Parexel is hiring for the position of Senior Medical Writer for its India-Bengaluru-Remote location. The role focuses on clinical trial disclosure and transparency, including regulatory submissions, clinical and regulatory document authoring, disclosure compliance, anonymization, redaction, and client consultation.
Job Details
| Job Detail | Information |
|---|---|
| Company | Parexel |
| Position | Senior Medical Writer |
| Job Location | India-Bengaluru-Remote |
| Job Type | Full Time |
| Job Requisition ID | R0000046124 |
| Work Area | Clinical Trial Disclosure & Transparency |
| Posted | Today |
Position
Senior Medical Writer
The Senior Medical Writer will lead clinical trial transparency submissions and provide regulatory guidance on disclosure requirements. The role also involves managing complex disclosure projects, working with global clients, and mentoring junior team members.
Responsibilities
- Lead the preparation, review, and delivery of clinical trial transparency submissions.
- Prepare protocol registrations, results postings, plain language summaries (PLS), and lay protocol synopses (LPS).
- Prepare redaction/anonymization packages, anonymization reports, and CCI justification tables.
- Author and review clinical and regulatory documents, including:
- Study Protocols
- Clinical Study Reports (CSRs)
- Investigator Brochures (IBs)
- Informed Consent Forms (ICFs)
- Clinical Overviews
- Clinical Summaries
- Safety Reports
- Provide strategic and regulatory guidance on clinical trial disclosure requirements.
- Lead client interactions and provide consultation on complex disclosure-related regulatory matters.
- Manage complex disclosure projects from initiation through delivery.
- Provide regulatory interpretation and strategic recommendations for client decision-making.
- Contribute to process improvements and best practices within the disclosure team.
- Mentor and train junior team members.
- Ensure submissions meet quality and regulatory requirements across multiple jurisdictions.
Eligibility / Qualifications
Candidates should have:
- Experience in the 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
- Health Canada requirements
- Extensive experience with protocol registration, results reporting, registry maintenance, and disclosure compliance strategies.
- Strong understanding of health literacy principles.
- Experience developing clear, patient-facing disclosure documents.
- Thorough knowledge of data protection regulations and their application to anonymization and redaction.
- Advanced expertise in identifying and justifying Personally Identifiable Data (PPD) and Confidential Commercial Information (CCI) redactions.
- Excellent written and verbal communication skills.
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field, or equivalent professional experience.
Required Skills
Key skills required for the Senior Medical Writer role include:
- Medical writing
- Clinical trial disclosure and transparency
- Regulatory document authoring and review
- ClinicalTrials.gov
- EudraCT
- EU-CTR/CTIS
- EMA Policy 0070
- Health Canada disclosure requirements
- Protocol registration
- Results reporting
- Registry maintenance
- Disclosure compliance
- Health literacy
- Patient-facing document development
- Anonymization and redaction
- PPD identification and justification
- CCI identification and justification
- Regulatory interpretation
- Client communication
- Project management
- Mentoring and training
Application Details
Interested candidates can apply for the Senior Medical Writer position at Parexel through the official job application page.
Job Location: India-Bengaluru-Remote