Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.
In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.
- Full Time
- Level: Mid
- Travel: No
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Work-life Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Career Development
Opportunity to learn and grow through a performance and development goal-setting program.
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Home based
Love where you work, and work where you love.
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Variety
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Responsibilities
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
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