Job details
Country: United Kingdom
State / Region / Province: London
Work Location: London
Domain: Delivery
Interest Group: Skills
Company: ITL UK
Requisition ID: 126188BR
Role: Senior Consultant
Technology: Veeva Vault / RIM / Reg 1 / CTMS
Location: London UK
Business Unit: HILDCG
Compensation: Competitive (including bonus)
Job Description: In the role of a Senior Consultant, you will be a key player in the consulting team that helps discover and define Veeva Regulatory Information Management system and Clinical Trial Management System rollout. You will create detailed functional design architecture and process artifacts and support the validation from a Subject Matter Expert perspective and involve in user acceptance. You will also support knowledge transfer with the objective of providing value-adding consulting solutions that enable our clients to meet the changing needs of the global landscape.
Required: Good hands-on work experience in configuration of Veeva RIM/Reg 1 / CTMS and Veeva Vault platform.Knowledge in subject area like regulatory submission process, regulatory information management systems including product registration and tracking, labeling, etc. & knowledge in CTMS.Good knowledge of business processes in EVMPD/IDMP / Product License Tracking (small molecules/Med devices/biologics).Good exposure to regulatory document/content management systems and submission authoring assembly of eCTD / Chemistry Manufacturing Control (CMC) including hands-on exposure to the submission requirements and types of submission and associated regulations pertaining to different health authorities, especially FDA and EMA.Good knowledge of labeling processes and systems (Above country, In country, SPL). Preferred: Good Business Analysis skills covering ability to understand the client's business problems, elicit requirements by having meaningful and probing discussions with the business contact.Convert the requirements into user stories/use case documentation.Define acceptance criteria and acceptance test scenarios.Conduct user acceptance testing.Experience with modeling business processes, data flows, and workflow processes depicting relationships between data entities.Knowledge of Software Development Life Cycle processes. Advantage: A basic knowledge of writing custom queries in SQL or PL/SQL is needed for data extraction and validation.Expertise in the full System Development Life Cycle (SDLC) on a variety of technologies and platforms. Personal: High analytical skills.A high degree of initiative and flexibility.High customer orientation.High quality awareness.Excellent verbal and written communication skills. About Infosys: Infosys is a global leader in next-generation digital services and consulting. We enable clients in 50 countries to navigate their digital transformation. With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through the many next of their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.
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All aspects of employment at Infosys are based on merit, competence, and performance. We are committed to embracing diversity and creating an inclusive environment for all employees. Infosys is proud to be an equal opportunity employer.
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