Junior Submissions Delivery Specialist
GSK
Województwo Wielkopolskie, PL
4 d. temu

Your Responsibilities :

GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies.

You’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business.

Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

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, labelling 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).

Submissions Delivery Specialist will be responsible for producing submissions delivered to Regulatory Authorities worldwide in support of the entire product lifecycle, ensuring that all submissions are produced as specified by GSK delivery teams (time and content) and are compliant with appropriate Regulator’s electronic submission standards.

Responsibilities :

  • Assemble, link and publish submission packages that meet Regulatory Authority technical standards and GSK requirements and schedules
  • Advising and assisting authors with the preparation of submission content and use of GSK document management systems and procedures
  • Check compliance of others’ work with requirements and standards
  • Maintaining knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format
  • Lead the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality
  • Interpreting and correcting technical validation errors, identifying and resolving issues with source documents, working with authors and requestors as necessary to rectify any problems that prevent completion of the publishing job
  • Regular interactions with publishing staff globally
  • Basic qualifications :

  • University Student or Graduate (preferable in scientific field or English philology)
  • Computer knowledge (e.g. MS Office, Adobe Reader, SharePoint, etc.) and preferably experience with the use of complex IT tools in a large organization
  • Fluent Polish and English (both written and spoken)
  • Paying attention to detail and ability to follow detailed procedures consistently
  • Ability to work carefully under time constraints,
  • Excellent interpersonal, communication, customer service skills
  • Demonstrate a versatile, flexible approach by adapting to challenging and changing demands
  • Ability to function as a team player within a matrixed organization
  • Preferred qualifications :

  • Work experience with tools (e.g. Adobe Acrobat, SharePoint, Documentum, Citrix, Remote desktop),
  • Experience in document management
  • Experience in fields related to regulatory affairs
  • Experience in publishing electronic submissions for a Regulatory Authority
  • Why GSK? : We offer :

    We offer :

  • Trainings and certificates
  • Great atmosphere
  • English in practice
  • Remote work
  • Work-life balance
  • Integration events
  • Stability of employment
  • Sport and recreation package
  • Private medical coverage
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