Role - Senior Consultant
Technology - Veeva Vault / RIM /Reg 1 /CTMS
Location - London UK
Business Unit - HILDCG
Compensation - Competitive (including bonus)
Job Description
Today, the corporate landscape is dynamic and the world ahead is full of possibilities! None of the amazing things we do at Infosys would be possible without an equally amazing culture, the environment where ideas can flourish and where you are empowered to move forward as far as your ideas will take you.
At Infosys, we assure that your career will never stand still, we will inspire you to build what's next and we will navigate further together. Our journey of learnability, values and trusted relationships with our clients continue to be the cornerstones of our organization and these values are upheld only because of our people.
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Your role
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 & Or Clinical Trail management system roll out . You will create detailed functional design architecture and process artifacts and support the validation from a SME 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 /& Or CTMS and Veeva Vault platform
- Knowledge in subject area like regulatory submission process, regulatory information management systems including product registration and tracking, labelling etc. & Or 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 the submission requirements and types of submission and associated regulations pertaining to different health authorities, especially FDA and EMA
- Good Knowledge and Labeling process and systems (Above country, In country, SPL)
- 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 documentations
- Define acceptance criteria and acceptance test scenarios
- Conduct user acceptance testing
- Experience with modelling business processes, data flows, and workflow processes depicting relationships between data entities.
- Knowledge of Software Development Life Cycle processes
- A basic knowledge 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.
Besides the professional qualifications of the candidates we place great importance in addition to various forms personality profile. These include:
- High analytical skills
- A high degree of initiative and flexibility
- High customer orientation
- High quality awareness
- Excellent verbal and written communication skills
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 their continuous improvement through building and transferring digital skills, expertise and ideas from our innovation ecosystem.
Visit www.infosys.com to see how Infosys can help your enterprise navigate your next.
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