Medical Writer Group Lead
Location: Mysore, Karnataka
Department: Drug Safety Services
Employment Type: Full-time | Experienced
Company Overview
Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. We combine deep therapeutic expertise with innovative, technology-enabled solutions to help our clients focus on their core strengths. From early-phase studies to Phase III clinical trials, we provide high-touch services that emphasize safety, ethics, compliance, and innovation—delivering value to sponsors, patients, and the broader clinical research community.
Role Summary
The Medical Writer Group Lead will lead the development and delivery of high-quality clinical and regulatory documents across multiple therapeutic areas. This role requires strong cross-functional collaboration, client engagement, and oversight of end-to-end documentation processes supporting regulatory submissions and clinical trial reporting.
Key Responsibilities
Clinical & Regulatory Writing
Author, review, and finalize a range of documents in compliance with ICH-GCP, global regulatory guidelines, and sponsor-specific templates.
Deliver accurate and scientifically robust documents including:
Clinical Study Reports (CSRs)
Patient Safety Narratives
Investigator’s Brochures (IBs)
Clinical Study Protocols and Amendments
Protocol Synopses, Clinical Trial Summaries, and other submission documents.
Interpret and present clinical data from statistical outputs (tables, listings, figures).
Collaboration & Client Communication
Partner with cross-functional teams (clinical, biostatistics, pharmacovigilance, project management) to meet timelines and quality standards.
Serve as the primary contact for sponsor teams regarding medical writing deliverables.
Manage feedback and revisions to ensure client satisfaction.
Project & Quality Management
Maintain version control, compliance with SOPs, and adherence to submission timelines.
Ensure consistency, accuracy, and clarity across all documents produced by the team.
Qualifications
Bachelor’s, Master’s, or PhD in Life Sciences, Pharmacy, Medicine, or a related discipline.
8–12 years of medical writing experience in a CRO or equivalent clinical research setting.
Strong understanding of ICH guidelines and global regulatory requirements.
Proficiency in MS Office and familiarity with document management systems.
Exceptional written and verbal communication skills.
Strong analytical, organizational, and multitasking abilities.
Preferred Qualifications
Experience with eCTD submissions and regulatory agency interactions.
Knowledge in therapeutic areas such as oncology, CNS, cardiovascular, rare diseases.
Familiarity with Adobe Acrobat Pro and referencing software.
Estimated Salary Range: ₹20 – ₹30 LPA (based on experience)
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