Principal Medical Writer

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Provide support for scientific publications or clinical regulatory documents and offer advanced scientific writing expertise to the clinical teams.

• Ensure the effective preparation of high-quality, submission-ready documents and the successful implementation of the writing process.

• Act as the medical writing lead for more intricate scientific publications or clinical regulatory documents related to filings and dossiers.

• Oversee all tasks associated with the preparation of scientific publications or the compilation of data and information into a cohesive package for new and updated clinical regulatory documents.

• Represent the department on project teams.

• Serve as a subject matter expert within the department for designated therapeutic or product areas.

• Function as a Subject Matter Expert for assigned clinical teams concerning computer-based technologies utilized by the respective departments.

• May provide mentorship and guidance to junior medical writers.

• Transform relevant data and information into formats that satisfy clinical regulatory document requirements.

• Verify the completeness of the information to be presented.

• Collaborate with Regulatory Quality Assurance during the clinical regulatory document audit process.

• Suggest and implement tactical process improvements.

⛳️ Requirements

• Bachelor's degree in English or Communications with relevant scientific expertise, or a Bachelor's degree in Life Science with pertinent writing expertise.

• An advanced degree and/or professional certification/credentials are preferred.

• 3-4 years of relevant industry experience in medical writing within the healthcare sector or academia is required, or in a related field such as quality, regulatory, clinical research, or product support/R&D.

• Certification from the American Medical Writing Association (AMWA) or equivalent is preferred, particularly with a specialty in Editing/Writing or Pharmaceutical.

• Extensive content writing experience and familiarity with all forms of clinical publications or clinical regulatory documents are required.

• Proficient in the assimilation and interpretation of scientific content, with a strong ability to translate it for the appropriate audience.

• Working knowledge of statistical concepts and techniques.

• In-depth understanding of US and international regulations, requirements, and guidance related to scientific publications or clinical regulatory document preparation and submissions, with the ability to advise teams on compliance.

• Knowledge and expertise in Common Technical Document content templates.

• Expert-level knowledge of current electronic document management systems and information technology.

• Outstanding written and oral communication skills.

• Exceptional attention to detail.

• Ability to identify and rectify errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.

• Experience collaborating within cross-functional teams, including project management experience.

• Proficient in word processing, flow diagrams, and spreadsheets.

• Excellent working knowledge of software programs in a Windows environment.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) for eligible employees.

• Long-term incentive programs.