ViiV Healthcare (GSK) Associate Director, Scientific and Medical Writing

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 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 and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in 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 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 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 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, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. The Associate Director, Scientific and Medical Writing is responsible for leading HIV-focused regulatory writing activities (NDAs, MAAs, supplements, and related submissions) and for managing program-level writing efforts when appropriate. This role partners with clinical and regulatory teams to ensure deliverables align with the clinical strategy, meet business objectives, and satisfy regulatory timelines; it may also oversee projects that span multiple products.

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

• Provides key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents including, but not limited to, protocols, clinical study reports, common technical document summaries and Clinical Overview, briefing documents for regulatory authorities, responses to regulatory authority questions, investigator brochures and annual reports.
• Leads matrix teams in planning and production of multiple clinical documents to support regulatory submissions worldwide, working with CROs and/or independent contractors as needed.
• Ensures global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary.
• Plans and successfully implements large submissions independently, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary.
• Provides guidance and facilitation to submission teams in development of detailed submission plan.
• Effectively organizes content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
• Acts as lead author on submissions.
• Actively contributes to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams.
• Has ability to prioritise effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.

Basic Qualifications

• PhD or PharmD or MPH or MS
• Lead-author experience on regulatory submissions (documents including, but not limited to, clinical study reports, common technical document summaries and Clinical Overview, and briefing documents)
• Infectious disease experience
• Matrix leadership experience

Preferred Qualifications

• Scientific and operational experience to identify and analyze problems and information of considerable complexity and implements effective plans and solutions.
• Experience with quality decision making and creative problem resolution that impacts program/project direction.
• Strong oral and written communication skills.

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 usrecruitment.adjustments@gsk.com. 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 law.