Data Manager, Regulatory Data Office (Rdo)

Site Name: UK - London

• New Oxford Street, Durham Blackwell Street, Poznan Grunwaldzka, USA - Pennsylvania

• Upper Providence

Posted Date: Jun 20 2024

As the Data Manager, Regulatory Data Office (RDO) you will be responsible for design, implementation and oversight of processes which assure the high quality of GSK's regulatory data as well as assessment of enterprise data flows, data governance, identifying potential risks and mitigations strategies. You will be involved in process and system design and improvement, with a particular focus on building quality and efficiency into our Regulatory data management processes. The role will support mastering of critical structured data (ie., Product and Substance) as close to source as possible by leveraging regulatory standards (ie., ISO IDMP) and will help ensure the secure and efficient interoperability of Regulatory data across the GSK business enterprise via the Development Data Fabric (DDF).

The Data manager will work collaboratively with stakeholders across R&D, Global Supply Chain (GSC), and Tech to agree on data standards, quality and governance priorities and look to maximise the business value and build plans to deliver against those priorities. This role will assist with the assessment of Health Authority data requirements and GRA's ability to fulfil these, as well as data governance, validation, and curation activities.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will

• Evaluate the enterprise data framework and implement Regulatory process revisions to ensure compliant regulatory data submissions (XEVMPD, IDMP, eAF), robust data governance, interoperability and monitoring of data quality

• Assess optimization and automation of any structured data submissions to health authorities to drive resource efficiencies and simplification

• Actively partner with RIM Data Quality and Remediation functions to ensure optimal governance and quality of regulatory data via delivery, implementation and oversight of in-process controls and management monitoring supporting Regulatory Vault.

• Ensure continued oversight of Health Authority data (ie., EU SPOR) in Reg Vault with specific focus on standardized and improved processes and maintenance of interoperable data in conjunction with stakeholders (RIM, MDM, MDS, GSC, etc).

• Operate as a Regulatory data owner, collaborating with enterprise business stakeholders to understand customer requests, competitive activities, and industry regulations/trends; ensure evolving data standards and other related processes are embedded as BAU for RIM team and wider use across GRA

• Partner with Regulatory Systems & Innovation and Regulatory Tech to support the continued iteration of the data model within Regulatory Vault. Supporting the movement of data from GSK configuration to Veeva configuration as product matures

Why you?

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in Life Sciences

• Extensive experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures

• Demonstrated ability to work with regulatory product data to drive compliance and business process improvements related to RIM

• Demonstrated Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.

• Experience working within a complex IT system landscape with colleagues from Tech, Quality and Training organisations to deliver GXP compliant systems

• Ability to manage and motivate matrix teams in a globally diverse organisation

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Knowledge of ISO IDMP (Identification of Medicinal Products) standards, Master Data Management (MDM) principles, xEVMPD requirements and/or data governance practices

• Knowledge of the use of data in regulatory processes and systems; experience in Regulatory Information Management (RIM) systems such as Veeva Vault

• Agile and/ or Veeva RIM experience is advantageous

• Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects

• Service/customer-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.

• Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.

Closing Date for Applications

• 04 July 2024 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. 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.

Find out more:

Our approach to R&D.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive

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