Regulatory Business Process Coordinator (m/f)

Job type:
on-site
Start:
05/18
Duration:
12 MM++
From:
Hays AG
Place:
Basel-City
Date:
02/21/2018
Country:
flag_no Switzerland

Project description:
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This project is archived and not active any more.
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We are looking for a
Regulatory Business Process Coordinator (m/f)

Reference: en
Start: 05/18
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Tracking and planning team activities across all 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
  • Contributing to and potentially leading initiatives to improve process, tools and communication both within the PDMA organisation and cross-functionally


Your qualifications
  • Profound knowledge in Clinical Science, Pharmacovigilance, Biometrics, Regulatory or Operations functions within the pharma industry
  • A collaborative, supportive and engaging personality
  • A forward-looking, agile, energetic and action-oriented approach to work
  • Attention to detail and quality
  • Strong communication and organizational skills



Skills:
- Clinical data manager