GSK

Regulatory Specialist, Labelling Coordinator

GSKO firmie

Rekrutacja zdalna

Rekrutacja zdalna

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Rekrutacja zdalna

GSK

Grunwaldzka 189

Poznań

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

Within GRPD, the Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our company core datasheet, which contains information for prescribers and patients. The post holder is accountable for providing operational support to the labelling team and will be responsible for the quality and accuracy of their own work.
Regulatory Specialist, Labelling Coordinator
Workplace: Poznań
256160

Responsibilities:

  • Provide support to Labelling Staff to help ensure quality and consistency of global/regional/country product information (PI) documentation development and maintenance.
  • Management of Labelling data in GSK databases and systems including coordination of supplementary requirements for Global PI dispatch. Ensure information is correctly captured to agreed schedules
  • Management of EU PI annexes for products registered via the EU centralised procedure, including coordination of translations during linguistic process, interaction with LOCs and submission to EMA.
  • Coordination of Country Labelling Differences and periodic reports, and management of labelling artwork in accordance with relevant processes, templates and standards
  • Supporting GRA-Labelling process and systems in accordance with GSK policies and procedures
  • Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.

Basic qualifications:

  • Previous experience in regulatory/ clinical trials operations or other life science related fields.
  • Bachelor's or Master's degree in scientific or technical field (e.g. chemistry, biotechnology, pharmacy, biology or equivalent).
  • Experience of working with documentation, databases, data management systems.
  • High orientation to details and accuracy.
  • Ability to work carefully under time constraints.
  • High communication skills, teamworking attitude.
  • Very good computer skills (work experience with complex computer systems and databases).
  • Fluent Polish and English (both written and spoken).

Additional requirements:
  • Work experience in an international environment would be an additional advantage.

We offer:

  • Interesting job in one of the leading global healthcare companies.
  • Cooperation with an international environment where you can have an access to cutting-edge technology and work in a friendly atmosphere.
  • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
  • Corporate culture based on our values: patient focus, integrity, respect and transparency.
 


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

Within GRPD, the Labelling team supports our portfolio of medicines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our company core datasheet, which contains information for prescribers and patients. The post holder is accountable for providing operational support to the labelling team and will be responsible for the quality and accuracy of their own work.
Regulatory Specialist, Labelling CoordinatorNumer ref.: 256160

Responsibilities:

  • Provide support to Labelling Staff to help ensure quality and consistency of global/regional/country product information (PI) documentation development and maintenance.
  • Management of Labelling data in GSK databases and systems including coordination of supplementary requirements for Global PI dispatch. Ensure information is correctly captured to agreed schedules
  • Management of EU PI annexes for products registered via the EU centralised procedure, including coordination of translations during linguistic process, interaction with LOCs and submission to EMA.
  • Coordination of Country Labelling Differences and periodic reports, and management of labelling artwork in accordance with relevant processes, templates and standards
  • Supporting GRA-Labelling process and systems in accordance with GSK policies and procedures
  • Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.

Basic qualifications:

  • Previous experience in regulatory/ clinical trials operations or other life science related fields.
  • Bachelor's or Master's degree in scientific or technical field (e.g. chemistry, biotechnology, pharmacy, biology or equivalent).
  • Experience of working with documentation, databases, data management systems.
  • High orientation to details and accuracy.
  • Ability to work carefully under time constraints.
  • High communication skills, teamworking attitude.
  • Very good computer skills (work experience with complex computer systems and databases).
  • Fluent Polish and English (both written and spoken).

Additional requirements:
  • Work experience in an international environment would be an additional advantage.

We offer:

  • Interesting job in one of the leading global healthcare companies.
  • Cooperation with an international environment where you can have an access to cutting-edge technology and work in a friendly atmosphere.
  • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office).
  • Corporate culture based on our values: patient focus, integrity, respect and transparency.
 
 

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