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Senior Specialist Veeva Vault RIM

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

 

Accountability/Interdependence: 

• Participates in Regulatory Data Quality initiatives and supports definition of data entry guidances
• Contribute to compliance activities in VEEVA Vault
• Contributes to IDMP data management activities - like P, O and R data management & Data Catelogue
• Contributes to training and documentation creation as per data entry guidances and system functionalities in VEEVA Vault
• 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 or xEVMPD
• Provides support, training and end user communication for data management topics
• Contribute in data verification topics
• 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 in VEEVA Vault
• 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

 

Cooperation Internal:

• All functions within GRA&RDQ
• All functions across R&D contributing to regulatory data and information 
• All functions within Merck Healthcare and Life Science contributing to regulatory data and information 

 

Cooperation External:

• Interaction with regulatory agencies (esp. EMA) on behalf of Merck for data-focused discussions about e.g. xEVMPD compliance

 

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 8 years of professional experience from a pharmaceutical, service provider or IT industry setting, thereof of least 6 years in Regulatory Affairs
• Experience in Regulatory information management & VEEVA Vault RIM
• Demonstrated practical working experience in both processes (e.g. xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA)

 

Job specific Competencies & Skills:

• Good understanding of Regulatory Affairs business processes
• Regulatory Information management & VEEVA Vault RIM experience
• Good understanding of both processes (e.g. xEVMPD) and systems (e.g. RIMS, VEEVA)
• 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

 

 

 

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

 

Job Requisition ID:  245747
Location:  Bangalore
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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