Gilead Sciences
Location
Foster City, California
Salary
$117,895 - $152,570 / YEAR
Supports the lifecycle of regulatory documents from creation to completion, ensuring adherence to eCTD specifications and standards. Collaborates cross-functionally with Research, Regulatory Affairs, and Clinical Development to ensure timely availability of submissions.
Requires a combination of education and experience, ranging from a high school diploma with six years of experience to a Master's degree with two years. Proficiency in MS Office, Veeva, and Smartsheet, along with strong organizational and communication skills, is preferred.
Responsibilities: Has general understanding of regulatory documents, the electronic common technical document (eCTD) specifications. Experience with electronic document management systems, and capable of supporting the lifecycle of regulatory documents, from creation to review and completion. Embraces technology, and have advanced working knowledge of Microsoft Word Able to format documents in MS Word. Understands and adheres to standards and processes, willing and able to do minute and repetitive tasks on the computer. Collaborates cross-functionally (Research, Regulatory Affairs, Regulatory Operations, Medical Writing/Content Managers, Clinical Development) to support timely availability of regulatory documents. Is able to work in ambiguous situations, sometimes without known precedence, and able to think critically to implement effective solutions. Able to manage multiple tasks simultaneously with strong attention to detail and work with tight deadlines, but flexible enough to pivot when necessary. Participates in process improvements, new standards, updating systems, and other activities related to continuous improvement in support of submissions. Is able to work onsite at least 3 days a week. Basic Qualifications: High School and Six Years’ Experience OR Associate Degree and Five Years’ Experience OR Bachelor's Degree and Four Years’ Experience OR Masters' Degree and Two Years’ Experience
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