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Submissions Delivery Specialist - Regulatory Publishing

GSK

  • Poznań

    Poznań, Greater Poland
  • offer expired a month ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • remote recruitment

Your 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

Our requirements

  • Bachelor’s or Master's degree in scientific or technical field

  • Previous experience (in regulatory affairs, pharmaceutical industry, life sciences research)

  • 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 matrix organization

  • If you are meeting most but not all basic requirements, we may consider hiring you as Junior Submissions Delivery Specialist.

Optional

  • Work experience with tools (e.g. Adobe Acrobat, SharePoint, Documentum, RIMS, Citrix, Remote desktop, eCTD Xpress, Publisher, Lorenz, eSubmission Gateway – FDA Web Trader, EMA Gateway CESP)

  • Experience in document management

  • Experience in fields related to regulatory affairs

  • Experience in publishing electronic submissions for a Regulatory Authority

What we offer

  • Remote work (during pandemic)

  • Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs)

  • Stable and interesting job in one of the leading global healthcare companies.

  • Access to newest technologies and solutions.

  • Friendly work environment and great atmosphere in our teams.

  • Possibilities of development within the role and company’s structure.

  • 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.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

GSK is in the midst of an exciting period of investment and growth in its new European financial centre, located in Poznan and Warsaw, with almost 300 new employees joining to date.

The European financial centre is responsible for providing a wide range of business services to the European region, as part of a wider network of regional hubs around the globe. These centres of expertise work together as a One Finance team to support GSK’s global operating model by delivering best in class services, sharing best practice and knowledge and working closely with other markets and colleagues, supported by our global headquarters in London.

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Submissions Delivery Specialist - Regulatory Publishing

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

Submissions Delivery Specialist - Regulatory Publishing 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.