Principal Medical Writer- FSP
Primary Location: United States, Remote Job ID R0000035809 Category Medical Writing Date Posted 09/30/2025Overview
As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
About This Role
Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.
Job Purpose:
The Medical Writer, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality.
This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company’s objectives.
Key Accountabilities:
Oversight of activities
• Write and edit clinical regulatory documents for clarity, and accuracy
according to Sponsor 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, Sponsor Pharmaceuticals SOPs, and Good Clinical Practices.
Collaborative relationships
• Collaborates effectively with lead writers and project teams to develop
and refine clinical regulatory documents that align with Sponsor standards, ICH guidelines, and Good Clinical Practices, ensuring clear and accurate communication of study data and objectives within submission timelines.
Compliance with Parexel standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes,
ICH-GCPs and other applicable requirements
Skills:
• At least 4 years of writing experience in the pharmaceutical industry
• Experience with a variety of regulatory and clinical documents
• Experience in a matrix team environment
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Knowledge and Experience:
• Ability to write and edit complex material to ensure accuracy and clarity,
• 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
Education:
• BA/BS or higher
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Potential Career Path
Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
