Principal Medical Writer

🕒 4 days 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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Provide advanced medical writing expertise and scientific publication or clinical regulatory document support to clinical teams • Lead complex scientific publications and clinical regulatory documents associated with filings and dossiers • Prepare abstracts, posters, oral presentations, manuscripts, and comprehensive clinical regulatory submission packages • Serve as a department representative on project teams and subject matter expert for assigned therapeutic or product areas • Interface with PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, and Publishing groups • Convert, interpret, and explain scientific data for target audiences and regulatory or journal/congress requirements • Coordinate review, approval, production, and delivery of scientific publishing and clinical regulatory projects • Arrange and conduct team review meetings and ensure required documentation is completed • Advise teams on compliance with US and international regulations, journal/congress guidelines, ICH requirements, templates, and SOPs • Communicate deliverables, writing processes, and timelines; negotiate outcomes and resolve conflicts and document content issues • Work with Regulatory Quality Assurance during clinical regulatory document audits and draft responses as needed • Recommend and implement tactical process improvements • Mentor and guide junior medical writers as needed

🎯 Requirements

• Bachelor's degree in English or Communications with relevant science expertise, or bachelor's degree in Life Science with relevant writing expertise • 3–4 years of relevant industry experience in medical writing in healthcare or academia, or related quality, regulatory, clinical research, or product support/R&D experience • American Medical Writing Association (AMWA) certification or other certification preferred • High-level content writing experience with all types of clinical publications or clinical regulatory documents • Expert ability to assimilate and interpret scientific content and translate it for appropriate audiences • Working knowledge of statistical concepts and techniques • Expert knowledge of US and international regulations, requirements, and guidance for scientific publications or clinical regulatory document preparation and submissions • Knowledge and expertise with Common Technical Document content templates • Expert knowledge of current electronic document management systems and information technology • Excellent written and oral communication skills • Superior attention to detail and ability to correct spelling, punctuation, grammar, consistency, clarity, and accuracy errors • Experience working with collaborative, cross-functional teams, including project management experience • Expert proficiency in word processing, flow diagrams, and spreadsheets • Excellent working knowledge of software programs in a Windows environment

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical insurance • Dental insurance • Vision insurance • 401(k) • Eligibility to participate in long-term incentive programs