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The Director, Regulatory Writing plans, authors and manages regulatory/clinical documents to support clinical development programs and regulatory submissions. Assists with the management of external resources to prepare regulatory/clinical documents. This position will be located in Palo Alto, CA and reports to the Sr. Director, Global Regulatory Communication.

Key Responsibilities

• Plans, develops, and/or provides oversight of clinical/regulatory documents, such as CSRs of all phases, Investigator Brochures, CTD summaries, PIPs, briefing packages, responses to agency questions, and other document types as needed, according to ICH guidances, regulatory requirements and internal document standards.

• Represents Regulatory Writing on cross-functional project teams. Participates in regulatory teams, providing advice/guidance to the team on regulatory document requirements and optimal presentation of data.
• Assists with the management of document timelines/resource planning.
• Works collaboratively with functional contributors (Clinical Development, Pharmacovigilance, Biometrics, Regulatory Affairs, Regulatory Operations, others), ensuring all source information and data are appropriately reported in terms of accuracy, completeness, and scientific interpretation, and in accordance with project timelines.
• Assists with the coordination of the compilation of final documents and appendices provided by other functions.
• Contributes to development of document and process standards, template development, and other aspects of document management.
• Assists with the management of external vendors or consultants to ensure document compliance with guidelines, as well as quality and adherence to timelines.
• Contributes to other non-regulatory writing activities as needed.

Requirements

• BA/BS and 10+ years Regulatory Writing experience, or MA/PhD and 8+ years of experience.
• Extensive experience in clinical-regulatory documents authoring to prepare clinical/regulatory documents as described above.
• Management of external resources preferred.
• Excellent verbal and written communication skills with the ability to effectively communicate with a variety of teams and individuals.
• Occasional business travel may be necessary.
  • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.
  • Salary Range: $220K-240K/year

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance