Business Systems Analyst - validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy *** Direct end client *** Hybrid model

Business process, Business analysis, Cross-functional, Data management, Workflow, Project management, Process flow, Process modeling, Implementation, GxP, Mapping, Documentation, Use cases, Specification, Software development methodology, Analytical skill, business analyst, analytics business systems analyst, Acceptance testing, Accountability, Agile, Attention to detail, Clarity, Communication skills, Computerized system validation, Evaluation, Instructional design, Microsoft Office, Organizational change management, Organized, Planning, Presentations, SOP, Software deployment, Technical writing, Waterfall, Data storage, Onboarding, Process improvement, senior business analyst, data analyst, Analytics business analyst, GDPR, Good Clinical Practice, Systems Analyst, 21 CFR, 21 CFR part 11, Business Systems, Excellent written, Data Privacy, application development, budget, change management, budgets, business processes, business requirements, problem solving, business solutions, decision - making, scheduling, user acceptance testing, verbal communication, financial controls, pharmaceutical industry, re - engineering, relationship building, well - organized
Contract W2, Contract Independent, Contract Corp-To-Corp, 12 Months
Depends on Experience
Work from home available Travel not required

Job Description

Your specific responsibilities will include:

  • Concurrently manage multiple projects of diverse scope across functional areas

  • Manage and deliver projects using agile and waterfall methodologies

  • Manage project budgets, scheduling, planning and contractor resource assignment and track vendor and consultant performance including billing against budget and contract

  • Collaborate with Product Managers, Architects, Engineers, Developers, and User Experience Designers on scope, solutions, constraints, and risks.

  • Manage compliance documentation processes and systems for department and business partners

  • Characterize for compliance purposes as-built and vendor provided business solutions that may involve automated systems and/or modifications to business processes.

  • Provide expertise in documenting the deployment of systems and/or processes.

  • Perform a key role – as part of a project team in delivery of solutions that are cost effective, sustainable, and meet business requirements.

  • Be accountable for documentation, which may include, but is not limited to:

  • System Risk Assessments

  • Data Classification Reports

  • User Requirements

  • Validation Plans

  • Validation Reports

  • Validation Registries

  • Requirements Traceability Matrices

  • Test Plans

  • Test Reports

  • Functional and/or technical specifications

  • Data and process flow diagrams

  • Training documentation and/or work instructions

  • Other Computer System Validation documents and related systems

  • Depending on the application configure system settings and/or options.

  • Provide consultation to customers regarding enhancement/improvement of current solutions and implementation of new solutions – both systems and processes.

  • Facilitate and/or support customers in UAT planning and execution.

  • Participate in and advise roadmap discussions; be a key member of vendor assessment teams.

  • Drive resolution of business or systems issues.

  • Be a trusted partner for the Global Privacy Office, IT Security, and Business Quality teams

  • Maintain an expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, CCPA, HIPAA, SaMD, 21 CFR part 11, Article 11.


Experience Profile:

  • BA or BS in life science, informatics, business, or equivalent. MA or MS and post-graduate coursework are desirable. 

  • At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GxP, FDA 21 CFR part 11, HIPAA, SaMD & ISO 13485, Data Privacy 

  • Experience and understanding of application development methodology - including Agile and Waterfall approaches, functional requirements, process modeling and re-engineering, use case development, user acceptance testing, organizational change management, and large-scale system implementations.

  • Excellent written and verbal communication skills; able to quickly produce clearly written, well-organized documentation; excellent presentation and meeting facilitation skills.

  • Proven skills in relationship building, customer-focus, decision-making, and problem solving.

  • Demonstrated ability to quickly learn the business in unfamiliar areas.

  • Experience with and understanding of any of the following areas a plus:

  • Pharmaceutical/Biotech Good Clinical Practice (Google Cloud Platform) environment

  • Business processes around financial controls and portfolio management of large scale engineering capital projects

  • Computer systems validation


Dice Id : 10126850
Position Id : LS-BSA
Originally Posted : 2 years ago
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