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