Senior Strategic Medical Writer

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 • Prepare clinical and regulatory documents needed for AbbVie drug and device development • Draft materials with moderate autonomy and obtain review from subject matter experts and senior writers • Develop knowledge of submission strategies • Coordinate review, approval, and quality control across functions involved in clinical and regulatory projects • Arrange and conduct team review meetings • Produce and maintain high-quality, compliant clinical and regulatory documents within project timelines • Take greater responsibility for driving submission objectives and apply project management concepts • Develop knowledge of US and international regulations, requirements, and guidelines • Participate in tactical process improvements • Identify and propose solutions to issues arising during the writing process, resolving or escalating as appropriate • Work with leadership and R&D Quality Assurance to address inquiries and draft responses • Support an inspection-ready approach • Remain seated continuously for prolonged periods, more than 2 consecutive hours in an 8-hour day

🎯 Requirements

• 4+ years of bio-pharmaceutical industry experience in 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 • Experience writing and editing clinical and regulatory documents following ICH guidelines, GCP, and other regulatory requirements • Familiarity with CONSORT and PRISMA guidelines • 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 • EU and US device writing experience is a plus

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote work option • Equal opportunity employer • Reasonable accommodation for US & Puerto Rico applicants