Site Name: USA - North Carolina - Durham Posted Date: Jun 5 2024 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 Director, NA Medical Governance, Monitoring, & Quality Assurances' primary function of this role is to anticipate and mitigate risk for Medical Affairs now and into the future. This role will maintain a robust governance framework through the management of evolving policies and comprehensive risk mitigation plans, including medical governance, monitoring, and quality assurance areas. This includes being accountable for risk monitoring, quality documentation & reporting, and audit administration for North American Medical Affairs. The Director, NA Medical Governance, Monitoring, & Quality Assurance will report to the Head, US Medical and Strategic Operations and will partner closely with key internal stakeholders including the Medical Field, Central Brand and Capabilities Teams, Legal, Regulatory and Compliance to design, implement, and execute risk management strategies to ensure adherence to quality and compliance for the Medical Affairs Team. The Director will be based out of ViiV's US Headquarters in Durham, NC (Chapel Hill/Raleigh/Cary/Wake Forest area) and is eligible for a domestic relocation package. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Collaborate/Partner with Global Medical Governance, US Legal and Compliance, and NA Med Affairs leadership to align on and develop control and guidance documents to stay updated on federal and state regulations associated with VH Medical Affairs Practices. Oversee the risk management of ViiV Medical Affairs Practices (could include future pipeline products). Deliverables to include analyzing trends from monitoring reports, risk assessment mapping, risk mitigation strategy plans and impact planning and review. Create, develop, evolve and maintain NA/US specific policies and standard operating procedures to meet the changing needs of the organization. These will outline quality and compliance monitoring requirements, metrics, and reporting frequency. Guide and serve as resource for the ViiV Medical Affairs team with internal and external audits including developing and executing corrective action plans from monitoring and audit reports Build communication strategies and manage implementation related to performance, audit findings/output and activities for VH Medical Affairs team including Medical Affairs updates and trainings related to global code changes and US regulatory changes including creating training materials to impart knowledge and understanding to drive adherence to NA policies and SOPs Revise and maintain document control protocols to ensure formal repository, tracking, and updating of all program governance materials, including Standard Operating Procedures, Business Rules, Training Documents, etc. Drive development and embed controls within Medical Affairs Monitor medical affairs activities and ensure compliance with governance principles including, recommending needed changes; Implement and oversee monitoring requirements related to evaluating medical responses to healthcare providers (HCPs) inquiries; lead and provide oversight to critical processes and programs for US Medical Affairs; Evaluate, drive and refine continuous quality improvement to processes and programs for Medical Affairs; Educate and provide guidance on policies/regulations to all levels of MA Serve as Medical Governance point of contact for Global and US Governance Teams Serve as the Point of Accountability for US MA with Compliance & Audit Teams Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/BA degree & 5 plus years of leadership experience in a matrix environment and organize, coordinate & prioritize key deliverables 5 plus years of experience in Medical Affairs/R&D/Medical Services or other pharmaceutical or healthcare setting with scientific background & medical knowledge 3 plus years working in performance improvement/quality management/program audit and monitoring. 3 plus years of experience working with key internal stakeholders, including legal, market access, privacy, and compliance. Experience with mitigating risk and have led issue identification, resolution and change management Experience providing solutions and guidance to medical leadership Experience in interacting with all levels of the organization, including senior-level business partners / leaders. Ability to travel approximately 10% of the time. Preferred Qualifications: If you have the following characteristics, it would be a plus: In-depth knowledge of the ViiV Governance Framework in order to access, interpret and apply policies and standards for Medical Services roles. Experience developing strategic plans of action Experience developing and implementing compliance & risk management framework Audit and Compliance Experience including managing audit findings (i.e., CAPAs) Ability to influence across the internal matrix to drive change and gain stakeholder alignment. Consistently delivers on project requirements and strives for flawless execution. Ability to successfully align all levels of the organization through influence. Learning through experience – Demonstrates curiosity and learns from the experience of success and failure; proactively communicate knowledge with others to affect continuous improvement. Ability to manage multiple priorities with excellent organizational and problem-solving skills. Strong speaking, writing, and presentation skills. Ability to present to groups of all sizes, sometimes at short notice. Demonstrated exceptional judgment and strong analytical abilities based on knowledge, previous experiences to bring out new insights gained from others or from analysis. Strong values-based decision making required #LI-ViiV #LI-GSK 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 39 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 diverse team and 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 ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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 ViiV's Transparency Reporting For the Record site.