Researcher / analyst
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 guidelines/Roche standards/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 Roche 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
Advanced degree in life sciences or other relevant field preferred.
Experience, Knowledge, Skills
- 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
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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