Principal Medical Writer

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $109.5k - $208.5k / year

⏰ Full Time

🔴 Lead

🏥📝 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

• Provide scientific publications or clinical regulatory document support and advanced scientific writing expertise to the clinical teams • Ensure successful preparation of high quality submission-ready documents and effective implementation of the writing process • Serve as medical writing lead on more complex scientific publications or clinical regulatory documents such as those associated with filings and dossiers • Implement all activities related to the preparation of scientific publications or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents • Serve as a department representative on project teams • Serve as a subject matter expert within department for assigned therapeutic/product areas • Act as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments • May mentor and provide guidance to more junior medical writers • Convert relevant data and information into a form that meets clinical regulatory document requirements • Confirm completeness of info to be presented • Work with Regulatory Quality Assurance throughout clinical regulatory document audit process • Recommend and implement tactical process improvements

🎯 Requirements

• Bachelor's degree in English or Communications with relevant science expertise or Bachelor's degree in Life Science with relevant writing expertise • Advanced degree and/or professional certification/credentials preferred • 3-4 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical • High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required • Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience • Working knowledge of statistical concepts and techniques • Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations • 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 • Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy • Experience in working with collaborative, cross-functional teams, including project management experience • Expert in word processing, flow diagrams, and spreadsheets • Excellent working knowledge of software programs in Windows environment.

🏖️ Benefits

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