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 a Medical Writer I to support the preparation, review, and delivery of clinical and regulatory documents. The ideal candidate will have a strong scientific background, excellent writing skills, and an understanding of clinical research and drug development processes.
Key Responsibilities
Author, edit, and review clinical and regulatory documents, including: Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, Patient Narratives
Conduct literature searches and scientific reviews to support document development.
Analyze and interpret clinical study data to prepare high-quality scientific content.
Ensure compliance with ICH-GCP guidelines, SOPs, templates, and regulatory requirements.
Perform quality checks to ensure data accuracy, consistency, and document integrity.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs.
Support document review cycles, manage timelines, and address stakeholder feedback.
Skills
Strong clinical and scientific writing skills.
Good understanding of clinical research, drug development, and regulatory guidelines.
Experience with medical writing, clinical documentation, or medical communications.
Excellent written and verbal communication skills.
Strong attention to detail and organizational skills.
Proficiency in Microsoft Word, Excel, SharePoint, and document management systems.
Ability to manage multiple projects and work effectively in a collaborative environment.
Qualifications
Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline.
Experience within a CRO, pharmaceutical, biotechnology, healthcare, or medical communications organization preferred.
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