Medical Writer II (CSR Narrative) – Gurugram, India (Hybrid) | 1–3 Years Experience Required
Location: Gurugram, India (Hybrid)
Job ID: 25105488
Experience Required: 1–3 years in Medical Writing (CSR Narrative)
Employment Type: Full-Time
A leading global biopharmaceutical solutions organization is hiring a Medical Writer II (CSR Narrative) to support clinical and regulatory documentation within a dynamic, cross-functional environment. This hybrid opportunity in Gurugram is ideal for medical writers with hands-on experience in Clinical Study Report (CSR) narrative authoring and regulatory-compliant documentation.
This position plays a critical role in developing high-quality clinical and regulatory deliverables aligned with ICH, FDA, and global regulatory standards.
Author and edit Clinical Study Report (CSR) narratives with minimal supervision.
Develop and support clinical and regulatory documents including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Patient Narratives
Investigator Brochures
Annual Reports
Review statistical analysis plans (SAPs) and table/figure/listing (TFL) specifications for accuracy, consistency, grammar, and formatting.
Collaborate with cross-functional teams including Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.
Serve as a peer reviewer on internal review teams and address feedback to ensure scientific accuracy, clarity, and compliance.
Ensure adherence to ICH-E3 guidelines, FDA regulations, company SOPs, and client templates.
Conduct online clinical literature searches when required.
Maintain awareness of project timelines and budget allocations; proactively communicate risks.
Mentor junior medical writers as needed.
Participate in continuous professional development to stay aligned with evolving regulatory guidance.
Complete administrative and project-related tasks within defined timelines.
Travel may be required (less than 25%).
1–3 years of experience in medical writing with proven CSR narrative authoring experience.
Postgraduate qualification preferred (Life Sciences, Pharmacy, Medicine, or related field).
Strong knowledge of FDA regulations, ICH guidelines (especially ICH-E3), and regulatory documentation standards.
Familiarity with AMA style guide.
Demonstrated understanding of the drug development process.
Ability to interpret and present complex clinical data clearly and accurately.
High level of independence with strong proofreading, presentation, and interpersonal skills.
Proficiency in Microsoft Word, Excel, PowerPoint, and internet-based research tools.
Strong organizational skills with the ability to manage multiple deliverables simultaneously.
This global biopharmaceutical services provider operates across 110+ countries with a workforce of approximately 29,000 professionals. Over the past five years, the organization has contributed to:
94% of Novel FDA-approved drugs
95% of EMA-authorized products
200+ clinical studies
73,000 research sites
675,000+ trial patients
The company emphasizes structured career development, leadership engagement, therapeutic training, and a performance-driven culture designed to accelerate therapy development worldwide.
The Medical Writer II serves as a key contributor to clinical study and regulatory project teams, ensuring timely and compliant development of CSR narratives and associated documentation. This role requires scientific precision, regulatory knowledge, and strong collaboration across multidisciplinary teams.
The employer is committed to fostering a diverse and inclusive workplace. Candidates with transferable skills and relevant experience are encouraged to apply. Reasonable accommodations are provided in accordance with applicable laws and regulations.
Explore verified global opportunities in medical writing, pharmacovigilance, clinical research, regulatory affairs, and pharmaceutical sciences at ThePharmaDaily.com – your trusted global pharma career platform.
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