Informacje o stanowisku

Site Name: Warsaw, Poznan Pastelowa

Posted Date: Jan 22 2025

Specialist Clinical eSubmission & Technical Compliance

Job Purpose:

• To perform technical quality checks and ensure procedural compliance as per electronic submission requirements and internal SOPs, standards and execute publishing, uploading to EDMS (Veeva), cross linking between vaults for clinical/regulatory documents authored by global clinical delivery team.

• Perform technical compliance checks on clinical and submission documents and produce high quality submission ready documents.

• Perform submission crosslinking between vaults for submissions based on GRA requirements.

Key Responsibilities:

• Independently perform the following:

• Compliance checks, publishing, and finalizing a variety of clinical and regulatory documents (e.g., CSR, IB, clinical overviews and summaries) as per the checklist, SOP and HTG. Ensure finalized/published documents are submission-ready and comply with GCP, HRA, GSK and other applicable international standards. Prepare electronic compilations in accordance with the functional and regulatory requirements on submissions – hyperlinks, bookmarks, pagination, TOCs, validation, eCTD – using appropriate prequalified systems/applications.

• Plan and execute collection and compilation of appendices in collaboration with internal stakeholders’ as per GCP and GSK standards.

• Coordinate and communicate to ensure eTMF compliance and inspection readiness of clinical regulatory documents.

• Support the team towards overall implementation of functional trackers, KPIs, and management monitoring.

Academic and Technical Qualification:

• Academic qualification: Bachelor’s Degree/Master’s Degree in Science (Pharmacy, Life Science).

• Technical Knowledge: MS Word, PDF, Veeva, ISITool Box.

Experience:

• 4-7 Years of experience in the clinical publishing domain and experience with preparing clinical submission documents in submission-ready format (i.e., Word Formatting; PDF creation, bookmarking, hyperlinking, page orientation etc.)

Why GSK?

• 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).

• Hybrid working model (where GSK site are in Poland).

• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working from the office, short Fridays option, health & well-being activities).

• Life insurance and pension plan.

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

• Sports cards (Multisport).

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

• Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training).

• Supportive community and integration events.

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

Inclusion & Diversity at GSK:

As an employer committed to Diversity and Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at to discuss your needs.

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