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Our client, a leading pharma company is looking to engage with an IT consultant to lead the business partnering with Integrated Product Development (IPD) Regulatory Affairs / Clinical and Clinical function for digitalization initiatives. Evaluate various technologies which would help Regulatory Affairs / Clinical to automate various processes/ requirements of regulators with technical solution. Support digital strategy implementation by working with Business leads for BI, Predictive and AI planned for Regulatory Affairs / Clinical ’s. Qualify technologies available in market, work with vendor to conduct POC, ensure timely implementation of solution. Work with internal and external team to drive Digital excellence planned in Regulatory Affairs / Clinical function.
I. Evaluation of Regulatory Affairs / Clinical processes to understand potential areas for operational excellence/ process re- engineering thru digitalization -
Understand Regulatory Affairs / Clinical Processes/Domain and discuss with business owner for futuristic process simplifications / process re-engineering
Work with Functional team to understand their agenda and align technology support accordingly
Participate in various business discussions
Ensure all technology changes impacts positively on processes, people.
II. Project Planning, budgeting, forecasting and analysis -
Hold responsibility of all technology projects running across Regulatory Affairs / Clinical departments
Ensure timely closure of all the projects
Holds accountability on project Resources, Risk, budget, schedule, Quality & Cost
Create a project dossier including project plan, cash flow, resources register, risk register etc.…
III. Vendor Management
Evaluate various technology partners
Evaluate various technology solution available in market to cater Business requirements
Manage project milestones with vendor as per agreed plan
Manage vendor communication, contract, invoices, payments
Work with Vendor eco system, define appropriate escalation matrix with vendors
Ensure right delivery and appropriate payment mechanism from and for vendors.
IV. New Technology evaluation
Review peers and industry for latest technology implementation in Regulatory Affairs / Clinical domain
Evaluate and suggest newer technologies / vendor for Regulatory Affairs / Clinical
Define Scope and boundaries for technology landscape and manage pilots for Regulatory Affairs / Clinical
Arrange demos, hands-on /information about newer technologies in Regulatory
Affairs / Clinical.
V. Support Internal stakeholders for implemented solutions
Manage change in an appropriate way
Educate user community on change management
Lay down expectations with business in positive manner with no / minimum pushback for technology implementations
Ensure business continuity post implementation of the new project
Review post implementation status by surveys and such tools
Ensure timely communication with internal stakeholders.
VI. Automations & Simplifications of data using various reporting tools, Business Intelligence platforms etc.
Participate and lead digital advancement in Regulatory Affairs / Clinical
Study business function and create a blueprint for Regulatory Affairs / Clinical function
Create BI strategy for Regulatory Affairs / Clinical, in alignment with corporate business strategy.
Relevant experience and Skill:
1. 6-7 years of experience in IT, Business understanding preferably in Pharmaceuticals.
2. Having experience in Regulatory Affairs / Clinical will be an added advantage.
Leading Global Pharmaceutical Company
IT Services & Consulting
6+ years
1
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