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Reed
,
Welwyn Garden City, Hertfordshire
Regulatory Documentation Scientist
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Salary: £34.6 per hour |
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Overview
Regulatory Documentation Scientist Our prestigious client based in Welwyn Garden City are looking for a Regulatory Documentation Scientist to work in their ever growing successful global team. The company are a Global organisation specialising within Medical science. They have been established for many years, providing a worldwide presence within the Pharmaceutical industry. Position Purpose: To prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety). The Regulatory Documentation Scientist takes accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. The Regulatory Documentation Scientist applies scientific writing, editing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management. Major Responsibilities and Accountabilities: Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guideline/SOPs, ensuring high scientific quality and consistency with other documents where appropriate Liaises with document contributors to gather information (including Licensing partners where relevant) Plans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate. Resolves issues, errors, or inconsistencies in data with contributors as appropriate Reviews documents for: organization/clarity/grammar/scientific standards/internal consistency (e.g., between text and data displays). Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments Ensures that documents are published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory Obtains and applies knowledge of regulatory guidelines, procedures and best practices across relevant documents Participates as a member of key functional/cross functional Team (s) (e.g. Regulatory Affairs Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables Actively contributes to best practices and continuous improvement within Regulatory Documentation Keeps informed on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas Qualifications Bachelor’s degree or equivalent. Advanced degree in life sciences or other relevant field preferred. Experience, Knowledge, Skills Demonstrated clear, high-quality scientific writing style in the English language Experience in regulatory affairs or related functions in drug development preferred Ability to independently analyze and synthesize data from a broad range of disciplines Project management skills: consistently achieves multiple tasks and goals on-time Good interpersonal and verbal communication skills Ability to work effectively in a team environment, establishes strong collaborative relationships Other: Occasional overseas travel may be required. For more information and to register your interest for this role please apply and the team will be back in touch with you. If you are unsuitable for this vacancy then REED has many other opportunities we could discuss with you. Good Luck with your application