Principal Strategic Medical Writer

🕒 August 27

🌽 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 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 required for AbbVie drug and device development • 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 project dates • Contribute to project management strategies and lead team members in driving 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 • Apply therapeutic area and product knowledge to scientific and business improvement projects • Work independently with R&D Quality Assurance on inquiries and draft responses while maintaining inspection readiness

🎯 Requirements

• Minimum of 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 • Proficiency in assimilating and analyzing complex data • Extensive experience writing and editing clinical and regulatory documents according to 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 communicate 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, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs