Medical Writer Group Lead – Drug Safety Services – Mysore
Location: Mysore, Karnataka
Department: Drug Safety Services
Employment Type: Full-Time
Job Overview:
As a Medical Writer Group Lead, you will lead the development and delivery of high-quality clinical and regulatory documents across various therapeutic areas. This role requires close collaboration with sponsors and internal teams to support comprehensive clinical trial documentation and global regulatory submissions. You will ensure compliance with ICH-GCP and regulatory standards while overseeing the planning, writing, and review process of key medical documents.
Key Responsibilities:
Author, review, and finalize a range of clinical and regulatory documents per ICH-GCP guidelines, global regulatory requirements, and sponsor-specific templates.
Deliver critical documentation, including but not limited to:
Clinical Study Reports (CSRs)
Patient Safety Narratives
Investigator’s Brochures (IBs)
Clinical Study Protocols and Amendments
Protocol Synopses, Clinical Trial Summaries, and related regulatory submissions
Interpret and synthesize clinical data from tables, listings, and figures for inclusion in regulatory reports.
Coordinate with clinical, biostatistics, pharmacovigilance, and project management teams to meet timelines.
Manage communication and document feedback with sponsors efficiently and professionally.
Ensure version control, SOP compliance, and adherence to quality and deadline requirements.
Qualifications:
Bachelor’s, Master’s, or PhD in Life Sciences, Pharmacy, Medicine, or related discipline.
8–12 years of relevant medical writing experience in a CRO or clinical research setting.
In-depth understanding of ICH guidelines and international regulatory requirements.
Proficiency in MS Word, Excel, PowerPoint; experience with document management systems.
Strong written and verbal communication skills.
Ability to manage multiple writing projects with attention to detail and accuracy.
Preferred Skills:
Experience with eCTD submissions and working with regulatory agencies.
Therapeutic area familiarity in oncology, CNS, cardiovascular, or rare diseases.
Knowledge of tools like Adobe Acrobat Pro and referencing software.
Estimated Salary: ₹15 – ₹25 LPA (based on experience and role expectations)
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