Senior Medical Writer

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead the preparation, review, and delivery of clinical trial transparency submissions, including protocol registrations, results postings, plain language summaries, lay protocol synopses, redaction/anonymization packages, anonymization reports, and CCI justification tables • Author and review clinical and regulatory documents, including Study Protocols, Clinical Study Reports, Investigator Brochures, Informed Consent Forms, 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 • 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 submissions meet quality standards and regulatory requirements across multiple jurisdictions

🎯 Requirements

• 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)