Senior Medical Writer
Primary Location: India, Remote Job ID R0000046124 Category Medical Writing Date Posted 10/06/2026
Overview
As a Medical Writer at Parexel, your strong scientific knowledge, writing skills, and patient focus effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You must be able to collaborate within cross-functional teams to achieve the development of a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Adaptable
- Communicator
- Consistent
- Deadline-oriented
- Detail-oriented
- Insightful
About This Role
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)
#LI-REMOTE
Potential Career Path
Parexel offers career paths for Medical Writers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Associate Medical Writer
- Medical Writer I
- Medical Writer II
- Senior Medical Writer
- Subject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
WHY MEDICAL WRITERS WORK AT PAREXEL
