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About the Role

ViiV Healthcare is seeking a Principal Medical Writer to lead and deliver high-quality medical writing for complex clinical and regulatory projects. This role involves working closely with clinical, regulatory, statistical, and cross-functional teams, emphasizing scientific rigor, clear communication, collaboration, and ownership. The position offers visible impact, professional growth, and meaningful work aligned with GSK's mission.

Responsibilities

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.

Requirements

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.
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.

Skills

Clinical Development
Clinical Trial Designs
Communication
Customer Service
Decision Making
Emotional Intelligence
Influencing Without Authority
Learning Agility
Literature Reviews
Medical Writing
Pharmaceutical Industry
Presentation Techniques
Regulatory Submissions
Scientific Writing
Strategic Thinking

Experience Level

5+ years of experience in medical or regulatory writing
3+ years of experience with regulatory dossier development
3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents

Education Level

Bachelor's degree in life sciences, health sciences, or a scientific field.
Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.

Benefits

Comprehensive benefits program

About the Company

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 its 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.
Our work culture is fast-paced, diverse, inclusive, competitive, and caring.
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.
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.

Equal Opportunity

GSK is an Equal Opportunity Employer.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.