Regulatory Business Process Coordinator (m/f)

REFERENZNUMMER:

366711/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Clinical data manager