Oferta pracy

Clinical Documentation Manager

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired 23 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular), senior specialist (Senior)

Your responsibilities

  • Ensure a sustainable model is in place to build capability in the organization and drive excellence in the creation and delivery of a TMF that meets regulatory needs for every clinical trial conducted in GSK.

  • Support the embedding and implementation of eTMF and associated systems across Pharma R&D by working directly with Study Teams as they use the eTMF system to ensure inspection readiness throughout the study lifecycle.

  • A subject matter expert and member of a TMF Inspection Readiness Support team that guides study teams preparing for regulatory inspections.

  • Work with the business to improve our understanding of the challenges and associated solutions to ensure excellence in inspection readiness on a day-to-day basis.

  • Drive continuous improvement of specific processes/projects/systems/programs/policies within clinical information management using change management methodology.

  • Build consensus through effective communications with relevant customer groups and project teams to ensure an integrated, comprehensive, enterprise solution continues to be implemented.

Our requirements

  • Bachelor’s degree in a scientific discipline.

  • Knowledge of clinical documentation management technologies (e.g., data warehousing, Documentum, SharePoint), approaches (e.g., master data management) and techniques for managing information quality (e.g., data profiling).

  • Knowledge and experience with the use of TMF systems and associated business processes.

  • Proven track record of managing and delivering large-scale, complex projects, particularly related to the design, management and implementation of global processes and technologies.

  • Ability to provide effective consultation and training.

  • Ability to analyze business problems/opportunities.

  • Superior interpersonal skills, including the ability to establish and maintain good working relationships with peers, colleagues and management.

  • Excellent written and oral communication.

What we offer

  • Career at one of the leading global healthcare companies.

  • Contract of employment.

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).

  • Life insurance and pension plan.

  • Private medical package with additional preventive healthcare services for employees and their eligible.

  • Sports cards (Multisport).

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

  • Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training).

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).

  • Supportive community and integration events.

  • Modern office with creative rooms, fresh fruits every day.

  • Free car and bike parking, locker rooms and showers.

  • 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

At GSK, we’re constantly developing new products and improving our established medicines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring these products are correctly prescribed and used is essential, and that’s where our Labelling team is key. The Regulatory 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 Product Information (Labelling), which contains information for prescribers and patients.

Respond to a challenge and take a lead in a diverse international regulatory environment. In this role you have an opportunity to make a positive impact on GSK Patients worldwide delivering Labelling documents and data created by you and your Team.

The Country Labelling & Business Performance Manager is accountable for leading and managing the team responsible for delivering local labelling submissions and management of global labelling documents in line with existing business needs, strategies, goals and objectives in order to support GSK’s product licenses worldwide. Country Labelling & Business Performance Manager cooperates with colleagues in clinical, safety and other regulatory functions according to agreed ways of working, priorities and deadlines to ensure delivery of overall Departmental goals.

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