Documentation Specialist, Regulatory Publishing

Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Documentation Specialist, Regulatory Publishing. Assist in the preparation of regulatory documents for electronic submission to the FDA (eCTD). Responsibilities: * Prepare to publish, publish and QC FDA submission documents per eCTD Guidance and current departmental procedures using current departmental submission software. * Assist Regulatory Affairs professionals (RAPs) in the preparation of FDA submissions, i.e., procurement of information from different departments, create document template, word process additions/changes, and ensure formatting throughout application is consistent with department specifications. * Provide support to RAPs as assigned. * Supports necessary systems for manual and electronic information collection and retrieval related to tracking Regulatory Affairs activities (i.e., submission tracking, procurement of Petitions, FOI requests, competitive intelligence, etc.). * As instructed; procures, tracks and distributes FOI documentation for SBAs, 483s, EIRs, suitability or citizen's petitions, etc. When instructed, request regulatory certificates (e.g., Appostiles, Certificates to Foreign Governments, WHO certificates of Pharmaceutical Products, etc.). * Provide documentation electronically to other company entities and legal department as requested. Backup to Administrative Assistant, as needed. Supports Directors, answers phones, schedule appointments, etc. Primary Outcomes: * Electronic Submission to FDA formatted properly. * Deficiency templates setup in timely manner. * Ease in retrieving information for reporting purposes due to database maintenance. * Information easily found due to maintenance of submission. Qualifications: * Education Required: High school diploma or some college courses in Business, English, Computer discipline or equivalent work experience. * Experience Required: 2-3 years highly complex administrative experience: supporting high level executive. * Experience Preferred: 1 year in Regulatory Affairs. Understanding of regulatory guidelines and regulations with respect to filling of regulated documents. * Specialized or Technical Knowledge Licenses, Certifications needed: Extensive computer knowledge. High proficiency in Lotus Notes, MS Word, and Windows. Intermediate proficiency in Excel, Access and Power Point. As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business. Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com Click Employment Opportunities, then Positions Available and search for Position # 08-2826. No relocation is offered for the position. Only local candidates will be considered. Resumes will be reviewed and qualified candidates will be contacted for pre-screening. To Apply for this position, please CLICK HERE