Specialist II - Document Control
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POST DATE 8/27/2016
END DATE 10/13/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the PDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
* Lead creation of training materials in support of document processing and use of the EDMS
* Lead cross training of Document Coordinators throughout FC PDM
* Support UAT and Report Implementation in the EDMS Tool
* Create and maintain PDM QA Document Control SharePoint site
* Provide customer support for GDocs and processing of document changes
* Develop solutions to moderately complex problems
* Participate in determining objectives of assignments. Under guidance, plans schedules and arranges own activities in accomplishing objectives
* Represent organization as a contact on projects. Interact with internal and external personnel on moderate matters often requiring coordination between organizations
ESSENTIAL DUTIES AND JOB FUNCTIONS
Analyzes Change Requests (CRs) for completeness.
Communicates with customers to ensure changes are concise and complete.
Assists with the correct and timely implementation of CRs, Document Change Orders (DCOs) and Documents.
Maintains documentation manuals to ensure accuracy and current information.
Interacts with appropriate departments to establish priorities and deadlines for processing CRs, DCOs and documents.
Ensures the correct and timely input of database entries.
Revises standard operating procedures (SOPs) and work instructions for continuous improvement of documentation systems.
Coordinates the distribution and maintenance for GXP documentation.
Provides support to internal and regulatory audits/inspections as required.
Performs administration of the Quality Management System in support of GXP documentation.
May lead periodic review processes, supports the generation of monthly document control metrics.
Participates in the development of training materials.
Identifies areas for improvements, and proposes changes to management.
Performs advanced word processing tasks including providing support to customers with documentation issues.
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates general understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
Demonstrates good working knowledge of Document Control fundamentals, knowledge of the process, effects, and the relationship between the document change process and products.
Demonstrates general working knowledge of Quality Systems fundamentals.
Demonstrates general working knowledge of Electronic Document Management Systems (EDMS).
Demonstrates good understanding of system administration.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates proficiency in Microsoft Office applications.
6+ years of relevant administrative experience and a High School diploma.
4+ years of relevant experience in the pharmaceutical industry and a BS.
2+ years of relevant experience and a MS.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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