Senior Medical Writer – Regulatory Writing

Parexel

Senior Medical Writer at Parexel developing medical writing deliverables for regulatory writing portfolio. Preparing reports and coordinating with Study Management Team for clinical studies and safety assessments.

Posted 7/9/2026full-timeRemote • California • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio
Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs)
Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs)
Conducting critical appraisal and systematic review of literature with a focus on background epidemiology
Performing aggregate report compliance activities including quality review
Coordinates and liaises with the members of Study Management Team (SMT)
Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client
Responsible for the end-to-end signal management process

Requirements

What you’ll need

5+ years of direct experience in Regulatory Writing in a CRO or Pharma company setting
Good knowledge of medical terminologies
Science/Medicine degree: A minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Professional development opportunities

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Medical WritingRMP PreparationPeriodic Safety Update ReportsLiterature ReviewQuality Review

Soft Skills

CoordinationCommunication