Immediate Need for Sr. Business Analyst – Regulatory - Franklin Lakes, NJ

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Title: Sr. Business Analyst – Regulatory
Location: Franklin Lakes, NJ


Detail:
Duration: 8 Months (FT resumes are welcome)Job Description: The Business Analyst will engage and partner with cross functional business teams to gather business requirements, perform gap analysis, develop functional requirements, define solution recommendations, draft business cases, perform vendor research, partner with internal and external development and testing teams to execute the projects, and perform other related duties. The Business Analyst should be familiar with R&D operations, GxP, SDLC, Agile, and related processes. The candidate should have knowledge of Regulatory Affairs and Document Management Systems (DMS)Core Responsibilities: 8+ years of business analyst experience in drug/medical device development R&D operationsUnderstand and document business processes/ problems and create solutions to meet desired business outcomes. Lead requirements gathering efforts including interviews and workshops.Strong understanding of end-to-end life sciences business processes, functions and technologies with an ability to fill the gap between business users and technologists.Create Business Process maps, SOPs, As-Is and To-Be Processes and data flow to enable implementation of Document Management SystemAuthoring various technical and business documentations e.g., business requirement, gap analysis etc.Knowledge of documents generated during Drug/Medical Device developmentGood knowledge of DMS systems knowledge (Veeva, Generis etc.)Provide Inputs for training, change management, document migration and system implementation.Must be able to take a problem statement and do industry research, come up with options/solutions available, putting a comprehensive business case, and roadmap.Work in a team of process consultants to plan and execute organizational strategy and digital transformation.Conduct rigorous quantitative analyses to generate insights about client business and IT processes, improvement, and value creation opportunities.Strong presentation, technical writing skills, analytical skills and hands-on GxP validation and compliance experience Strong networking skills, being proactive, motivational with the ability to work independently as well as have ability/willingness to work in a global environment.Prior experience in Decommissioning solutions and IT Transformation
 

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Thanks and Regards,

Y. PREMKUMAR

Aqua Information Systems Inc.



300 N Pottstown Pike, Suite # 130


Exton, PA 19341


Direct: 215-666-6795


Fax: 215-600-1617



Email:

pyellapu@aquainsys.com





URL:

www.aquainsys.com








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