Senior Business Process Manager Regulatory Information Management Rim H/F Ecaris

What they need

Client context

The client is a major international pharmaceutical group and a leading Life Sciences player, whose Regulatory Business Operations organisation drives the consistency, operational performance and continuous improvement of regulatory processes worldwide. This organisation relies on a structuring Regulatory Information Management (RIM) environment that brings together the regulatory business teams, the team in charge of day-to-day RIM operations (RIM Business Run), the data entry teams, business experts and process owners, data experts, the IT teams in charge of application run, as well as the group's local affiliates at both global and local level.

Assignment context

The consultant will work within the group's Regulatory Business Operations organisation, supporting the global Regulatory Information Management (RIM) environment. He/she will act as a key interface between the regulatory business teams, the team in charge of day-to-day RIM operations, the data entry teams, business experts and process owners, data experts, the IT teams in charge of application run and the group's local affiliates, both in France and internationally.

This is first and foremost a business- and functionally-oriented RIM assignment, not a Veeva development or technical configuration assignment. The consultant must be able to quickly get up to speed on the group's RIM configuration, its business processes, the roles and responsibilities involved, and the way regulatory data and documents flow across the organisation. A key component of the role is to determine whether an issue originates in the business process, the data, the system configuration, the application behaviour or user practices.

The assignment therefore sits at the crossroads of Regulatory Operations, Business Process Management, RIM systems and regulatory data, with the objective of ensuring the consistency, operational efficiency and continuous improvement of the regulatory processes supported by the group's RIM environment.

Assignment objectives

The assignment aims to translate the business needs of the Regulatory function into concrete process and system improvements, while ensuring the continuity and quality of day-to-day operations. In this capacity, the consultant will:

- Ensure the consistency, operational efficiency and continuous improvement of the regulatory processes supported by the RIM environment;

- Translate the business needs of the Regulatory function into actionable process and system changes;

- Support day-to-day business operations and contribute to RIM release cycles and user acceptance testing (UAT) activities;

- Contribute to improving the quality of regulatory data;

- Provide business expertise in support of document and archive migration activities.

Assignment Scope, Consultant Responsibilities and Expected Deliverables

Assignment scope

The scope covers the entire lifecycle of the regulatory processes supported by the RIM environment, with a strong Global/Local dimension. It includes in particular:

- Planning and tracking of regulatory changes, at both global and local level;

- Planning and tracking of regulatory submissions and registrations;

- Regulatory lifecycle management, including variations and renewals;

- Tracking of the CCDS (Company Core Data Sheet) and Local Labeling;

- Regulatory reporting, key performance indicators (KPIs) and milestone tracking;

- The Veeva Vault RIM functional environment, in particular the Vault Registrations, Vault Submissions and Submissions Archive modules;

- Business support to document and archive migration activities, in coordination with the teams in charge of these migrations.

The consultant will also need to understand how global regulatory processes cascade down to local affiliates, and how a product, registration, submission or labeling change can trigger cascading impacts across countries and markets.

Consultant responsibilities

On a day-to-day basis, the consultant will work closely with the RIM Business Run and data entry teams to investigate and resolve process-related tickets raised by a wide range of stakeholders. His/her responsibilities will include in particular:

- Investigating and resolving process-related tickets (process questions, user issues, role or workflow ambiguities, data inconsistencies, reporting issues, interactions between regulatory processes);

- Performing root cause analyses, so as not to merely handle tickets one by one but to identify recurring issues and determine the appropriate response: process clarification, user support, data remediation or system change;

- Gathering enhancement requests from business experts and process owners and turning them into clear, structured and actionable Change Requests for the IT teams in charge of application run, including understanding the underlying need, challenging proposed solutions where necessary, assessing impacts and dependencies, documenting requirements and defining appropriate acceptance criteria;

- Actively contributing to the prioritisation and planning of RIM releases, assessing their business impact, taking part in functional validation and representing the business during user acceptance testing (UAT) activities;

- Contributing to process documentation and knowledge management by drafting or improving process guides, user guides, work instructions, FAQs and targeted communications, and determining the most appropriate communication channel (Q&A sessions, knowledge-sharing initiatives, newsletters or direct communication to the relevant user communities).

Expected deliverables

The assignment will result in the following deliverables:

- Business tickets investigated and resolved, together with documented root cause analyses;

- Structured Change Requests, with documented requirements and defined acceptance criteria, for the IT teams;

- Documented contributions to the prioritisation and planning of RIM releases, as well as to functional validation and user acceptance testing (UAT) activities;

- Updated process documentation, user guides, work instructions, FAQs and communication materials;

- Documented business input to document and archive migration activities, ensuring that migration rules are consistent with current regulatory processes.