Site Name: USA - Pennsylvania - King of Prussia
Posted Date: May

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

As part of the R&D Records Management and Archiving (RMA) team, this position will:

• Ensure that the R&D Archives are inspection ready at all times to ensure that country regulatory agency inspections, e.g., FDA, MHRA, etc., proceed smoothly and without incident
• Ensure that all regulatory agency requests of the business to produce archived materials are met within current SLAs.
• Ensure physical and electronic archives are managed and operated in compliance with GSK policies, SOPs, standards and external regulations, partnering with R&D, IT and infrastructure groups
• Ensure that R&D physical and electronic proprietary information records are protected and preserved in accordance with specific government regulatory requirements and company policies, for up to 65 years, e.g., GxP regulations, GSK Global Records Retention
• Ensure delivery of the archive service (including processing and retrieval of records) to R&D and Legal, meeting legal, regulatory and business requirements

Key Responsibilities:

• Provide direction to outsourced operations staff and other third party suppliers regarding scheduling and prioritization of work assignments
• Represent GSK R&D as the named GLP or GCP Archivist during internal audits and external inspections, including resolving findings
• Partner with the R&D business and business IT groups who support them to enhance the management and archiving of proprietary information to maintain long term protection and minimise risk to GSK
• Facilitate new and improved electronic archiving processes and promote good records management practice
• Develop and maintain a thorough knowledge of R&D business processes and objectives through effective working relationships with relevant R&D business groups
• Contribute to the overall strategy and objectives of the RMA organisation, and the development of proprietary information management policies, standards and best practices

Basic Qualifications:

• Bachelor's degree in related field
• Three or more years of experience in records management or archiving

Preferred Qualifications:

• Awareness of new developments in archiving and relevant regulations
• Familiarity with AI/ML technologies used in drug discovery and development
• Extensive experience and application of in depth knowledge of electronic proprietary records, archiving or information management
• Experience in the pharmaceutical industry, particularly a good working knowledge of relevant regulations (e.g. GxP, ICH) as they apply to archiving
• Understanding of R&D business processes and requirements, especially relating to Discovery, PreClinical and Clinical records generation and management and feeds them into RMA service, product or process strategy
• Good knowledge of the GSK organizational structure, general awareness of GSK's major disease franchises and a good understanding of the GSK R&D process and of information generation within GSK
• Well-developed analytical and problem solving skills

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

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