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Project Manager (m/f)

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For our client, a well-known pharmaceutical company located in Basel region, we are looking for an ambitious Project Manager (m/f).

Project Manager (m/f)

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 (e.g., 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

General information

  • Start date: 07.10.2019
  • Latest start date: 14.10.2019
  • End date: 31.03.2020
  • Extension: Possible
  • Work location: Basel region
  • Workload: 100%
  • Remote/Home Office: 1 day possible after clarification
  • Travelling: Not planned, but maybe for a workshop (Poland)
  • Team Size: 2 project teams with 8 to 10 members

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

Nice to Haves

  • Pharma and Genentech experience 
  • Regulatory business or informatics background
We are able to offer you diversified responsibilities in a professional and dynamic international team, performance-matched benefits, and a friendly work environment.

Address

Datalynx AG
Frau Valbona Krasniqi
Administrative Assistant
Steinengraben 22
4051 Basel
+41 61 500 01 77

Website https://www.datalynx.com/de

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