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
Job Summary
We are looking for an experienced Senior Medical Writer to author, review, and manage clinical and regulatory documents supporting global drug development programs. The ideal candidate will have expertise in clinical research documentation, regulatory writing, project leadership, and stakeholder management, ensuring the delivery of high-quality documents that meet regulatory and client requirements.
Key Responsibilities
Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
Conduct literature reviews and analyze scientific and clinical data to support document development.
Ensure documents comply with ICH-GCP, FDA, EMA, client requirements, SOPs, and regulatory guidelines.
Coordinate cross-functional reviews, manage document timelines, and incorporate stakeholder feedback.
Serve as the Medical Writing representative on project teams and act as a primary point of contact for assigned projects.
Review statistical outputs and ensure accurate presentation and interpretation of clinical data.
Perform quality reviews to ensure data consistency, accuracy, and publishing readiness.
Mentor junior writers and contribute to process improvement, training, and SOP development initiatives.
Required Qualifications
Bachelor's, Master's, PharmD, MD, PhD, or equivalent degree in Life Sciences, Pharmacy, Medicine, or a related field.
Must have experience in Medical Writing, preferably within a CRO, pharmaceutical, or biotechnology environment.
Strong experience authoring clinical and regulatory documents such as Protocols, CSRs, Investigator Brochures, and CTD documents.
Solid understanding of clinical research, drug development processes, and ICH-GCP guidelines.
Excellent scientific writing, editing, and communication skills.
Proficiency in Microsoft Word, Excel, document management systems, and collaborative authoring tools.
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