Senior Manager, QC Editing
Remote, CA 92121 US
Responsible for working collaboratively with clinical development functions as well as Technical Operations to develop clinical and regulatory documents from initial concept through final review and approval. In this role, the successful candidate works collaboratively with clinical functions in support of the development of regulatory documents through finalization. The medical editor substantively edits and performs QC and consistency checks on documents to ensure that they are of high quality and partners with Development Sciences, Translational Sciences, Medical Writing, Regulatory leads, and Regulatory Operations to finalize them.
- Leads/coordinates and determines resources for (both internal and external) editing and QC efforts for all developed regulatory documents.
- Edit and support QC on documents to ensure timelines are being met
- Supports Regulatory leads, medical writers, Development Sciences authors, and Translational Sciences authors to ensure efficient development of high-quality regulatory documents while meeting agreed-to document development timelines
- Establishes and maintains cross-functional relationships in support of program goals
- Leads non-program initiatives and activities.
- Supports development and maintenance of regulatory document templates and style guide(s)
- Maintains up-to-date knowledge of the regulations and guidelines related to regulatory document structure and content as well as GxP quality standards
- 7+ years of industry experience with a Pharmaceutical or Biotechnology company and a strong 4+ years of editing and or document QC experience
- Minimum of a Bachelor’s Degree at an accredited University
**CO/NY candidates may not be considered
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