Medical Writing Group Lead

Medical Writer Group Lead

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.