Senior Medical Writer
Spyre Therapeutics
Principal Medical Writer
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Massachusetts, North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Write and edit clinical regulatory documents for clarity and accuracy according to client standards
- Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives
- Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs
- Ensure that documents comply with International Conference on Harmonization guidelines, SOPs, and Good Clinical Practices
Requirements
- At least 15 years of medical writing experience in the pharmaceutical industry
- Ability to write and edit complex material to ensure accuracy and clarity
- Experience with a variety of regulatory and clinical documents
- Experience in a matrix team environment
- Excellent written and oral communication skills and demonstrated problem-solving abilities
- Ability to handle multiple projects and short timelines
- Ability to work cooperatively with colleagues in a wide range of disciplines
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Benefits
- N/A 📊 Resume Score Upload your resume to see if it passes auto-rejection tools used by recruiters Check Resume Score
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory documentsclinical study protocolsinvestigator’s brochuresintegrated summariesliterature reviewsSOPsGood Clinical PracticesICH guidelinesCTD guidelines
Soft skills
written communicationoral communicationproblem-solvingproject managementcollaborationattention to detailtime managementadaptabilityteamworkclarity in writing
