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Project Manager Optimize Publishing/Refresh CSR

Posted on Sep 17, 2019 by Coopers Group GmbH

Basel, Switzerland
IT
Immediate Start
Annual Salary
Full-Time

For our pharma client in the Basel area we are looking for a

Project Manager Optimize Publishing/Refresh CSR

Background:

The Faster Filing Program launched in 2017 as a critical strategic initiative sponsored by the PD Leadership Team. The aim of the program is to significantly reduce regulatory filing timelines from database lock to dossier submission for first filings in US and/or Europe. Each week saved in the filing process represents significant revenue and patient outcome opportunities. Faster Filing is organized into several Improvement Areas (IAs) - each with a unique and related focus to drive transformational change.

One of the IAs is 'Filing Strategy' which aims to rethink how the organization develops and applies a unique strategy for each regulatory filing based on certain characteristics and conditions (eg, which country to file in first). An initial updated strategy has been developed and the business is seeking a way to make the strategy more dynamic and actionable for each filing by developing a technology application. The Optimize Publishing IA is focused on making changes to the publishing process that transmits information to health authorities. This area of Faster Filing will involve developing a new automation technology solution and will impact existing systems. The Refresh CSR initiative is planning to transition a set of reports (incl. CSR) from the ePub solution into an Insight Publisher instance, and decommission ePub. This means to change the Clinical Study Report from a single authored document format to structured content format, support business process and technology changes.

Tasks & Responsibilities:

Facilitate requirements gathering, refinement and use case development for various Faster Filing initiatives
Engage and manage stakeholders required for system implementation and updates/enhancements to existing systems
Drive development and deployment planning for technology solutions
Prepare summary deliverables and executive presentations as needed
Create and maintain project schedule, status, issue, risk and other project management deliverables.

Must Haves:

Active project management, including planning and status reporting, RAID log maintenance as needed
Use cases creation/definition including application requirements elicitation
Solution design & application deployment, including system impact assessment and CSV validation knowledge

Start date: 07/10/2019
End date: 31/03/2020
Location: Basel area

Reference: 758221225

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