ViiV Healthcare (GSK) Scientific and Medical Writing Manager

GSK•Durham, NC

About The Position

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 Scientific and Medical Writing Manager 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.

Requirements

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

Nice To Haves

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

Responsibilities

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. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.
Plans and successfully implements large submissions independently, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary. Recommends solutions for problems that affect timelines. Provides guidance and facilitation to submission teams in development of detailed submission plan.
Ideally demonstrates an understanding of the interdependences of various contributing functions and manages problems affecting timelines as necessary. Ideally demonstrates an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
Proposes resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
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. Ideally, proactively identifies medical writing training needs for staff and develops/implements training sessions.
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.