Manager, Medical Writing California-San Francisco
3/24/2015 3:48 PM

Responsible for supporting Clinical Development Lead in clinical protocol development, clinical study reports, Investigator's Brochures, IND/NDA. Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation and ensures documents are written in compliance with all regulations (ICH, GLP  ...View Job
Associate Director, Regulatory Affairs (Medical Device) California-San Francisco
2/25/2015 1:58 PM

Responsible for managing regulatory activities that support department and company projects and programs. Develops and ensures implementation of strategies and tactics for earliest possible approvals of drug and/or device filings and applications. Provides regulatory guidance and leadership to company and partner-sponsored project/program teams. Manages internal staff and external resources to ens  ...View Job
Associate Director, GCP Compliance California-San Francisco
2/25/2015 1:46 PM

This job contributes to and supports the company's research and development goal of creating high-value therapeutics by providing drug development programs with strategic GCP/GLP compliance support. This includes: A) Conducting internal and external quality assurance audits to assess compliance with GCP or GLP requirements and guidelines, and ensures implementation of CAPAs to address audit findi  ...View Job
Sr. Director, Regulatory Affairs California-San Francisco
2/25/2015 1:36 PM

Responsible for oversight of all regulatory activities of regulatory team. Develops strategies for earliest possible approvals of drug applications and device registrations. Ensures appropriate project/program Regulatory support. Participates in higher level interactions with external partners. Formulates corporate responses to regulatory agencies and pharmaceutical group initiatives. Functions as  ...View Job