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Global Business Process Consultant
hace 2 meses
Role Summary:
The Healthcare Businesswomen's Association seeks a seasoned Senior Business Analyst - Regulatory Affairs to lead business analysis activities for solutions that redefine how we operate. This role purpose is to act as a consultant and advisor, providing guidance to improve complex global business processes, products, and services.
Key Responsibilities:
- Engage with global business associates and leverage the appropriate teams and functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
- Analyze the business domain and author business requirements. Coordinate and facilitate ongoing reviews of business processes.
- Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support the validation and testing as appropriate.
- Flag issues/ changes/ risks to the Project Manager and workstream leads.
- Work together with a product squad in delivering the Product's roadmap. Actively participate in sprint planning discussions and ensure sprint functional deliverables (prioritized backlog, user stories completed and demonstrated etc.) are on track.
- Liaise with vendor, internal IT teams and business to ensure documentation is at the appropriate level of details and that the requirements are accurately interpreted and implemented.
- Act as interface between business and Implementation partners.
- Review the sprint demos and ensure that gaps are documented.
Requirements:
- Bachelor's degree in engineering or pharmaceutical discipline. An advanced degree (MBA, MS etc.) and related accreditations (IIBA, Veeva, Agile certifications etc.) is a plus.
- 7+ years of IT Business Analysis experience with excellent communication skills.
- Must have proven strong knowledge of SDLC, Validation & Compliance.
- Proficiency with tools such as Jira, Confluence, HPQC, Business process modelling tools.
- Experience in Data migration and System integration related projects.
- Multi-national global experience in interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority.
- Experience in Regulatory Affairs business processes is a plus (e.g. Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labelling).
- Desirable: Implementation experience of Veeva Submission and Submission Archive module is a plus.
- Experience in Managing GxP Projects and Related Fields is a plus.
