Associate Regulatory Writer Graduate
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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