Senior Principal Medical Writing, Associate Director

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.

 

The Senior Principal Medical Writer, Associate Director 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.

 

This role is hybrid, with a mix of on-site collaboration and remote focused work. Specific on-site days will align with team arrangements in the United States.

Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Serve as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
• 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.
• Review and contribute to early statistical outputs and other process-related activities in support of medical writing deliverables.
• Mentor and coach junior writers, providing feedback, training, and practical guidance to build team capability.
• Drive transformative authoring and review principles, participate in digital technology initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.
• Participate in periodic reviews and updates of governance documents and processes , providing input on improvements to processes, roles, and controls to enhance quality, efficiency, and compliance in medical writing
• Provide structured support to the Clinical Submission Lead by driving the development and operationalization of the clinical submission strategy (roadmap, workplan, process steps) and offering direction, guidance, and mentoring to medical writers, including review and feedback on their work products

Why You?
Basic Qualification:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Master’s or PharmD, MD, or PhD in life sciences, clinical research, pharmacy, medicine, or related field, or equivalent experience.
• 5+ years of medical or regulatory writing experience in pharmaceutical, biotech, or CRO settings.
• Experience in authoring clinical protocols, clinical study reports, and regulatory dossier development, Common Technical Document (CTD) module documents
• Experience in clinical trial design, statistical interpretation, and regulatory requirements (including ICH and Good Clinical Practice).
• Experience in managing multi-stakeholder projects and deliver on time within a matrix environment.

Preferred Qualification:
If you have the following characteristics, it would be a plus

• PhD, PharmD, MD, or equivalent advanced scientific qualification.
• Familiarity with clinical document systems and publishing platforms (for example, Veeva Vault).
• Experience using automation tools, templates, or review tools to improve writing efficiency.
• Prior exposure to cross-regional or global submissions and interacting with regulatory authorities.
• Excellent written and verbal English communication skills with strong attention to detail.
• Experience leading or coordinating writing teams and mentoring junior staff.

 

#LI-ViiV

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

 

 

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.

Why Us?

At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 40 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. 

We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.

Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities.

Having a truly inclusive culture where we’re all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [email protected]

ViiV 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.

Important notice to Employment businesses/ Agencies

ViiV 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 ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. 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 ViiV. ViiV 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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/