Site Name: Bengaluru Luxor North Tower
Posted Date: Jun 20 2024
Key Responsibilities

• Provide operational support to GRC for Regulatory Systems
• Support a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
• Provide first line support to global users
• Interface with IT, Business System Owners to coordinate solutions delivery and support.
• Contributing to development of project proposals and business cases.
• Providing and coordinating the business engagement in projects in collaboration with IT and Business Project Teams.

Education Requirements

• Minimum: Bachelors Degree in IT / Science / Technical area of specialization
  Reason: Working in complex technical environment within a scientific organization
• Bachelor degree in scientific or technical area of specialization
  Reason: The ability to interact confidently with highly-educated staff, customers and partners in a complex technical environment will be a significant advantage in this role

Job Related Experience Experience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems). Participate and Lead Business Change Teams delivering IT solutions for the business. Solid foundation of working within a regulated project delivery environment. Ability to communicate and provide assistance and support on both sides of the Business-IT interface. Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development. Experience Business Analysis and Business Process Design.
It is essential that the candidate has experience of managing/supporting regulatory business IT systems (rather than just programming them). Some experience with business system ownership and business system lifecycle management. Other Job-Related Skills

• Fluent and able communicator in English.
• Service orientation, customer-focused
• Good team worker
• Software and System Experience (any)
  • Parexel Insight Manager - RIM and Cognos Reporting
  • Documentum D2 - Labeling System
  • CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)
  • Global Submit Validate - Lorenz eValidator
  • Axway eSubmission Gateway - FDA Web Trader, EMA Gateway CESP
  • Veeva Regulatory Vault
  • PowerBi
  • SharePoint

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in gsk.com, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.