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Associate Regulatory Writer Graduate, London
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Client:
SRG
Location:
London, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
2047c691c821
Job Views:
4
Posted:
14.07.2025
Expiry Date:
28.08.2025
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Job Description:
Job Title: Associate Regulatory Writer Graduate
Location: White City, London
Contract: 12 Months / Hybrid 3 days onsite
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
* Main sub-team representative at the Clinical Trial Team (CTT).
* Participate in planning of data analyses and presentation used in
* 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
* Maintain audit, SOP and training
Experience and Qualifications
Education:
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.
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