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
You will lead document anonymisation activities that support ethical and transparent sharing of clinical research data. You will work closely with cross-functional teams and external partners to prepare, anonymise, review and deliver clinical documents on time. We value curiosity, technical care, collaboration and a growth mindset. This role offers clear career development, meaningful impact on public trust in research, and alignment with GSK’s mission of uniting science, technology and talent to get ahead of disease together.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Work closely with senior clinical data transparency leadership to align processes in line with regulations.
Serve as a subject matter expert on regulatory requirements for document anonymization, including relevant agency policies and national guidance.
Manage business relationships with external vendors to ensure quality, on time delivery and in line with organizational expectations.
Manage daily operations of anonymizing clinical documents including regulatory requirements like EMA Policy 0070 and Health Canada PRCI ensuring quality and timelines targets are met
Take overall accountability for the document anonymization capability, driving development, competence, and strategy internally and externally.
Maintain strong relationships with internal business partners and act as a key contact supporting relevant functions for both current and historical studies.
Create and lead a community of practice to improve cross‑communication between central functions, medical policy, and statistics/programming groups. Contribute to industry and regulatory standards for data re‑use and anonymization.
Serve as the Business Capability Lead/Subject Matter Expert for document anonymization capabilities, including systems/technology and readiness for regulatory inspection/internal audit. Proactively propose process improvements based on feedback from clinical groups and governance bodies. Engage with teams authoring clinical documents to recommend working practices that minimize personally identifying information (PII) and commercially confidential information (CCI) in source documents.
Ensure proper documentation and oversight of all business processes, standard procedures, and work instructions related to document anonymization, ensuring compliance with regulatory requirements.
Monitor new technologies and external trends to ensure the capability leverages best‑in‑class approaches.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Master’s degree in life sciences, pharmacy, clinical research, or a related field.
At least 6 - 9 years’ experience in document anonymisation, clinical trial transparency, or related regulatory work.
Experience in Pharmaceutical company environment and specifically in matrix organization
Experience in managing clinical trial (study, data, or system/technology) activities.
Good understanding of clinical trial lifecycle, clinical trial metadata [i.e. information about the trials], clinical trial data [i.e. observed data collected as part of the trial], clinical documents.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Good understanding of R&D and the clinical development process to enable understanding of anonymization related activities, manage risks and, where required, develop novel solutions and processes.
Good overview and understanding of end to end study process and data flow; in-depth knowledge of patient data – a recognized expert.
Ability to bridge the communications gap between scientific/medical and non-scientific organizations.
Ability to communicate the importance of relevant technical or process solutions to business problems. Provide personalized communications with reasons and rationale, context and relevance of the thinking. Describe anonymization in a way that can be understood by the Business.
Excellent verbal and written communication skills.
Ability to work with a high degree of independence.
Good teamwork and interpersonal skills with demonstrated ability to interact effectively across boundaries with other global functions using influencing and relationship building skills.
Ability to effectively manage conflicting demands in a high pressure, constantly changing environment and still achieve timely delivery
Awareness of medical writing, publishing and regulatory processes and associated deliverables.
Experience of reviewing clinical documents is an advantage.
What success looks like
You deliver anonymised documents consistently and on time. You build strong working relationships with internal teams and vendors. You help improve anonymisation processes and support a culture of quality and transparency. You welcome feedback and use it to grow.
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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