HawkinsPointPartners Regulatory Business Systems Analyst in Cambridge, Massachusetts
Hawkins Point Partners has an immediate need for a Senior Business Analyst with expertise supporting 21 CFR Regulatory environments. The ideal candidate with have a drug manufacturing regulatory and compliance foundation-along with the ability to facilitate business requirements sessions. Strong Business Analyst skills are a must to support functional and technical requirements documentation and UAT. Process mapping and workflow diagram development for operational processes in support of CMC Change management, Regulatory Information Management (Publishing (eCTD processing). Business process analysis skills to assess technology systems. Ability to provide analysis of regulatory impact and need to be reported via the Quality organization. This effort will support a new manufacturing path (change) and drug product release to distribution schedule.
Strong customer service skills and experience supporting business and technical team members. Must be able to execute in a progressive and collaborative working environment.
Requirements gathering and user documentation for CMC and RIMS systems (knowledge of eCTD for US, EU and AsiaPac).
Ability to facilitate business requirements sessions. Core Business Analyst skills and experience supporting functional and technical requirements, provide documentation, UAT, process mapping diagrams, workflows, etc.
Process and operational knowledge of CMC Change management, CAPA, Publisher, eCTD and Regulatory Information Management Systems.
Regulatory knowledge and ability to analyze the business process and operational verse understanding regulations. Ability to adapt process while in compliance with 21 CFR. Must demonstrate strong process, facilitation, awareness of the regulatory process.
Bachelor of Science or advance degree in related discipline.
Certified Business Analyst Professional (CBAP) is a plus.