Senior Medical Writer
parexelDenver (CO)
About the role
Senior Medical WriterWhen our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 Clinical
- Trials.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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