Associate Director, Document Processing/Formatting/Publishing - Regulatory Operations

Location: Foster City, California US

Notice

This position is no longer open.

Job Number: 1051

External Description: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

Job Description
Associate Director, Document Processing/Formatting/Publishing - Regulatory Operations

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

About the role:

This is an exciting opportunity to lead the Document processing function within Regulatory Operations at Gilead. They will be managing a team of 13+ experienced document processing professionals. We are looking for an experienced leader to join our team of collaborative, passionate and team-oriented professionals.

Job Responsibilities:

  • Responsible for overseeing the Document processing/formatting team of 13+ staff members including the management of managers and senior managers.
  • Responsible for maintaining and developing new document formatting standards, processes and ensuring document templates remain compliant with regulatory and company standards
  • Leads the document processing team in preparation of complex regulatory submissions.
  • Works with authors and functions throughout Gilead to ensure document formatting processes are efficient and compliant with changes in business or health authority requirements.
  • Full understanding of submission document formatting standards and PDF requirements for US and International regulatory standards
  • Must have in-depth knowledge of regulatory requirements, including ICH and regional requirements for submission documents.
  • Can manage document processing team with minimal supervision from senior management
  • Ensures up-to-date knowledge of regulatory submission requirements and communicates changes in regulatory information to project teams and senior management in a timely manner.
  • Management of staff from Associates to Senior Manager levels
  • Support the company mergers and acquisitions for Document Processing.
  • Communicates the status of ongoing projects to internal senior management and across functions as appropriate. Provides support for project roll-outs where necessary.
  • Initiates local process improvements and contributes to local and / or global process improvements, which have a significant impact for the Regulatory operations department or other departments.
  • Plans, schedules and arranges own activities and those of direct reports (if applicable).
  • Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail
  • Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines
  • Is able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers
  • Must be able to direct and oversee work projects effectively within an environment that has quickly changing processes, priorities and deadlines.
  • Must be able to streamline all processes from highly complex to routine to improve efficiency, productivity, and add value.
  • Acts as internal stakeholder for projects and sits on steering teams as applicable
  • Must be capable of leading a team in preparation of complex regulatory submissions by providing the document formatting support.
  • Previous people management experience is required.


Education & Experience:
  • 10+ years of relevant experience and a BA or BS
  • 8+ years of relevant experience and an MS.
  • 4+ years of management experience
  • Extensive experience in document processing, formatting or publishing is required.
  • An extensive familiarity with pharmaceutical development and global regulatory submissions is required.
  • Experience rolling out and maintaining document formatting standards and templates for use in regulatory submissions is highly desirable.


Technical/Software Skills:
  • MS Word, Adobe Acrobat, ISIToolbox, DocX tools, EndNote, Documentum/Other Document management system

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Number: R0011822

Community / Marketing Title: Associate Director, Document Processing/Formatting/Publishing - Regulatory Operations

Location_formattedLocationLong: Foster City, California US

 

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