For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Regulatory Submission Support
- Provide first line systems and end user support e.g. incident management and
service request management (including assessing, resolving or escalating
- Facilitate communication and collaboration between Regulatory Operations and IT
- Coordinate with 2nd level support to address escalated System issues.
- Prepare user manuals, working instructions and training materials as appropriate
- Participate in RA project initiatives involving, but not limited to, requirements
gathering and analysis, migration, and deployment activities.
- Participate in validation and implementation activities for system upgrades and
functionality enhancements as appropriate.
- BS or MS degree in Computer Sciences or Life Sciences or a relevant discipline with at least 2-7 years of professional work experience. Master's degree preferred.
- Fluent in English (Strong oral and written skills required). Additional language is an asset.
- Experience: 2-7 years systems related experience in Pharma (preferably in a Regulatory environment) or related industry. .
- Working knowledge with RA relevant computer programs and systems
- Effective interpersonal skills with abilities in customer service to interact with individuals at various levels of the organization.
- Basic knowledge of the worldwide Health Authority submission formats as well as the overall drug development process and related document requirements is desirable
- Knowledge and experience with eCTD, IDMP, Publishing Standards and applicable related tools is desirable
- Knowledge of ticketing tools, validation tools and concepts of GxP Software Development and testing is desirable.
Place of work: Basel
Duration: 1 year
Please apply online. For further information about the position, please contact: Mrs Diana Steinhauer (+41 61 270 80 16).