Job Description
**Overview**
We are seeking an experienced **Senior Medical Writer** to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as **Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs)** are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.
The successful candidate will act as a **lead writer for key summary documents** , providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the **Director of Medical Writing (or above)**
**Key Responsibilities**
+ Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketin...
We are seeking an experienced **Senior Medical Writer** to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as **Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and marketing authorization applications (MAAs/NDAs/BLAs)** are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements.
The successful candidate will act as a **lead writer for key summary documents** , providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the **Director of Medical Writing (or above)**
**Key Responsibilities**
+ Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketin...