Medical Writer Group Lead
Location: Mysore, Karnataka
Department: Drug Safety Services
Employment Type: Full-Time | Experienced
Role Overview:
As the Medical Writer Group Lead, you will oversee the creation of essential clinical and regulatory documentation across various therapeutic areas. This role involves hands-on authorship of documents, collaboration with sponsors and internal stakeholders, and strategic oversight of timelines and quality standards. You will be instrumental in supporting regulatory submissions and guiding your team to ensure compliance, clarity, and scientific integrity.
Key Responsibilities:
Clinical & Regulatory Writing:
Draft, review, and finalize a wide array of clinical and regulatory documents aligned with ICH-GCP, global regulatory guidelines, and sponsor-specific templates:
Clinical Study Reports (CSRs)
Patient Safety Narratives
Investigator’s Brochures (IBs)
Clinical Study Protocols and Amendments
Protocol Synopses, Clinical Trial Summaries, and additional regulatory documents.
Data Interpretation & Collaboration:
Analyze and interpret clinical data from statistical tables, figures, and listings.
Work cross-functionally with clinical, biostatistics, pharmacovigilance, and project management teams to ensure accuracy, clarity, and timely delivery of documents.
Client & Team Management:
Liaise with sponsor teams, effectively managing feedback, revisions, and queries.
Maintain version control and compliance with SOPs, templates, and regulatory expectations.
Ensure adherence to document timelines and facilitate high-quality output through collaboration and guidance.
Required Qualifications:
Education: Bachelor’s, Master’s, or PhD in Life Sciences, Medicine, Pharmacy, or a related field.
Experience:
8–12 years of medical writing experience in a CRO, pharmaceutical company, or clinical research environment.
Proven knowledge of ICH guidelines, regulatory pathways, and submission standards.
Proficiency in MS Word, Excel, PowerPoint, and familiarity with document management systems.
Preferred Qualifications:
Exposure to eCTD submissions and regulatory agency communication.
Experience in therapeutic areas such as oncology, cardiovascular, CNS, or rare diseases.
Familiarity with tools like Adobe Acrobat Pro and reference management software (e.g., EndNote, Mendeley).
Estimated Salary: ₹14–22 LPA
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