Description
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