Manager, Regulatory Information Management (RIM) - IDMP

Contenido de trabajo

Site Name: UK - London - Brentford, Belgium-Wavre, Durham Blackwell Street, Poznan, UK - Hertfordshire - Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence

Posted Date: Mar 3 2023

Manager - Regulatory Information Management (RIM) - IDMP

As the IDMP RIM Manager, you will be a critical interface between the IDMP team, RP&S RIM team and enterprise IDMP data owning functions. You will be responsible for oversight of data lineage, integrity and curation activities, assessment of data flows, identifying potential risks and mitigations strategies, and optimizing business processes in conjunction with Business Process Owners. The role will support mastering of Product and Substance structured data as close to source as possible by leveraging the regulatory ISO IDMP standards. This role will help ensure the quality of structured data across systems and alignment of data with Health Authorities.

You will work collaboratively with stakeholders across R&D, GSC and Tech to agree on data 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 HA data requirements and GRA’s ability to fulfil these, as well as data governance, validation, and curation activities.

This role will include participation in both the IDMP implementation team as well as routine engagement with the RP&S RIM team.

In this role you will

• Evaluate the IDMP enterprise framework and implement RIM process revisions to ensure compliant IDMP regulatory submissions, robust data governance, and monitoring data quality
• Assess optimization and automation of any structured data submissions to health authorities to drive resource efficiencies and simplification
• Ensure continued oversight of EU SPOR data in Reg Vault with specific focus on standardized and improved addresses and Organisations (OMS) processes and maintenance of Referential (RMS) lists in conjunction with MDM CoE.
• Engage key enterprise stakeholders to ensure IDMP and other related processes are embedded as BAU for RIM team and wider use across GRA
• Operate as a Regulatory IDMP data owner, collaborating with enterprise business stakeholders to understand customer requests, competitive activities, and industry regulations/trends
• Supporting the use of SPORIFY and related software to facilitate cross functional business processes
• Partnering with Reg Systems & Services 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
• Engaging and supporting the GSK IDMP Program to enable overall business readiness and ensure preparedness for emerging structured data requirements
  
  

Closing Date for Applications: 17th March 2023 (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.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Why you?

Qualifications & Skills:

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

• Bachelor’s Degree in Life Sciences, or extensive practical experience
• 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
• Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects
• Demonstrated Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.
• Knowledge of the scaled agile framework and guiding principles
• Experience working within a complex IT system landscape with colleagues from GSK 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:

If you have the following characteristics, it would be a plus:

• 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
• 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.
• Ability to define and implement new processes and solutions with an awareness of relevant controls and impacts.
• Knowledge and experience with GSK IT applications and systems that support the Regulatory oganisation
• Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Confidence to challenge and raise requests which do not fit with the overall strategic intent of the company
• Excellent attention to detail and commitment to deliver high quality output, even under pressure.
  
  

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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.

Find out more:

Annual Report 2021

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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