Senior Business Analyst

Recruiter
Roche
Location
Hertfordshire
Posted
10 Oct 2018
Closes
17 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
As Sr. Business Analyst for Regulatory Informatics, you play a fundamental role in designing the next generation of information-centric solutions that will support Pharma Development (PD) and Pharma Technical (PT) Regulatory, 100+ global DRA affiliates, and the Pharma Informatics (PI) organisation. As Sr. Business Analyst you will play a pivotal role in ensuring that the needs of our customers in the Regulatory groups are elicited, understood, clearly documented, verified and translated into meaningful and value adding business solutions. You have a hunger for innovation and an interest in topics such as design thinking, agile development, usability engineering and put quality at the heart of all you do. You are not intimidated by ambiguity and have strong critical thinking and problem solving skills. Your main responsibilities are:Preparing the project charter and other mandatory deliverables supporting the Project Management Methodology (PMM) “initiate” and “define” phases together with the Informatics Project Manager (IPM) Eliciting User Requirements (URS) and Functional Requirements (FS) on the basis of identified business needsProviding support to key business users and stakeholders to support “As Is” and “To Be” business process analysisMapping of information flows across business processes and systems in order to drive data standardizationDefines and engages stakeholders and represents their interests along with overarching business needs and thinking to ensure fit for purpose solutionsTaking responsibility to ensure that the final solution meets the user requirements and meets the customer's needs and supports operational services teams in ensuring continued business value realization and business adoptionFacilitating the preparation and execution of user acceptance testing (UAT) with key business users and stakeholdersParticipating in the annual budgeting and business case development with an understanding of how to estimate resources and effort for new project proposalsBe a key contributor to the PxR strategic roadmapCoach and support other Business Analysts or team membersAble to support high profile strategic programs like ISO IDMP, EU Clinical Trial Regulation, and Regulatory Digital StrategyYou have a Bachelor’s degree in Computer Science, Life Sciences or an extensive amount of business analysis experience in multiple areas of business domain and technology or related field experience with Health Authority / Regulatory Authority. You bring the following qualifications:Proficient knowledge of pharmaceutical Regulatory processes, including knowledge and appreciation of scientific Regulatory affairs, ethical and compliance principles Proficient experience in the area of Regulatory Affairs including the associated application landscape, with good knowledge of Regulatory industry standards desired Strong systems, user and functional requirements analysis and technical skills and proven skills in document authoring under Computer Systems Validation processes, (e.g. User Requirements Specification, Functional Specifications) Formal training and proficiency in software development methodologies and computer systems validation in regulated industries (biotech/pharma), and formal process training (e.g. Six Sigma, IIBA Certification) would be a plus Excellent presentation, meeting facilitation and communications skills (written and verbal in English, other languages are plus) and ability to work outside the standard office hours and according to different time zones as required, as well as to travel as required up to 15% of the timeHighly desired if you have a background in data analysis with an understanding of information flow methods (CRUD) and master data management principles including data standards and master data governance Roche is an equal opportunity employer.Information Technology, Information Technology > IT Business Process Analysis

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