Global Technical Regulatory Business Administrator
Start date: 19/03/2018
End date: 31/12/2018
- 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
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