Senior Systems Specialist

Job title:

Senior Systems Specialist

Company:

GlaxoSmithKline

Job description

Senior Systems Specialist ensures that the GSK Regulatory Function maximizes the benefit it gets from its investment in IT systems and business process development by managing and optimizing the interaction between the Regulatory business groups and IT teams, both at GSK and vendors.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Report DevelopmentRelease-driven report updatesUser-requested report updates (for knowledge transferred reports)DocumentationCreation of Release NotesUAT WritingUAT Execution (replace Mateusz Miller activity)Writing Test Cycle Index/Summary DocumentsArchiving documentation to ICE/PIER/eArchiveMaintenance of Report InventoryWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Bachelor/ Master’s Degree – IT / Science / TechnicalExperience of managing/supporting regulatory business IT systems (rather than just programming them) & some experience with business system ownership and business system lifecycle managementExperience 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)Lead and participated in Business Change Teams delivering IT solutions for the businessExtensive experience of working within a regulated project delivery environment. Ability to communicate and provide assistance and support on both sides of the Business-IT interfaceProven ability to interact effectively with senior managers within the organization. Experience managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development. Experience Business Analysis and Business Process DesignFluent and able communicator in EnglishGood understanding of IT lifecycle, processes and quality managementSoftware and System Experience (any) Veeva RIMS; Power Bi report analytic tool; IBM COGNOS; CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer); Global Submit Validate – Lorenz eValidator; Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESPPreferred Qualifications:If you have the following characteristics, it would be a plus:Tech functional experience (service-level experience, platform-level experience, test team experience)Python, LogicApps, Azure ExperienceProblem solving skillsWhy GSK?What we offerPerformance with Choice – flexibility in working mode (hybrid between office (2/3 days weekly) and remote work based on employee needs)Contract of employmentEstablished job in an international, well-known pharmaceutical companyOpportunity to work in professional team playing crucial role in introducing GSK portfolio to the marketOpportunity to work within GSK standards and documentation applied globallyWide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)Flexible working hours#LI-GSK#LI-HYBRIDWhy 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, it’s 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

Poznań, wielkopolskie

Job date

Sat, 22 Jun 2024 02:39:51 GMT

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