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
* 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.
* May coordinate outsourced activities in RWS.
* Main sub-team representative at the Clinical Trial Team (CTT).
* Participate in planning of data analyses and presentation used in CSRs.
* May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
* May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
* May contribute to development of processes within RWS.
* Maintain audit, SOP and training compliance.
Experience and Qualifications
Education:
(minimum/desirable)
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Languages:
Fluent English (oral and written).
Experience / Professional Requirement:
* Some medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge.
* Understanding of global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
* Excellent communication skills(written, verbal, presentations)
* Understanding of biostatistics principles.
* Ability to prioritize and manage multiple demands and projects.
* Ability to define and solve complex problems (“Problem- solver”)
* Broad knowledge and future oriented perspective
* Understanding of matrix environment
* Global, cross-cultural perspective and customer orientation.