Beschreibung
Background:
The Publishing Technology Readiness Project will address a compliance risk in regulatory submissions and will prepare the Regulatory Submissions Group (RSG) to meet global health authority requirements with industry-standard [or industry-leading] technology. This project will implement an updated version of Insight Publisher and Insight for Viewing to avoid compliance risk for those business-critical applications.
We are looking for a Professional Technical Lead/Engineer to support the Publishing Technology Readiness Project. In this role, the Technical Lead/Engineer will support technical upgrades in our eSubmission system landscape.
General information:
- Start date: ASAP
- Latest start date: 01.11.2019
- End date: 31.03.2020
- Work load: 100%
- Work location: Kaiseraugst
- Remote: Needs to be discussed
- Team: Virtual cross-functional global team
Tasks and Responsibilities:
- Implementation and qualification of software component in Regulatory (Submission Management) area
- Close collaboration with internal and external partners like Business Partners, Informatics, Engineering and Suppliers
- Support in upgrading Insight Publisher and Insight for viewing from Parexel
- Capable to perform technical upgrade of software components
- Capable to update specification documents to ensure compliance with CSV and Validation requirements
- Recommend solutions
- Proactive investigation of issues
Summary of responsibilities:
- Provides input into the configuration of the eSubmission system
- Provides support for the execution of POCs
- Manages the infrastructure to ensure that all the required servers and environments are in place in a timely manner
- Liaise with the vendor for issue reporting and resolution
- Works with vendor to successfully manage any deployments
- Works with Test Lead on the testing approach
- Maintains Technical System Design and Configuration Specifications
- Liaise with Infrastructure Support Group and vendor for maintenance of the Technical System Specifications and the development of IQ/OQ procedures and the installation of test and production environment against these
- Assists in the evaluation and resolution of any errors found during testing
Must Haves:
- 5+ years of relevant experience in supporting IT systems in regulatory (submission management) area ****
- Windows Server OS, Active Directory, File Share and Oracle DB in a large organization ****
- CSV and experience working with validated systems ****
- Oracle DB scripting and installation of different applications ***
- Insight Publisher and Insight for viewing from Parexel***
- Knowledge of pharmaceutical industry (i.e. medical terminology, regulatory requirements) **
- Fluent in English
- Problem solving & proactive attitude, team player and self-organized, can-do attitude and analytical mind
- Great customer focus skills and attention to details (proactive, communicative and a “thinker”)
- Openness and flexibility to work in a different time zone, working with global and distributed teams
- Ability to anticipate potential problems, determine and implement solutions, teamwork and organizational skills
- Be prepared to work outside the standard office hours and according to different time zones as required
- Great team player