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SRG

Associate Regulatory Writer Graduate

City of London Full-Time 25000 - 36000 £ / year (est.) Home office (partial)

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

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.

Associate Regulatory Writer Graduate employer: SRG

Join a leading pharmaceutical company in White City, London, where you will be part of a dynamic team dedicated to producing high-quality clinical documentation. With a strong emphasis on employee growth and development, the company offers a supportive work culture that encourages collaboration and innovation. Enjoy the benefits of a hybrid working model, competitive salary, and the opportunity to contribute to meaningful projects that impact global health.