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
About Parexel
Parexel is a leading global clinical research organization (CRO) committed to advancing clinical research and improving patient outcomes worldwide. We partner with biopharmaceutical companies, medical device manufacturers, and academic institutions to conduct high-quality clinical trials and deliver innovative solutions across all phases of development. Our multidisciplinary team of experts is dedicated to ensuring regulatory compliance, scientific excellence, and operational efficiency in every project we undertake.
About the Role
We are seeking an experienced Senior Medical Writer with specialized expertise in clinical trial disclosure and transparency to join our growing team. In this strategic role, you will lead the preparation, review, and delivery of clinical trial transparency submissions while providing regulatory guidance and mentoring junior team members. You will work with global clients to navigate complex disclosure requirements and ensure compliance with evolving regulations. This position offers the opportunity to make a meaningful impact on clinical research transparency and patient access to trial information.
Key Responsibilities
- Independently lead the preparation, review, and delivery of clinical trial transparency submissions, including protocol registrations, results postings, plain language summaries (PLS), lay protocol synopses (LPS), redaction/anonymization packages, anonymization reports, and CCI justification tables
- Advanced clinical and regulatory document authoring and review expertise, including Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports
- Provide strategic and regulatory guidance on clinical trial disclosure requirements to clients and internal teams
- Lead client interactions and provide disclosure-related consultation on complex regulatory matters
- Independently manage complex disclosure projects from initiation through delivery
- Provide regulatory interpretation and strategic recommendations to support client decision-making
- Contribute to process improvements and best practice development within the disclosure team
- Mentor and train junior team members on disclosure requirements, document development, and regulatory compliance
- Ensure all submissions meet quality standards and regulatory requirements across multiple jurisdictions
Required Qualifications
- Experience in medical writing field with demonstrated expertise in clinical trial disclosure and transparency
- Thorough understanding of global clinical trial disclosure and transparency regulations, including ClinicalTrials.gov, EudraCT, EU-CTR/CTIS, EMA Policy 0070, and Health Canada requirements
- Extensive experience with protocol registration, results reporting, registry maintenance, and disclosure compliance strategies
- Strong understanding of health literacy principles and demonstrated ability to develop clear, patient-facing disclosure documents
- Thorough knowledge of data protection regulations and their application to anonymization and redaction activities
- Advanced expertise in identifying and justifying PPD (Personally Identifiable Data) and CCI (Confidential Commercial Information) redactions
- Excellent written and verbal communication skills with ability to explain complex regulatory concepts clearly
- Bachelor's degree in life sciences, health sciences, or related field (or equivalent professional experience)
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