Senior Consultant-Veeva Vault / RIM / Reg 1 / CTMS

Technology – Veeva Vault / RIM /Reg 1 /CTMS

At client, 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.

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)

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 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

Advantage:

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.

Personal

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