Senior Business Analyst (EU Clinical Trial Regulation/Regulatory requi

Basel  ‐ Vor Ort
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Beschreibung

Our client, one of the biggest pharmaceutical companies based in Basel, is looking for a Senior Business Analyst having experience with EU Clinical Trial Regulations.

This is a 6 months contracting role based in Basel and planned to start in June until the end of the year with extension opportunities!

Are you an experienced Business Analyst with knowledge of pharmaceutical industry (ie medical terminology, regulatory requirements) and currently looking for your next opportunities within one of the major innovative pharmaceutical company ?

If so, please have a look at the opportunity we can offer you:

Project background:

The new Clinical Trial Regulation (CTR) is being implemented in the EU to replace the current Clinical Trial Directive (CTD). The Clinical Trial Regulation will improve the efficiency and effectiveness of study start up and management, to shorten the overall drug development timelines.

Our client is looking for a Senior Business Analyst to support the CTRi (Clinical Trial Regulation Implementation) Program. In this role, the Senior Business Analyst will report into Workstream 4 of the CTRi program and will support the Lead Business Solution Manager to gather requirements from multiple stakeholders (Business and IT) across the organisation in order to support the multiple systems solutions implementation for the TO-BE end to end process for CTRi.

Tasks:

  • Accountable to Workstream 4 for eliciting requirements for multiple solutions to the overall program

  • Requirements organization

  • Simplifying requirements and validation

  • Requirements management (including contradictory ones) and communication

  • Requirements analysis

  • Recommend solutions

Ideal Profile:

  • 7+ years of experience in IT environment (in Regulatory domain is highly preferred) with focus on business analysis and/or resolving customer's problems

  • Knowledge of Business Analysis techniques and GxP experience

  • Customer-focused project experience

  • Proven experience with interacting effectively with colleagues at every level (eg Senior Management, customers, vendors, peers)

  • Ability to gather, document and analyze requirements

  • Ability to anticipate potential problems, determine and implement solutions, teamwork and organizational skills

  • Translate high-level requirements into high-level solutions

  • Ability to influence decision making through analysis

  • Very good communication and written skills in English

  • Openness and flexibility to work in a different time zone

Nice to Haves:

  • Knowledge of pharmaceutical industry (ie medical terminology, regulatory requirements)

  • Awareness of the EU Clinical Trial Regulation

Please note, we can only consider EU/CH candidates or those with a valid work permit for Switzerland.

Are you interested with this opportunity and would like to have more information? Please get in touch with Florence Wespiser ( (see below) ).

Please note that only shortlisted candidate will be contacted.

Start
ab sofort
Dauer
6 months
Von
Stamford Consultants AG
Eingestellt
07.06.2018
Projekt-ID:
1566968
Vertragsart
Freiberuflich
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