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Business Admin Support (Global Regulatory Affairs)

PURPOSE OF THE POSITION

Business Admin role supports the Global Regulatory Affairs of Healthcare business.

 KEY TASKS AND RESPONSIBILITIES

•             Oversee, manage & accomplish master data obligations across the systems being under the responsibility of GRA-Ops

•             Create and maintain product families and other master data (products, indications, presentation forms, packages etc.) in line with established master data rules and processes, in particular with regards to xEVMPD and IDMP

•             Contribute to / accomplish master and meta data mapping activities

•             Participate in data cleansing activities

•             Monitor and report on compliance with the defined data quality standards

•             Oversee, manage & accomplish all support obligations (tickets) across the systems being under GRA-Ops responsibility

•             Ticket acceptance and classification, ticket resolution

•             Documentation of system changes and maintenance of system configuration log

•             Support the user community to analyze system data and provide recommendations for these analysis

•             Support the user community how to best use the systems and contribute to process-related projects

•             Contribute to Computer System Validations tasks

 

 

SKILLS AND EXPERIENCE

Work Experience

•             At least 2 years of professional experience from a Pharma enterprise or service provider, ideally in Regulatory Affairs

•             Experience in system administration support, preferably of the IT systems used in Regulatory Affairs

•             Basic understanding of the Regulatory Affairs area, including process and technology solutions

•             Demonstrated practical working experience in a GxP environment, i.e. in computer systems validation

 

Job-specific Competencies & Skills

•             Fluent command of spoken and written English

•             Specialized software skills and industry experience in Regulatory Information Management systems

•             Good organizational skills, work independently, self-motivated and proactive

•             Meticulous working style and highest quality awareness

•             Customer-orientation and service mentality

 

System Knowledge in at least in one the listed areas

•             DMS: Generis Cara

•             RIMS: Parexel Insight Manager

•             Promotional Materials: ZincMaps (soon: Veeva Promo Mats)

•             Knowledge of Veeva Vault is a plus

 

Job Requisition ID:  192067
Location:  Bangalore SBS
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

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.


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