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 form 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 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 pl.recruitment-adjustments@gsk.com to discuss your needs. #LI-GSK #LI-HYBRID #LI-DEI Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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. 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