Job Description

About the Role:

As a

Medical Writer Group Lead

, you will play a pivotal role in the development of high-quality clinical and regulatory documents across multiple therapeutic areas. Working in close collaboration with sponsors and internal cross-functional teams, you will be responsible for authoring and delivering key documents such as

Clinical Study Reports (CSRs), Patient Narratives, Investigator's Brochures (IBs), Protocols

, and more--supporting end-to-end clinical trial documentation and regulatory submissions.

Key Responsibilities:

Prepare, write, and review a range of clinical and regulatory documents in compliance with ICH-GCP, sponsor-specific templates, and global regulatory requirements. Deliver high-quality, accurate, and scientifically sound 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 regulatory submissions Interpret and present clinical data from statistical tables, listings, and figures. Liaise with cross-functional teams including clinical, biostatistics, pharmacovigilance, and project management to ensure timely document delivery. Communicate effectively with sponsor teams and manage feedback and revisions collaboratively. Maintain version control and ensure adherence to timelines, SOPs, and quality standards.

Qualifications:

Bachelor's, Master's, or PhD in Life Sciences, Pharmacy, Medicine, or a related discipline. Minimum 8 - 12 years of medical writing experience in a CRO or similar clinical research environment. Demonstrated experience with ICH guidelines and global regulatory requirements. Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with document management systems. Excellent written and verbal communication skills. Strong analytical and organizational skills, with the ability to manage multiple projects simultaneously.

Preferred:

Experience with eCTD submissions and regulatory agency interactions. Familiarity with therapeutic areas such as oncology, CNS, cardiovascular, or rare diseases. * Knowledge of tools like Adobe Acrobat Pro, and referencing software.