Beschreibung
Regulatory Submission Publisher (m/f/d)
Reference: -en
Start: asap
Duration: 24 MM++
Main tasks:
- You will be providing first line systems and end user support e.g. incident management and service request management (including assessing, resolving or escalating technical issues)
- Facilitate communication and collaboration between RA Ops and NBS IT in matters pertaining to, RA owned applications, such as monitoring problems and summarizing activities for reporting to management
- Coordinate with 2nd level support 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 Regulatory Affairs 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.
Main qualifications
- Bachelor of Science or Master of Science degree in Computer Sciences or Life Sciences or a relevant discipline with at some years of professional work experience
- You are fluent in English (Strong oral and written skills required). Additional language is an asset
- You have profound experience in systems related 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
- 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
- Works independently and with minimal supervision and lead as needed.
Main advantages:
- You will work in an international environment
- The chance to work a fast-growing industry
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Emina Mustafic
Referencenumber:
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