Job Purpose

The Sr Manager Medical Governance for digital and technology support the Director Medical Governance for digital and technology in coordinating the reviewing and approval of digital and technology tools in accordance of the SAMD and responsible AI framework compliance processes. This role is crucial in maintaining the efficiency and effectiveness of AI governance in R&D.

This role will also support the R&D organization in navigating.

Key Responsibilities

1.       Communication and Collaboration: Act as a point of contact for internal and external stakeholders regarding AI governance and SaMD-related inquiries. Facilitate communication between the R&D AI Governance team, Business Owners, and other relevant departments. 

2.       Critically review Accountability Report submissions for completeness and work with Business/Tech Owners to update as needed in preparation for Reviews. 

3.      Review Coordination:

• Monitor incoming request and timely follow-up.
• Organize briefing material for Chair/panel review and provide a preliminary assessment of the request.
• Incorporate feedback from Chair/panel review on the Accountability Reports (ARs) and share with Business Owners for next steps.
• Schedule and coordinate Expert Panel with the right audience as well as support decision documentation (including briefing material).  Ensure timely follow-up of actions.
• Ensure appropriate meeting minutes management and document filing.

4.      Tracking and Metrics: Maintain oversight of the records of ARs and tracker, generate metrics and KPIs.

5.      Medical Governance & Standards: contribute to the development of appropriate processes, standards and tools for R&D to ensure digital tools are used safely and ethically in R&D.

6.      Training & Awareness: support the Director Medical Governance for digital and technology to develop training programs to educate internal stakeholders on the adequate governance framework surrounding the development, purchasing and compliant use of digital technologies in R&D.

7.     Issue management: support the Director Medical Governance for digital and technology in issue resolution and timely escalate issue if needed.

8.     Risk Management: Support the development of management monitoring strategy to identify and assess risks related to the deployment of digital health technologies

9.     Innovation Oversight: support consultancy questions related to new digital technologies and their medical applications.

10.     Foster communication: support development of communication to successful deployment of medical governance framework in the field.

Why You?

Basic Qualifications

• Expertise in essential regulation guidelines and GSK medical governance policies and procedures applicable to R&D.
• Broad scientific/ pharmaceutical industry background with more than 3 years of experience in digital and technology applied in pharmaceutical industry
• Good understanding of regulatory requirements related to digital and technology regulations from FDA, EMA as and other local such 21 CFR Part 820 (Quality System Regulation) for device etc.
• Relevant experience in governance type activities with understanding of the R&D, medical, commercial and compliance functions.
• Good understanding of external Codes and standards in the field
• Proven experience of managing and driving complex transversal projects involving senior management.
• Proven experience to implement change management projects.
• Ability to set and implement strategic thinking and vision
• Experience in team management, coaching and mentoring

Preferred Qualifications

• Certification / accreditation in AI/ML
• Knowledge and understanding of R&D environment, policies and procedures and applicable regulation requirements.
• Good understanding of GSK organization strategy. Able to make link within GSK organization.
• Proven sense of urgency.
• Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills.
• Excellent communication and presentations skills, ability to facilitate interfaces within various TA, medical, commercial and tech
• Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.
• Self-motivated with the ability to work independently, to develop credibility with colleagues within GSK.
• Act as a role model in line with GSK core values and behaviors.
• Comfortable to evolve in changing and challenging environment.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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.

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