Regulatory Compliance Information Specialist

Posted 26 Sep 2019

Bangalore SBS, Karnataka - India

Req Id 198311

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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:

  • Contribution as Subject Matter Expert with dedicated business process know how for Regulatory Information Management and Standards to our cross-functional projects and strategic initiatives like IDMP as well as the implementation of Veeva Vault
  • Ensure data governance rules (master/meta data dictionaries, processes and data flow across multiple applications) are implemented and followed to achieve as well as maintain global data consistency of IDMP related applications and systems (RIMS, xEVMPD, IDMP):
    • Define data quality measures for data entry and data maintenance processes and manage evaluation of data quality
    • Define and implement reports and controls to verify and monitor regulatory data quality
    • Conduct and support data quality activities like data migration, data verification, data completion, or data clean-up/correction incl. xEVMPD/IDMP maintenance
    • Monitor and report on compliance with defined data quality standards
  • Ensure that the future – merged of Regulatory Data (e.g. xEVMPD, IDMP, ePI) and dossier submission processes (eCTD, eAF, CESSP, EU-CTR) are properly taken into account in organization processes.
  • Consolidate corrective action plans to improve regulatory data quality
  • Partner with GRA and other functions, departments and divisions for regulatory data management related topics
  • Provide support, documentation, training and end user communication for regulatory data management related topics
  • Provide data management methodology knowhow to support the processes in GRA OPS
  • Support user community to analyze system data and provide recommendations for these analysis
  • Export and extract system data and provide ad hoc reports as required

 

 

Who you are:

  • At least 5 years of experience from a pharmaceutical industry or service provider with strong business focus
  • At least 3 years in Regulatory Affairs with a knack for data management
  • Excellent data management experience including data governance and master data management
  • In-depth expertise on both regulatory processes for submission of data and documents for medicinal products (e.g. xEVMPD, IDMP, IND, CTA, MAA, lifecycle management) and utilisation of regulatory systems (RIMS, DMS, SAP)
  • Experience in Veeva Vault is a plus
  • Fluent English
  • Work independently, self-motivated
  • Goal-oriented, pragmatic, meticulous working style, high attitude to quality
  • Agile mindset and change oriented
  • Strong service mentality
  • Excellent communication skills

What we offer:  With us, 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 https://jobs.vibrantm.com

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