This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
Translate complex clinical and statistical data into clear, accurate, and well-structured scientific narratives for diverse audiences.
Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.
Why You:
Requirements
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor's degree in life sciences, health sciences, or a scientific field.
5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents.
If you have the following characteristics, it would be a plus:
Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.
Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
Familiarity with statistical concepts and ability to interpret clinical data.
Strong problem-solving skills and ability to adapt to changing priorities.
Experience working in multicultural or remote team settings.
Proven ability to independently write and manage complex regulatory documents.
Strong understanding of International Council for Harmonization (ICH) guidelines and Good Clinical Practice (GCP).
Excellent written and verbal communication skills, with attention to detail.
Experience managing multiple projects and meeting deadlines in a fast-paced environment
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
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 su
Benefits
Health insuranceRemote work options
Additional Information
ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic.
We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference.
While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities.
ViiV Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical, and cross-functional teams. We value scientific rigor, clear communication, collaboration, and ownership. This role offers visible impact, professional growth, and meaningful work that aligns with GSK's mission of uniting science, technology and talent to get ahead of disease together.
Gsk · Durham Blackwell Street