Medical Writer II (CSR Narrative) – Remote India
Location: India (Remote)
Experience Required: 1–3 Years in Medical Writing (CSR Narrative)
Employment Type: Full-Time
Industry: Clinical Research | Biopharmaceutical | Regulatory Writing
Job Overview
A leading global biopharmaceutical solutions organization is seeking a Medical Writer II (CSR Narrative) to support clinical development and regulatory documentation projects. This remote India-based opportunity is ideal for professionals with hands-on experience in Clinical Study Report (CSR) narrative writing and regulatory-compliant medical documentation.
The role involves preparing high-quality clinical and regulatory documents aligned with FDA and ICH guidelines while collaborating with cross-functional clinical teams.
Key Responsibilities
Author and edit Clinical Study Report (CSR) narratives.
Develop and support preparation of:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Patient Narratives
Investigator Brochures
Annual Reports
Review Statistical Analysis Plans (SAPs), Tables, Figures, and Listings (TFLs).
Ensure compliance with ICH-E3 guidelines, FDA regulations, and company/client SOPs.
Perform clinical literature searches when required.
Collaborate with Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs teams.
Serve as peer reviewer to ensure scientific accuracy and clarity.
Mentor junior medical writers when necessary.
Manage deliverables within timelines and allocated budgets.
Stay updated with regulatory guidance and evolving medical writing standards.
Required Experience and Qualifications
1–3 years of experience in Medical Writing with CSR narrative authoring experience.
Strong understanding of drug development process and global regulatory requirements.
Knowledge of FDA regulations, ICH guidelines, and AMA style guide.
Postgraduate qualification preferred (Life Sciences, Pharmacy, Medicine, or related field).
Excellent written English and proofreading skills.
Ability to interpret and present complex clinical data clearly.
Proficiency in Microsoft Word, Excel, PowerPoint, and online research tools.
Strong communication and teamwork skills.
Minimal travel may be required (less than 25%).
Organization Overview
The organization operates in over 110 countries with 29,000+ professionals globally. Over the past five years, it has contributed to the development of 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products, supporting more than 200 clinical studies across 73,000 sites and 675,000+ trial patients worldwide.
The company follows a patient-centric clinical development model and promotes diversity, inclusion, and continuous professional growth.
Job Summary
The Medical Writer II serves as a key medical writing contributor on clinical study and regulatory project teams. The role focuses on drafting, editing, and coordinating regulatory documents to ensure scientific accuracy, compliance, and timely submission.
Uttar Pradesh :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
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Athens | Koropi |Greece :
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Manila |Croatia :
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Japan | Saitama |Tokyo :
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