Mature Marketed Products, Medical/ Scientific Associate Manager

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 an experienced scientific professional in Mature Marketed Products for the position of Associate Scientific Manager. The ability to thrive in a highly technical and scientific environment and work with multiple global internal stakeholders within both ViiV and GSK including medical, regulator and safety scientists will be essential to delivering success in this role. Cross-functional partnering and the ability to remain highly adaptable will be critical. It is expected that the successful candidate will have demonstrated critical thinking and technical writing skills as well as have experience in product lifecycle maintenance activities. Demonstration of the ability to develop strong internal and external networks is also important.  Successful outcomes will include reviewing and authoring precise technical documents for license maintenance and other lifecycle activities associated with Mature Marketed Products.  These activities are important in maintaining access to HIV treatments globally which aligns directly to ViiV Healthcare’s mission of leaving no person with HIV behind.

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

Deliver Results Through Exceptional Scientific Writing, Reviewing and Relationships

• Contribute to the delivery of relevant license maintenance activity and other lifecycle activities for Mature Marketed Products (MMP), liaising with R&D technical experts (e.g. GRA, GCSP) as appropriate under the direction of the Global Medical Leader
• Assist in delivering the evidence needs for the relevant MMP assets in partnership with LOCs, R&D colleagues and other stakeholders
• Serving as a clinical designate to meet ViiV Healthcare annual and periodic regulatory and safety reporting requirements for the New Drug Application (NDA) Annual Reports and  Drug Safety Update Reports (DSURs) for multiple MMP assets
• -Supporting the MMP Team in reviewing responses requesting supplementary information (RSI) by Health Authorities (HA) and assisting in locating supporting documentation
• Depending upon task complexity, either assisting the Clinical Director or Clinical Manager in the generation of targeted clinical overviews, clinical study reports, Type 2 variations, clinical Modules to support product registration or product renewals or other required documents supporting updates to the Global Datasheets and/or performing quality reviews of these and other supportive documents or publications as necessary
• May act as deputy for more MMP senior colleagues as required

Compliance, Accountabilities, and Values Based Culture

• Act in ways consistent with ViiV Healthcare’s culture, expectations, and values
• Be an agent of change by embracing the ambiguity in a global environment and seeing setbacks as opportunities to learn and grow
• Escalate issues and risks when needed; display courage by ‘speaking up’
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