Senior Medical Writer

When 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.

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.

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.

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)