Who We Are

23andMe, the leading consumer genetics and research company, has accumulated a wealth of genotypic and phenotypic information from participants committed to improving human health through advances in genomics. Our Therapeutics team in South San Francisco leverages this data to discover and develop new treatments that can offer significant benefits for patients with serious, unmet medical needs.

This dedicated research and drug development group identifies novel targets using 23andMe’s genetic database and performs preclinical research to advance programs towards clinical development. We currently have programs across several therapeutic areas, including but not limited to oncology, respiratory, and cardiovascular diseases. More information about our Therapeutics team is available at https://therapeutics.23andme.com/.

23andMe Therapeutics is seeking an outstanding Regulatory and Scientific Communications Manager to join a collaborative, cross-functional development organization focused on bringing genetically-validated therapies to patients with high unmet needs. In this role, the candidate will independently oversee the development and authoring of a variety of deliverables across 23andMe Therapeutics. The successful candidate will take responsibility for delivering high quality content that is well aligned across the Therapeutics organization, with effective and eloquent messaging of information appropriately targeted to the relevant audience. 

We are seeking a candidate with a strong scientific background and experience with highly technical writing in an environment focused on therapeutic development, including regulatory submission deliverables and scientific publications. This exciting opportunity offers the potential to progress in leading the overall regulatory and scientific communication needs across 23andMe Therapeutics.

What You’ll Do

• 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. 

What You’ll Bring

• 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

Note: Job title will be commensurate with experience and academic credentials.

About Us

23andMe, headquartered in Sunnyvale, CA, is a leading consumer genetics and research company. Founded in 2006, the company’s mission is to help people access, understand, and benefit from the human genome. 23andMe has pioneered direct access to genetic information as the only company with multiple FDA authorizations for genetic health risk reports. The company has created the world’s largest crowdsourced platform for genetic research, with 80 percent of its customers electing to participate. The platform also powers the 23andMe Therapeutics group, currently pursuing drug discovery programs rooted in human genetics across a spectrum of disease areas, including oncology, respiratory, and cardiovascular diseases, in addition to other therapeutic areas. More information is available at www.23andMe.com.

At 23andMe, we value a diverse, inclusive workforce and we provide equal employment opportunity for all applicants and employees. All qualified applicants for employment will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.  If you are unable to submit your application because of incompatible assistive technology or a disability, please contact us at [email protected]. 23andMe will reasonably accommodate qualified individuals with disabilities to the extent required by applicable law.

Please note: 23andMe does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.