Senior Business Solutions Consultant
hace 7 días
Job Summary
Mod It Services is seeking an experienced Senior Business Solutions Consultant to join our team. As an IT Business Analyst - Regulatory Affairs Expert, you will play a critical role in improving complex global business processes, products, and services.
About the Role
The ideal candidate will have a strong background in Global Drug Development Regulatory Affairs and experience leading business analysis activities for solutions that redefine how companies operate. You will work on strategic initiatives to deliver solutions that bring transformative change to the business domain and enable companies to realize a competitive advantage.
Key Responsibilities
- Engage with global business associates 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 detail 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).
- Implementation experience of Veeva Submission and Submission Archive module is a plus.
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