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Business Introduction
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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
Lead clinical Operations and regulatory deliverables for Clinical Transparency reporting, acting as the subject matter expert and primary point of contact for processes and associated systems. This role drives process excellence, oversees external vendors, and manages KPIs, metrics, and dashboards to support risk-based decision making. You will lead cross-functional and global initiatives, own documentation and training for user readiness, support operational planning and audits/inspections, and monitor evolving global regulations for clinical deliverables to ensure GSK remains compliant and future-ready.
Key Responsibilities:
Lead and support clinical and regulatory compliance processes, ensuring adherence to applicable regulations, internal policies, quality standards, and reporting timelines.
Serve as the subject matter expert for Clinical Transparency processes, providing guidance and support to stakeholders across Clinical Operations, Regulatory, and other functional areas.
Lead and contribute to cross-functional and global initiatives that impact Clinical Transparency processes, systems, and compliance requirements.
Serve as the primary point of contact for Clinical Transparency Reporting systems and collaborate with system owners, IT, and other stakeholders to ensure effective system support, issue resolution, change management, and user adoption.
Drive process excellence through identification and implementation of process and system enhancements that improve efficiency, compliance, data quality, and readiness for evolving regulatory requirements and industry standards.
Oversee external partners and vendors supporting the processes, ensuring appropriate training, policy compliance, service delivery, and effective risk management.
Develop, monitor, and report key performance indicators (KPIs), compliance metrics, dashboards, and management reports to support risk-based decision-making and oversight.
Apply risk-based and data-driven approaches, including root cause analysis, identify improvement opportunities, strengthen frameworks, and implement mitigation plans.
Manage process-related documentation, training materials, and user readiness activities to ensure consistent adoption of processes and systems.
Support operational planning, resource forecasting, and budget management activities related to Clinical Transparency operations.
Ensure appropriate training, knowledge transfer, and ongoing support are provided to internal users and external partners supporting Clinical Transparency Reporting activities.
Support internal audits, external inspections, and compliance assessments, ensuring audit readiness and timely resolution of observations and findings.
Monitor evolving global transparency regulations, industry standards, and best practices, assessing business impact and driving implementation of required changes.
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Required Experience
Hands-on experience in Clinical Operations, Regulatory Operations, or related pharmaceutical R&D functions.
Experience developing, implementing, and improving business processes within a regulated environment.
Experience managing compliance metrics, operational dashboards, reporting tools, and performance indicators.
Demonstrated experience conducting investigations, root cause analyses, risk assessments, and implementing corrective actions.
Experience supporting audits, inspections, and compliance assessments.
Experience working with business systems supporting Clinical Operations i.e., Veeva, Clinical Development, or Regulatory processes.
Experience managing external vendors and service providers against defined service levels and quality expectations.
Ability to work effectively across global teams and diverse stakeholder groups.
Demonstrated track record of leading process improvement and change management initiatives is an advantage.
Ability to effectively manage conflicting demands in a high pressure, constantly changing environment
Experience in regulatory requirements is an advantage.
Why You?
Basic Qualification
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree
Demonstrated experience managing compliance-driven processes within a GxP-regulated environment.
Experience working with cross-functional stakeholders across Clinical, Regulatory, and Quality functions.
Experience supporting or managing regulated business processes, associated systems, and vendor relationships.
Strong analytical, problem-solving, and risk-management skills.
Excellent written, verbal, and stakeholder communication skills.
Proven ability to manage multiple priorities and deliver results in a complex, global environment.
Experience implementing digital solutions, automation initiatives, or data analytics tools to improve compliance and operational efficiency (Preferred).
Experience working within a matrix environment and influencing senior stakeholders.
What you will bring
You bring attention to detail, a collaborative mindset and a practical approach to problem solving. You communicate clearly. You look for ways to make processes simpler and more reliable. You care about integrity and public trust in clinical research.
How to apply
If this role feels like the right next step for you, we encourage you to apply. We welcome applicants from different backgrounds and experiences who share our commitment to advancing patient-centered science.
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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