Vaccines Research SRC Document Administrator

Job Category: Administrative/Clerical Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job SummaryThe incumbent will be supporting the SRC process and records management program for the Vaccines Research unit. Specifically responsible for formatting and assuring documentation associated with regulatory submission meets Wyeth Standards. The incumbent will also support scientists on use of SRC templates, will act as subject matter expert for SRC formatting and support documentation needs during regulatory filings.Job ResponsibilitiesFormatting of documents that may be included in a regulatory submission. Responsible for ensuring single native document formatting meets SRC Standards (e.g., ensuring fonts, tables, auto field’s bookmarks, and hyperlinks meet MS Word SRC Standards; redistilling of PDF’s received from third parties), and ensuring a single PDF renditions formatting and navigations meet SRC StandardsResponsible for internal quality review of an enhanced submission ready component and confirming the SRC is complete for issuance. This includes reviewing documents to ensure final quality of all SRC’s (format and navigation) of the native Word document.Serve as EDMS Document Coordinator for Vaccines Research Operations and back up for functional areas. Enter documents into document management system. Select appropriate object type, enter attributes, update formatting if necessary, generate PDF version with appropriate navigations, and issue document. Ensure documents are compliant with SRCs.Provide advanced word processing support for preparation and issuing of all Vaccine documents included in submissions. This requires a highly competent knowledge of word processing (e.g. MSWord) and publishing (Adobe Acrobat) applications, Submission Ready Component Standards, and Wyeth’s electronic document management systems (EDMS).Support scientists and administrative staff in use of submission -ready templates for reports and regulatory submissions, and EDMS. Act as subject matter expert and provide support to functional area personnel, as needed. Assist administrative staff in archiving documents in EDMS.Participate in records management inventory. In conjunction with supervisor and records management personnel, ensure conformance to record retention policies and support department in complying with corporate policies. Participate in records audits and PIP inspections.Satisfactorily completes all cGMP/GLP and safety training in conformance with Research requirements. Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements.Performs other duties as assigned.Basic QualificationsHigh School Diploma with 7+ years experience (AS +5).4 - 8 years experience working with documents, as a document specialist, administrative support, or other business/technical experience.Excellent computer skills and word processing skills are necessary. Prior experience working with SRC, document templates, working knowledge of MS Word, Adobe Acrobat, Visio, Excel are required. Contributor experience with EDMS and/or document management systems required. Ability to juggle multiple projects and to respond quickly to changing or urgent priorities. Strong communication skills and interpersonal skills required. Ability to work independently under minimal supervision.Relocation is not available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None Zip Code :US-NC-Sanford Leading the way to a healthier world.