Regulatory Affairs Publisher- specialist
Posted on Oct 28, 2020 by Michael Bailey Associates - Zurich
An exciting opportunity has opened up for a regulatory affairs specialist for publishing and regulatory operations department. This is 12 months contract based in Switzerland, Basel.
Facilitate communication and collaboration between RA Ops and IT in matters related to RA owned applications, such as monitoring problems and summarizing activities for reporting to management.
Coordinate with IT department to address escalated System issues.
Prepare user manuals, working instructions and training materials as appropriate, ensure training are recorded and records maintained in the relevant quality system.
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.
Liaise with internal stakeholders to map business models, existing systems and establishes scope, business priority for change initiatives of small and medium size and complexity.
* BS or MS degree in Computer Sciences or Life Sciences or a relevant
* Prior experience in Pharma (preferably in a Regulatory environment) or related industry.
* Working knowledge with RA relevant computer programs and systems with demonstrated ability to learn and train others on new systems quickly.
* Effective interpersonal skills with abilities in customer service to interact with individuals at various levels of the organization.
* Demonstrated team player, collaborative, people smart and willing to learn.
* Ability to perform under time pressure; highly motivated, and flexible.
* Ability to plan and prioritize workload.
* 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.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.