Manager, Life Sciences - Regulatory Information Management
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POST DATE 9/12/2016
END DATE 10/18/2016
JOB DESCRIPTIONAPPLY The fastest growing Big Four professional services firm in the U.S., KPMG is known for being a great place to work and build a career. We provide audit, tax and advisory services for organizations in today's most important industries. Our growth is driven by delivering real results for our clients. It's also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it's no wonder we're consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you're as passionate about your future as we are, join our team.
KPMG is currently seeking a Manager in Technology Enablement for our Management Consulting practice.
- Ability to lead a global regulatory information management (RIM) deployment within the life sciences industry
- Educate clients regarding the process and data requirements needed to successfully deploy a RIM system
- Articulate the detailed steps involved in performing a technology enabled regulatory transformation as it relates to regulatory submissions and health authority commitments
- Identify the master data elements required, supporting process, and overarching governance principles required to maintain high regulatory data quality
- Ability to lead strategy and road mapping discussions related to where the industry maturity and vendor solutions are headed related to RIM best practices.
- Provide subject matter advisor support to clients related to ISO, IDMP, and XEVMPD standards
- Five years of project management within a life sciences regulatory or IT environment
- Three years of experience defining requirements, design, and implementations of RIM systems
- One year experience directly using Parexel, Aris Global, and/or Veeva platforms for regulatory processes
- Bachelor's degree in Business, Computer Information Systems or a related field from an accredited college/ university; Certifications with relevant associated years of experience applying PMP, ITIL, TOGAF, GxP a strong plus
- Prior experience working in Regulatory Affairs, Master Data Management, QA GxP environments, and/or IT strong plus
- Experience designing solution architectures to integrate various company systems for regulatory reporting a strong plus
- Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future
KPMG offers a comprehensive compensation and benefits package. KPMG, an equal opportunity employer/disability/veteran. KPMG maintains a drug-free workplace. KPMG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable local, state or federal law (including San Francisco Ordinance number 131192). No phone calls or agencies please. .