Junior Submissions Delivery Specialist - Publishing Team
GSK
Poznan Grunwaldzka, , Poland,
5 d. temu

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 Junior 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.

As our team is growing, we are currently looking for several candidates.

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) available to work full-time hours
  • 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
  • We offer :

  • Stable and interesting job in one of the leading global healthcare companies.
  • Access to newest technologies and solutions.
  • 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.
  • LI-GSK
  • 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 / 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.

    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.

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