Company: Key People Limited
Closing Date: 09 Dec 16
Salary (£): Negotiable
Regulatory Documentation ScientistLeading Pharmaceutical company6 month contractFreelance opportunityFull time office based Basel
This client is a leading Pharmaceutical company they are looking for a Regulatory Documentation Scientist to join their team, office based in Basel. Candidates will work on a freelance basis for 6 month contract.
Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guidelines/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 our client and 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
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