Job Description :
Role: Business Analyst Location: Mississauga, ON Mode: Full Time Note: Profiles without CDISC, BRIDG, HL7 and other related pharma development data standards will be auto-reject Job Description: Describe different facets (Process, Data Standards, Data Migration, Technology, OCM) in the program: This program will be executed in various workstreams/squads and will require focus in multiple areas. As such analysis will be required from multiple facets (as below): Process Engineering - To be, AS IS, workflows, etc. Data Standards and Governance - Master Data, Source of truth, data profiling, mapping current data model to future data model, etc. Data Migration - Migrating from Legacy applications to future application OCM - Analyzing stakeholder impact from process, data and technology changes Technology - Configuration of industry best standards provided in COTS solution Describe Regulatory in Pharma: Regulatory in Pharma refers to Product Development Regulatory, Pharma Technical Regulatory and Drug Regulatory Affiliates group. These groups are accountable for Submissions (CTAs, INDs, MAAs, Variations, Annual Reports, etc from Roche to Health Authorities. Submission required capabilities include Planning, Tracking, Archiving, Content Creation, Publishing, Submitting to HA, Product Registration among others. Describe data, document, and content This program deals with both Data, Content and Documents. Process, Data, and Technology will deal with all three facets of the submission. Describe Business Analysis needs and Data Analysis needs Business Analyst: Analyze business scenarios that may potentially be solved by the implementation of automated systems and/or modifications to business processes. Provide expertise in the identification, evaluation, design, development, and deployment of systems and/or processes. Play key role as part of the project team or M&E in delivery of solutions that are cost-effective, sustainable, and meet business requirements. Accountable for documentation, which may include, but is not limited to: User Requirements Functional and/or technical specifications Process flow diagrams Training documentation and/or work instructions Depending on the application and/or function, may 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; a key member of vendor assessment teams Drive resolution of business or systems issues Data Analyst in terms of Data Standards and Data Migration: Translating business requirements, process documentation, system/report specifications, integrated data flows and data models into proposed data definitions, metadata specifications, and data variant/dimensional policies creating fit for purpose standards appropriately aligned with industry standards, compliance requirements and internal Data Governance policies and procedures. Working with sponsors, standards core and governance teams to define stakeholders, propose data standards and adjudicates feedback from stakeholders Previous experience in managing data and developing data standards Familiar with CDISC, BRIDG, HL7 and other related pharma development data standards Data modeling. Understands the concepts and principles of data modeling and is able to produce relevant data models across multiple subject areas. Understands industry-recognized data modeling patterns and standards and when to apply them. Knowledge of data modeling/architecture principles and techniques Data Management. Awareness of the key aspects of managing data through its lifecycle, including the understanding of data ownership, data quality, and associated data governance principles. Communicating between the technical and the non-technical. Able to listen to the needs of technical and business stakeholders and interpret them. Regularly manages stakeholders' expectations, providing proactive and reactive communication. Brings strong written and verbal communication and interpersonal skills.