Hawkins Point Partners Research Business Systems Anlayst in Cambridge, Massachusetts
Hawkins Point Partners has an immediate need on its Waltham, Massachusetts team for a Senior Business Analyst with experience supporting drug research-R&D business functions. Experience supporting discovery sciences-CMC/Supply Chain, compliance, and Infrastructure systems. This person would build strong relationships with business stakeholders and provide leadership throughout the business analysis lifecycle. The idea candidate would have proven skills in business process review/design, vendor selection, and requirements documentation. Must have an ability to author and collaborate on deliverables according to SDPO SDLC and Computer System Validation procedures (e.g. requirements specifications, user acceptance test protocols). Ability to provide mentorship and leadership is a plus.
Eight years of information technology systems experience-supporting life sciences applications including 21 CFR validated systems.
Elicit user requirements, create business process documentation and support solution design. Ability to write test plans and test scripts to UAT.
CMC clinical supply chain experience along with an understanding of research and clinical development business processes and regulatory requirements (GxP predicate rules, 21 CFR Part 11).
Collaborate with R&D business functions (Discovery Sciences, CMC/Supply Chain), IT Compliance, IT Infrastructure, QA, and other partners to identify, design, and implement IT solutions to meet current and future business needs.
Experience with biomarker computer applications to measurable biological states is a plus. This person will support biomarker group (supporting drug research and discovery) to help understand how the therapy may help other conditions)
Demonstrated success with implementing SaaS (cloud) system is a plus
Bachelor of Science or advanced degree in a related discipline.
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