Senior Manager - Digital Transformation - Regulatory Affairs/Clinical Functions

Job purpose :

- Lead the Digital transformation 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.

KRA :

I. Evaluation of Regulatory Affairs / Clinical processes to understand potential areas for operational excellence/ process re-engineering thru digitalization

II. Project Planning, budgeting, forecasting and analysis

III. Vendor Management

IV. New Technology evaluation

V. Support Internal stakeholders for implemented solutions

VI. Automations & Simplifications of data using various reporting tools, Business Intelligence platforms etc

Detailed role :

- 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.

- 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

- 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

- 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

- 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

- 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:

4-10 years of experience in IT, Business understanding preferably in Pharmaceuticals. Having experience in Regulatory Affairs / Clinical will be an added advantage