IDMP Senior Specialist

Posté 10 mars 2022

Bangalore, Karnataka - India

Demander un identifiant 243297

Détails

 

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.

 


Your Role:

• Participates in Regulatory Data Quality initiatives and supports definition of data entry guidances
• 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 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
• Provides support, training and end user communication for data management topics
• Contributes to migration and 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
• 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

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

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

 

Who your are:

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
• 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

 


 

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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