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Associate Regulatory Writer Graduate

Job details
Posting date: 16 June 2025
Hours: Full time
Closing date: 16 July 2025
Location: London, London, W12 7FQ
Remote working: Hybrid - work remotely up to 2 days per week
Company: SRG
Job type: Contract
Job reference: BBBH163588_1750084654

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Summary

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
  • 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/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.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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