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 Biopharmaceutics, Clinical Pharmacology, Clinical Study Protocols, Clinical Study Reports, Coaching, Early Phase Clinical Trials, Medical Writing, Pharmacodynamics, Pharmacokinetics, Regulatory Compliance 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in “gsk.com”, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine. We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.