority • Bachelor's Degree or higher required; scientific discipline preferred • Outstanding written and oral communication skills • Comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas • Proficient in assimilating and analyzing complex data • Extensive experience writing and editing clinical and regulatory documents following ICH guidelines, GCP, and other regulatory requirements • Familiarity with CONSORT and PRISMA guidelines • Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology • Excellent writing skills • 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, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs