Systems Specialist
GSK
Poland - woj. wielkopolskie
6 d. temu

Your Responsibilities :

GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer.

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, license maintenance and lifecycle management dossiers and regulatory data management, labeling outputs.

GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

Global Regulatory Platform and Delivery (GRPD) in GlaxoSmithKline is a regulatory affairs function which brings together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management.

GRPD provides regulatory support across the product lifecycle for pharmaceutical products (clinical development to market maturity).

Systems Specialist will ensure local support for the new teams responsible for producing submissions delivered to Regulatory Authorities worldwide and for managing associated regulatory information.

Systems Specialist will manage and optimize the interaction between the Regulatory business groups and IT teams, both at GSK and vendors.

Key responsibilities :

  • Providing operational support to GRPD for Regulatory Systems,
  • Supporting a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities,
  • Providing support to local users,
  • Interfacing with IT and 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,
  • Interacting regularly with colleagues and customers at the main GRA centers in US, UK, Poland and India,
  • Supporting critical business systems.
  • Basic qualifications :

  • Bachelor in IT / scientific field,
  • Knowledge of SQL,
  • Experience of managing / supporting business IT systems,
  • 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 in Business Analysis and Business Process Design,
  • Service orientation, customer-focused,
  • Team player attitude.
  • Preferred qualifications :

  • Experience in 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),
  • Experience in managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development,
  • Good command of French (nice to have).
  • Why GSK? : We offer :

    We offer :

  • Possibilities of development within the role and company’s structure
  • Non-wage benefits (private medical healthcare, life insurance, sports card)
  • Free parking and company canteen (Poznan)
  • Attractive remuneration system
  • Career at one of the leading global healthcare companies
  • Career with purpose - whatever it is you’re doing, you’ll be sharing in our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
  • When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

    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.

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    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.

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