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GREX-0, Sr Analyst

1.00 to 3.00 Years   Bangalore   24 Dec, 2020
Merck Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaStatistics / Analytics
EmploymentTypeFull-time

Job Description

A career at our company is an ongoing journey of discovery: our 57,000 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.Accountability/Interdependence:

  • Participates in Regulatory Data Quality initiatives and supports definition of data entry guidances
  • Contributes to IDMP data management activities - like O and R data management
  • Contributes to training and documentation creation as per data entry guidances and systems functionalities
  • Partners with Global Regulatory Affairs and other functions, departments and divisions for process and data quality topics as well as IDMP related topics
  • Monitors and reports on compliance with the defined data quality standards
  • Participates in data cleansing activities related to data quality initiatives, data migrations or xEVMPD
  • Ensures compliance to health authority requirements on data submissions
Impact:
  • Supports implementation of data governance for Global Regulatory Affairs and beyond
  • Ensures adherence to data quality principles for regulatory data
  • Contributes to define the strategy of the Regulatory Compliance & Regulatory Information Management Department
  • Liaise with Health Authorities on data submission topics (e.g. xEVMPD)
Complexity:
  • Supports cross-functional or cross-business projects and strategic initiatives
Education:
  • Basic degree in a scientific discipline or related work experience in the chemical-pharmaceutical industry
  • Regulatory information management and pharma IT background
  • Good knowledge of current regulatory data standards
  • Fluent command of spoken and written English
Work Experience:
  • At least 4 years of professional experience from a pharmaceutical, service provider or IT industry setting, thereof of least 2 years in Regulatory Affairs
  • Experience in Regulatory information management
  • Demonstrated practical working experience in both processes (e.g. xEVMPD) and untilisation of regulatory systems (RIMS, DMS, SAP)
Job specific Competencies & Skills:
  • Good understanding of Regulatory Affairs business processes
  • Regulatory Information management experience
  • Good understanding of both processes (e.g. xEVMPD) and systems (e.g. RIMS, DMS, SAP)
  • Results-driven and pragmatic approach to work
  • Good organizational skills, self-motivated and proactive
  • Meticulous working style and high attitude to quality
  • Good stakeholder management and communication skills
  • Strong service mentality
  • Quick comprehension, good analytical and problem solving skills
  • Ability to work in a virtual and matrix environment
Job Location- Electronic City, Bangalore 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,

Keyskills :
data entrydata qualitydata cleansingdata managementproblem solvingdata governanceregulatory affairsworking experiencequality initiativesregulatory complianceinformation management

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