About The Opportunity We're supporting a global clinical research organisation that is continuing to invest in its Medical Writing capability following continued growth across its Functional Service Provider (FSP) business.
This is an chance for an experienced Principal Medical Writer to join an established global team supporting international pharmaceutical and biotechnology clients. You'll take ownership of complex regulatory writing projects, work directly with global sponsors and play a key role in delivering high-quality submission documents across multiple therapeutic areas.
This role offers a high level of autonomy and would suit someone who enjoys leading projects, working directly with clients and mentoring junior team members, while remaining hands-on with medical writing.
Key Responsibilities
- Lead the preparation of complex clinical and regulatory documents for global development programmes.
- Prepare Clinical Module 2 submission documents, including:
- Clinical Overview
- Summary of Biopharmaceutics
- Summary of Clinical Pharmacology
- Summary of Clinical Efficacy
- Summary of Clinical Safety
- Briefing Documents
- Responses to Health Authority Questions
- Develop and review Clinical Study Protocols, Clinical Study Reports (CSRs) and other regulatory documents.
- Work closely with Clinical Operations, Biostatistics, Regulatory Affairs and Medical teams throughout the document development process.
- Provide scientific review of clinical documentation to ensure quality, consistency and regulatory compliance.
- Manage multiple writing projects simultaneously while meeting timelines and quality expectations.
- Mentor and support less experienced Medical Writers.
- Contribute to process improvements and medical writing best practices.
- Support proposal development and client-facing activities where required.
What We're Looking For
- Degree in Life Sciences or a related scientific discipline (Master's or PhD advantageous).
- Approximately 6+ years' Medical Writing experience within a CRO, pharmaceutical or biotechnology environment.
- Strong experience preparing Clinical Module 2 submission documents.
- Excellent knowledge of ICH guidelines and global regulatory requirements.
- Experience leading complex writing projects and working independently.
- Strong communication and stakeholder management skills.
Why Consider This Opportunity?
- Join a growing global Medical Writing team supporting international development programmes.
- Work directly with leading pharmaceutical and biotechnology sponsors.
- Take ownership of submission-level regulatory documentation with real impact on global drug development.
- Opportunity to mentor colleagues while remaining technically hands-on.
- Exposure to a broad range of therapeutic areas and global regulatory submissions.
- Flexible working environment with long-term contract potential.
📌 Principal Medical Writer (Kolkata Metropolitan Area)
🏢 Planet Pharma
📍 Kolkata Metropolitan Area
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