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Senior Manager RIMS (m/f) and Backup System Owner

Posted 13 Nov 2017

Darmstadt, Hesse - Germany

Req Id 166370

Details

A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

 

Based on your in-depth expertise on both regulatory processes and standards as well as your RIMS systems capabilities you provide business consultancy work and support to our internal customers from various business divisions worldwide. You deliver to our customers what they need, i.e. the correct and fit-to-purpose translation of regulatory activities into system functionalities. Also, you contribute to our activities on sustainable data quality improvements by implementing improved trainings, data entry processes and process documentation. In addition, you contribute as backup of the system owner to our cross-functional projects (e.g. IDMP) and to the selection and implementation of the Regulatory end-to-end systems platform. You ensure that the future – merged – submission processes for dossiers (eCTD, eAF, CESSP) and product information (xEVMPD, IDMP) are properly taken into account in our systems that are built now and in the next years.

 

Who you are:

 

  • At least 5 years of experience in Regulatory Operations
  • Demonstrated experience in Regulatory Information Management Systems and system management
  • Expert understanding of external regulations related to Regulatory data and current and upcoming eSubmission requirements and technical means, e.g. xEVMPD, IDMP, eAF or CESP
  • Fluent English
  • Work independently, self-motivated
  • Goal-oriented, pragmatic, meticulous working style, high attitude to quality
  • Strong service mentality
  • Excellent communication skills

What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

Apply Now

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