Senior Medical Writer | Regulatory Writing & CTD | Pharma Jobs
Company: Not Disclosed
Location: India
Job Type: Full-Time
Work Mode: On-site / Hybrid (as per company policy)
Experience: 5+ Years
Category: Medical Writing / Clinical Research / Regulatory Affairs
Job Overview
We are seeking a Senior Medical Writer with strong expertise in regulatory medical writing, clinical documentation, and CTD submissions.
This role is central to the drug development lifecycle, involving preparation of clinical trial protocols, clinical study reports (CSR), regulatory dossiers (IND, NDA, BLA), and safety narratives.
You will collaborate with cross-functional teams including biostatistics, data management, regulatory affairs, and clinical operations, ensuring delivery of high-quality, compliant, and submission-ready documents aligned with ICH, GCP, and global regulatory standards.
Key Responsibilities
Regulatory & Clinical Writing
Prepare and review clinical trial protocols (Phase I–IV) and bioequivalence studies
Author Clinical Study Reports (CSR), feasibility synopses, and study outlines
Develop Common Technical Documents (CTD – Modules 2.4, 2.5, 2.6, 2.7)
Draft IND, NDA, BLA, MAA, 505(b)(2), biosimilar, and hybrid submissions
Clinical Documentation & Safety Writing
Prepare Informed Consent Documents (ICD), Investigator Brochures (IB), subject diaries
Write and review SAE narratives and safety documentation
Develop ISS (Integrated Summary of Safety) & ISE (Integrated Summary of Efficacy)
Regulatory Strategy Support
Draft Pre-IND, Pre-NDA, and regulatory briefing packages
Prepare orphan drug designation reports and expedited approval documentation
Support regulatory submissions to FDA, EMA, and global health authorities
Cross-Functional Collaboration
Work closely with biostatistics, data management, regulatory affairs, and clinical teams
Review study documents like SAPs, TLFs, eCRF outlines
Coordinate medical writing activities across multiple studies
Quality, Compliance & SOPs
Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs
Perform technical review and quality checks of all documents
Support development and maintenance of SOPs and documentation standards
Project & Stakeholder Management
Manage timelines and deliverables for multiple writing projects
Interact with clients, Key Opinion Leaders (KOLs), and internal stakeholders
Ensure high-quality deliverables aligned with client expectations and regulatory standards
Required Skills & Qualifications
Education
Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MSc / PhD / PharmD / MD)
Experience
Minimum 5+ years of experience in regulatory medical writing
Proven track record in clinical and regulatory document preparation
Technical Skills
Strong expertise in:
CTD Modules (2.4, 2.5, 2.6, 2.7)
IND, NDA, BLA, MAA submissions
ICH-GCP guidelines and global regulatory frameworks
Knowledge of clinical trial processes, statistics, and data interpretation
Proficiency in Microsoft Word, PowerPoint, Excel, Adobe Acrobat (PDF editing)
Core Competencies
Excellent scientific writing and communication skills
Strong attention to detail and quality focus
Ability to manage multiple projects and tight deadlines
Strong collaboration and stakeholder management skills
Problem-solving mindset with regulatory awareness
Preferred Skills
Experience in bioavailability/bioequivalence (BA/BE) studies
Familiarity with publication writing and congress submissions
Exposure to global regulatory submissions (FDA, EMA, PMDA)
Experience working with CROs, pharma companies, or consulting firms
Perks & Benefits
Opportunity to work on global regulatory submissions and drug approvals
Exposure to end-to-end clinical development and regulatory strategy
Career growth in medical writing, regulatory affairs, and clinical science
Collaborative environment with cross-functional teams
High-impact role in drug development and patient safety
Compensation
Salary Range: Not disclosed (competitive as per industry standards and experience)
About the Company
A fast-growing pharmaceutical / CRO organization focused on delivering high-quality clinical research, regulatory writing, and drug development solutions. The company supports global clients in achieving regulatory approvals, clinical excellence, and compliance with international healthcare standards.
Call to Action
If you want to work on high-impact regulatory submissions and shape how new drugs reach the market, this is your role.
Step into a career where your writing directly influences drug approvals, patient safety, and global healthcare outcomes.
👉 Apply now and become a key contributor in clinical and regulatory medical writing! 🚀
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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