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VDart Inc
Alpharetta, GA
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Job Description :
Role: GXP Project Manager + BA Location: Cambridge, MA Duration: Contract JD: R&D IT Regulatory Release Lead - The R&D IT Regulatory Release Lead will oversee the operational support enhancement requests which improve the functionality available to users of various Regulatory applications The R&D IT Regulatory Release Lead will work with the Regulatory IT Support Lead and Principal Business Analyst to document and manage enhancement requests via the standard governance process to determine priority, approval and timing of implementation of the request(s The Regulatory Release Lead has responsibility for the health and success of these releases within a matrixed organization that has direct relationships with various groups in the business as well as IT. Role Monitor, manage, and ensure delivery of projects in a deadline-driven environment. Co-Lead requirements elicitation sessions Develop process knowledge to translate to business and technical requirements Author SDLC deliverables for review Assist in testing preparation and implementation of enhancements Support development of training materials, when applicable Contribute to the creation of operational support documentation Drive delivery and accountability of internal staff as well as vendors and third-party project managers Enable early identification and appropriate escalation of risks and issues that require assistance, attention, or management resolution Effectively communicate project status to Principal Business Analyst, verbally or in written form. The Regulatory Release Lead is accountable for ensuring that the enhancements are delivered according to committed scope, approved budget, and target dates. The Regulatory Release Lead will ensure that internal staff, as well as vendors and third-party project managers, provide committed project deliverables with a high level of quality. Experience: 5+ years' experience as a business analyst, with command of business analysis techniques & tools Comfortable with project methodologies, and familiarity with tools including MS Project and Excel Familiarity with use of and updating SharePoint sites Strong interpersonal and teamwork skills as well as solid analytical and creative problem-solving skills Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction. Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner. Capable of multi-tasking across projects; highly organized Familiarity with regulated systems (GxP, CFR 21 Part 11) and systems validation; Life Sciences, Biotech or pharmaceutical industry experience preferred. Education: BA or BS required Certification in Computer Science, Business, or Life Sciences-related field