Regulatory and Scientific Communications Manager/Senior Manager
Posted on 2/10/2023
San Bruno, CA, USA
Experience Level
Desired Skills
  • Degree in a scientific discipline with advanced degree (MS, PhD) preferred
  • 5+ years of experience as a medical writer in biotech or pharmaceutical industry with excellent English language and technical terminology fluency
  • Significant experience authoring regulatory submission deliverables across nonclinical and clinical IND modules, including nonclinical summaries (M2), study reports (M4), investigator brochure (M1), and clinical protocols (M5). Experience in all CTD modules, including CMC sections (M3) as well, is highly desirable
  • Strong understanding of the regulatory environment for drug development in both US and ex-US
  • Strong attention to detail and excellent communication, prioritization, and organizational skills
  • Ability to work independently, solve complex problems, maintain tight timelines, and balance multiple deliverables simultaneously
  • Knowledge of electronic document and submissions standards, including eCTD structure preferred
  • Independently lead the development, authoring, revising, adjudicating, and formatting of a variety of documents including regulatory submission deliverables, study reports, clinical documents, and scientific publication content
  • Work cross functionally with subject matter experts for content development, document review, and adjudication processes, ensuring that documents are efficiently managed and delivered according to timeline
  • Proactively organize processes and meetings with team members to facilitate deliverable development from planning through finalization
  • Maintain high organization standards including thorough adjudication of comments and traceability to comment history and adjudication decisions throughout the review process
  • Serve as a key reviewer of deliverables authored by other team members, providing both editorial review and regulatory review for alignment with strategy and requirements
  • Oversee the execution of cross-functional contract deliverables that necessitate high quality output and technical writing expertise
  • Engage vendors or contractors for medical/scientific/regulatory writing services, overseeing deliverables and managing services and contracts

501-1,000 employees

Personal genomics & biotechnology company
Company Overview
23andMe’s mission is to help people access, understand, and benefit from the human genome. The company has created the world’s largest crowdsourced platform for genetic research and is the only company with multiple FDA authorizations for genetic health risk reports. The company is also in development of discovery programs rooted in a diverse spectrum of human genetics to ultimately deliver reports and results from all spectrums of your DNA.
  • Comprehensive health, vision, & dental plans
  • Family planning, support, & leave for parents
  • Mental healthcare
  • Student loan assistance
  • Volunteer time off
  • Dog friendly office
Company Core Values
  • Think big
  • We heart DNA
  • Lead with science
  • Get to yes or no, quickly.
  • Behind every data point is a human being
  • We're in this together