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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
You will lead medical writing activities that support clinical development and regulatory submissions. You will work closely with clinical pharmacology, non-clinical, pre-clinical research, regulatory and biostatistics external partners to plan, author and deliver complex documents. We value clear scientific judgement, practical project leadership and collaborative communication. This role offers you with meaningful impact and alignment with our mission of uniting science, technology and talent to get ahead of disease together.
This role will provide you with the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
Lead planning, authoring and quality control of early phase clinical and regulatory documents.
Coordinate cross-functional and external input to ensure alignment and regulatory readiness.
Serve as lead author on complex submissions and contribute to submission strategy.
Mentor and coach medical writers and develop training materials for the team.
Identify and implement process improvements to increase quality and efficiency.
Apply digital tools and technology
Responsibilities
Author and review documents including but not limited to Clinical Pharmacology Sections for Regulatory Submissions. Lead the authoring and development of Module 2.7.1 (Summary of Biopharmaceutics) and Module 2.7.2 (Summary of Clinical Pharmacology Studies), clinical study reports, protocols and submission modules and briefing documents.
Maintain document trackers and flag risks early to keep projects on schedule.
Ensure documents meet regulatory requirements and internal quality standards.
Operate in a matrix-team and build strong working relationships with internal stakeholders and external authors.
Provide clear, constructive feedback and support continuous learning in the team.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Minimum 10+ years of experience including in early phase medical writing
Strong project management skills and ability to deliver multiple documents on tight timelines.
Excellent written and verbal communication skills with attention to scientific detail.
Experience working in a global, matrixed environment and managing external vendors.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Advanced degree such as MSc, PhD, PharmD in pharmacology.
Experience leading complex submissions, preferably authoring modules 2.7.1 and 2.7.2.
Familiarity with medical writing and submission tracking tools.
Experience mentoring writers and leading cross-functional teams.
Record of driving process improvements or introducing automation in writing workflows.
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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