The Regulatory Writer and Editor position ensures high quality documentation and submission production from the Invitae Regulatory Department by reviewing content for consistency of style and substantive accuracy.
- Review and edit for style, references, nomenclature, and accuracy of content among documents intended for external submission or publication as generated by the Regulatory Affairs team.
- Manage a queue of work in an organized fashion, via collaboration with functional project management, to ensure prompt turnaround.
- Create style guides and training on the proper creation of regulatory documentation. Incorporate feedback from cross functional partners as well as the primary regulatory authors.
- Oversee a quality check process for regulatory submissions to ensure independent review and editing from the authors of those documents. Manage ad hoc resources to conduct the quality check on tight timelines where appropriate.
- Collaborate with technical and medical writing teams across the company to ensure consistency of messaging and style across external-facing documents and publications.
- Demonstrable experience, via job duties or writing samples, of familiarity with citation styles, scientific writing principles and tools.
- 2 or more years of experience in diagnostics or related academia producing, owning and editing high quality technical and scientific writing.
- Positive attitude and a desire to be a “go-to” expert on questions of documentation style and review.
- Strong working knowledge of legislative and regulatory frameworks.
- Collaborative approach to the creation of high quality documents when pulling content from a variety of sources.
- Bachelor’s degree in a discipline focused on technical and professional writing. Advanced degree preferred.