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Global Technical Regulatory Bu...

Global Technical Regulatory Business Administrator

Michael Bailey Associates Limited Careers
Position Information
  • Job Category: Naturwissenschaft/Forschung
  • Occupation: Forschung & Entwicklung
    sonstige Berufe - Naturwissenschaft/Forschung
    Pharmazeutische Forschung
  • Career Level: Berufserfahren
  • Industries: Biotechnologie/Pharma/Medizinaltechnik
  • Education Level: Nicht spezifiziert
  • Reference Code: 118541_1520860257
  • Name: Darya Koblik
  • Company
  • Location
  • Job Status/Type
    Vollzeit Freie Mitarbeit/Dienstvertrag/Projekt
  • Twitter

For our life science client we are currently looking for a

Global Technical Regulatory Business Administrator

Start date: 19/03/2018
End date: 31/12/2018
Location: Basel

Main tasks:

- 1st level support for DRA end users ( incident and service request management, resolving or escalating technical issues, user management)
- Provide information to 2nd level support,
- Create Service Request and Incidents reports.
- Facilitate communication between departments (regular system updates, initiating enhancement requests and summarizing activities for reporting to management with some supervision).
- Participate in changing regulatory requirements and the related business processes, to ensure proper knowledge transfer for system enhancement requests.
- Participate in validation and implementation activities for system upgrades and functionality enhancements.
- Develop or comment on User Requirement Specifications, Functional Specifications, administrative procedures and working instructions, and ensure implementation.
- Global communication and interaction with colleagues worldwide (global input on above mentioned documents).
- Provide user training for DRA end users.

Ideal candidate shall bring:

- Experience as Business Analysts or 1st level Application Support.
- Experience in Regulatory, IT, QA, TechOps or CMC.
- 3+ years experience working with document management systems or publishing software used in the pharmaceutical industry.
- Experience working with a ticketing, remedy system.
- Experience working in pharma, understanding of validation.
- Experience with eCTD submissions and XML technology is a plus
- PC desktop environment, Microsoft suite, Windows, Adobe Acrobat.
- Training and/or experience in 21 CFR Part 11 requirements for electronic records, electronic signatures.
- Knowledge of Health Authority submission formats, drug development process and the related document requirements.
- University degree in computer science or business management (or equivalent).
- Ability to run a small project team.
- Ability to work under pressure of time
- Very good communication skills
- Fluent English

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

About us

For over 25 years, we have been helping global clients understand their workforce, designing, managing and implementing projects and solutions allowing them to unleash their full potential.

How do we do it? We find and employ the best, focus 100% on the client and work hard. Client service is the foundation of our success; our people are passionate about delivering outstanding results, time and time again.

More than just a supplier, we are a partner to leading companies operating in the IT, Telecommunications, Finance, Oil and Gas and Pharmaceutical sectors with offices across Europe and Asia Pacific.

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