Job Description
Job Title: Associate Regulatory Writer Graduate
Location: White City, London
Contract: 12 Months / Hybrid 3 days onsite
Hours: 37.5 per week
Rates: £31,050 p/a
Job Description
SRG are looking for an associate regulatory writer to join a leading pharmaceutical company based in London. The main purpose of this role is to write and/or edit under guidance high quality clinical and safety documentation.
Duties and Responsibilities
1. To write and/or edit under guidance high quality clinical and safety documents: Clinical Study Protocols (CSP) and protocol amendments, non-registration Clinical Study Reports (CSR),Development Safety Update Reports (DSUR), Clinical Trial Registration Documents.
2. May coordinate outsourced activities in RWS.
3. Main sub-team representative at the Clinical Trial Team (CTT).
4. Participate in planning of data analyses and presentation used in CSRs.
5. May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
6. May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
7. May contribute to development of processes with...