Regulatory Business Process Coordinator - Pharma

Reference Number: 895941-W
Type of placement: Contract, Contract, 12 + months, high chances of extension
Location: Switzerland, North West

Introduction:

Based in Basel, this position in the Regulatory Business Processes team offers the opportunity to work in a highly collaborative cross-functional environment, preparing and contributing information for inclusion in periodic Safety Regulatory documentation.

The Business process Coordinator will be responsible to manage, source, assemble and prepare information regarding the use of products within clinical trials, on behalf of Global Medical Affairs and Affiliates.

Main Responsibilities:

  • Tracking and planning team activities across all the company products
  • Requesting and obtaining supporting information (trial description, clinical documentation, patient level data) from Affiliates and Global Medical Affairs teams
  • Reconciling information from multiple sources, in order to ensure quality and consistency of information to be reported
  • Determining the scope of trials that are to be included in each report
  • Producing summaries of relevant data from clinical trials – for example: cumulative exposure, demography, deaths and withdrawals due to adverse event
  • Clarifying process questions, and providing guidance
  • Liaising and collaborating with Affiliates, Global Medical Affairs teams, and other teams within Regulatory, Safety, Clinical Science and Biometrics functions

Qualifications and Experience:

  • Bachelors / Masters level Scientific degree
  • 5 + years of experience in Biometrics, Operations, Clinical Science or Regulatory
  • 5 + years of experience, working within the Healthcare / Pharma environment functions, within the Pharma industry
  • Knowledge of clinical trial documentation such as Protocols and Clinical Study Reports
  • Experience with clinical trial management systems and trial-level data
  • Knowledge of clinical trial databases and patient-level data
  • Collaborative, supportive and engaging approach with people
  • Action-oriented approach to work
  • Strong communication and organizational skills
  • Fluency in written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

 

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