Hobson Prior is recruiting for a Regulatory Documentation Scientist to join a multinational healthcare company located in Hertfordshire. This position will be responsible to prepare regulatory documents for submission to regulatory authorities within subject area.
- You will prepare regulatory documents in association with appropriate regulatory guidelines/company standards/SOPs.
- Plans and produces timelines for the production and review of documents ensuring alignment with overall project timelines.
- Communicates with document contributors to gather information (including Licensing partners where relevant).
- Reviews documents for organization/clarity/grammar/scientific standards/internal consistency.
- Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments.
- Assure 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 the company and regulatory guidelines, procedures and best practices across relevant documents.
- Contributes as a member of key functional/cross functional Teams to ensure that teams adequately plan for document deliverables.
- Actively contributes to best practices and continuous improvement within Regulatory Documentation.
- Keeps up-to-date on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas.
- Resolves issues, errors, or inconsistencies in data with contributors as appropriate.
- Capable to independently analyse and synthesize data from a broad range of disciplines.
- Project management skills with the ability to achieve multiple tasks and goals on-time.
- Good interpersonal and verbal communication skills.
- Ability to work effectively in a team environment and establishes strong collaborative relationships.
- Bachelor’s degree or equivalent.
- Clinical, medical and regulatory writing experience is a must.
- Advanced degree in life sciences or other relevant field is preferred.
- Demonstrated clear, high-quality scientific writing style in the English language
- Prior experience in regulatory affairs or related functions in drug development preferred
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.