Medical Writer Group Lead

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.