We are uniting science, technology and talent to get ahead of disease together.
Our community guidelines: https://gsk.to/socialmedia

translator

• Utilize deep expertise in statistical genetics
• Provide strategic leadership and hands-on analytical prowess
• Work within and lead cross-functional GSK project teams
• Identify, set up and oversee external scientific collaborations
• Communicate analysis findings, with expert interpretation
• Stay informed about emerging technologies
• Lead a team of direct reports

Director – Translational and Clinical Genetics

Director in the Translational & Clinical Genetics team at GSK, providing strategic leadership and expertise in genetics for drug development.

director

• Lead the design and analysis of non-interventional studies, aligning with cross functional teams, managing timelines, and ensuring methodological rigor and quality control.
• Apply statistical and RWD expertise to guide the selection and appropriate use of complex health data sets, co-develop variable definitions, code lists, and author technical specification documents.
• Develop and refine statistical analysis plans, conduct complex statistical analyses, including for example causal inference, comparative effectiveness, target trial emulation, and communicate findings to internal and external stakeholders.
• Serve as a senior-level RWB consultant within matrix teams, leveraging in-depth expertise on assigned assets.
• Serve on enterprise level strategic initiatives, for example Disease Area Acceleration Teams, for organizational deliverables.
• Present statistical analyses and insights effectively to internal stakeholders and external audiences, including conferences and publications, showcasing the value of biostatistical contributions.
• Engage in strategic communication to reinforce the role of biostatistics in driving innovation and decision-making across the organization.
• Stay informed on emerging industry trends and incorporate cutting-edge biostatistical methods to improve study designs and analytics.
• Provide biostatistical expertise on RWD during regulatory submissions, preparing for meetings and addressing regulatory queries to ensure compliance with industry standards.

Associate Director, Principal Statistician – Real-World Biostatistics

Associate Director/Principal Statistician driving strategic biostatistical initiatives in real-world evidence. Collaborating across teams to enhance decision-making for regulatory submissions and trial design.

content-marketing-manager

• Drive operational excellence and ensure high-quality content approval processes
• Oversee key training and capability initiatives
• Manage vendor relationships and ensure compliance monitoring
• Lead process improvements and performance metrics

Senior Director, Medical Information, Quality, Training and Operations

Senior Director overseeing Medical Information and Content Approval at GSK. Leading operational excellence and ensuring compliance in content approval processes across the organization.

• Act as a Diagnostics (Dx) leader to deliver on the vision of equipping GSK to be a leader in precision medicine through Dx development driving value by identifying the right patient for the right medicine
• Lead, manage, and develop a Dx team comprised of senior talent
• Participate in leadership meetings to create cross-functional Precision Medicine strategies.
• Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine areas.
• Define the Dx strategy from an asset perspective to support global drug registration
• Lead the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
• Be accountable for all aspects of Dx development with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
• Oversee all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
• Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
• Must be able to manage multiple projects and workstreams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives
• Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
• Ensure learnings and best practices are shared across R&D
• Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders
• Work with regulatory, policy, BD, TAs and business unit colleagues and key leadership within project teams
• Work with project leads to ensure efficient implementation of all key deliverables

Executive Director, Diagnostics

Diagnostics Leader at GSK focusing on precise medicine innovations through diagnostics development. Overseeing global drug registration and collaboration across therapeutic areas with a team of senior talent.

compliance

• Manage and maintain regulatory information within RIM systems, ensuring accuracy and timeliness for supporting GRA submission activities and responding to urgent, time-sensitive requests.
• Act as a subject matter expert for RIM systems and processes, requiring a deep understanding of Regulatory Vault data model and legacy RIM systems, share technical expertise with stakeholders, mentor junior colleagues, and collaborate with GRA Process Leads to support business needs and improvements.
• Monitor and ensure data quality, perform root cause and trend analysis, and implement corrective/preventative actions while ensuring compliance with data standards, procedures, and system reference data maintenance.
• Support system validation activities, such as User Acceptance Testing, and contribute to change control processes, including assessing the impact of system or process changes.
• Perform routine and ad-hoc data extraction and transformation from RIM systems for KPIs in the context of data quality improvement and performance monitoring
• Establish and maintain appropriate procedural documentation where needed: SOP, WI, HtG, Why You?

Senior Regulatory Specialist – Regulatory Information Management

Senior Regulatory Specialist managing regulatory information and support for GSK's product portfolio. Collaborating across teams to ensure compliance and quality in regulatory data management.

• Managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products including response to questions from Agency;
• Define and agree regulatory strategy, complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;
• Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
• Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements;
• Effective communication also in a digital context, including virtual meetings and digital platforms;
• Act as subject matter expert in regulatory processes;
• Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems;
• Supporting digital transformation through active participation in building digital skills;

Senior Regulatory Specialist, New Registration CMC, CMC Excellence

Senior Regulatory Specialist managing CMC new files and CTA assignments for Pharma and Vaccines products. Working with colleagues in Global Manufacturing & Supply to ensure regulatory compliance.

auditor

• Independently plan, lead, and conduct routine and complex Quality Assurance audits of GSK studies, systems, processes, and external vendors to assess compliance with GCP, GSK policies, and applicable local regulations
• Document objective and process-oriented audit findings in an audit report and ensure robust CAPAs to address findings and their root causes in a timely manner
• Report and present findings from audits to relevant stakeholders and provide advice on compliance, quality improvement, and risk assessments
• Support regulatory inspections related to GSK
• Maintain up-to-date and in-depth knowledge of national and international GCP legislation, guidelines, and relevant GSK processes and procedures
• Build and maintain beneficial working relationships with other quality and compliance groups and relevant internal/external customers

GCP Quality Auditor – m/f/d

GCP Quality Auditor performing audits to ensure compliance with GSK policies and Good Clinical Practices. Responsibilities include documenting findings, maintaining knowledge of GCP legislation, and supporting regulatory inspections.

We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia

GSK

About the company

Open jobs

103 jobs found