Site Name: Poznan Grunwaldzka Posted Date: Feb 19 2025 Senior Manager, RIM & Data Office role purpose is to to ensure the data quality and consistent & effective use of Regulatory Information Management (RIM) systems to support GSK’s Regulatory and Pharmacovigilance obligations, GMP-compliant product supply and business efficiency across the GSK Regulatory Function. In this role, the position holder will be responsible for ensuring delivery of RIM initiatives and projects and oversight of operational teams ensuring the timely execution of RIM based requests. This may include management of a number of direct reports and leadership of global matrix teams. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Lead or project manage initiatives and projects to support evolving internal and external regulatory requirements impacting RIM processes such as Archiving, Registration Tracking, Structured data submissions i.e. EVMPD, IDMP Actively partner with Global Regulatory Operations (GRO) teams to optimise delivery and use of Regulatory Information Management systems and associated processes. Lead and motivate a team of geographically dispersed RIM Leads, enabling the curation and stewardship of Regulatory Information in accordance with defined Service Level Agreements. Drive and project manage Regulatory Information risks and issues from design to execution. This includes root cause analysis, impact assessment, action plan (including data remediation if applicable), monitoring, documentation and communication. Support the Regulatory Information Management & Data Office teams in analyzing and resolving user requests and issues Act as a key partner in using the regulatory change control procedure and governance to ensure full impact assessment and robust implementation of change. Define, implement and monitor RIM quality documentation (e.g. Procedural documentation, Training materials) to support Business Processes effectively Define, implement and monitor necessary reports to support Business Processes and GRA activities effectively. Accurately estimate scale and timing of RIM tasks. Collaborate with the Regulatory Information Management & Data Office team to plan and resource effectively and ensure timely and complete delivery. Define, ensure development, monitor, and oversee the necessary metrics to evaluate and improve RIM performances in line with GRA and RIM priorities. Lead operational matrix teams across the broader Regulatory Information Management & Data Office and Global Regulatory Operations group, globally Identify opportunities to drive efficiency within Regulatory Information Management & Data Office and GRA via continuous improvement programs, influencing software vendors and identifying innovation solutions. Where applicable, perform the role of RIM Subject Matter Expert, driving a partnership with GRA Process Leads, developing deep understanding of GRA E2E business process, sharing technical expertise to support the business and continuous improvement. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s Degree ( Scientific or technical ) Extensive experience of Regulatory Affairs covering a breadth of global regulatory procedures Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers Experience working within a complex IT System Landscape within a regulated environment People Management Experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong sense of urgency, Ability to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way. Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts. Knowledge and experience with GSK IT applications and systems that support Regulatory Information Management (RIM) Demonstrated ability to think flexibly to meet constantly shifting priorities and timelines. Excellent attention to detail and commitment to deliver high quality output, even under pressures. Why GSK? we offer a wide range of additional benefits: Career at one of the leading global healthcare companies Hybrid work ( 2/3 days per week from the office) Contract of employment Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit, company car) Life insurance and pension plan Private medical package with additional preventive healthcare services for employees and their eligible counterparts Sports cards (Multisport) Possibilities of development within the role and company’s structure Personalized learning approach (internal training, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, 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 #LI-GSK #LI-HYBRID #LI-DEI 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. 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. 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