Job Number: 3296

External 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 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.

Position- Specialist

Job Location- Electronic city Bangalore

Your Role:

Accountability/Interdependence:

• Drive regulatory & Data Quality initiatives and supports definition of data entry guidance's
• Contributes to IDMP data management activities - like O and R data management
• Independently Drive training and documentation creation as per data entry guidance's 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:

• Drive 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

Who you 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 6 years of professional experience from a pharmaceutical, service provider or IT industry setting, thereof of least 3 years in Regulatory Affairs
• Experience in Regulatory information management
• Demonstrated practical working experience in both processes (e.g. xEVMPD) and utilization 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 & drive activities independently
• 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: 213774

Location: Bangalore

Career Level: D - Professional (4-9 years)

Working time model: full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: ERP, Pharmaceutical, SAP, Data Entry, Technology, Science, Administrative

Job Number: 213774

Community / Marketing Title: GREX-0, Specialist

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