Senior Program Officer Global Regulatory Affairs - Beijing, 中国 - Gates Foundation

描述

The Foundation

We are the largest nonprofitfighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve.We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities.As a workplace, were committed to creating an environment for you to thrive both personally and professionally.

The Team

The Health Innovation and Partnership (HIP) Team in the China Country Office advances global health through scientific discovery, technological innovation and public/private partnerships. We focus on health problems significantly impacting developing countries with limited attention and funding. We work with our partners to accelerate research translation, development, and commercialization of medical products (pharma, vaccines, diagnostics, and vector control products). We support global strategies to prevent, control, and eliminate priority infectious diseases, including vaccine preventable diseases, malaria, tuberculosis, HIV, and pneumonia, and develop interventions to improve maternal, neonatal, and child health (MNCH). We work closely with and support functional teams in Discovery & Translational Sciences, Vaccine Development, and Integrated Development as well as selected program strategy teams (PSTs), including Malaria, TB/HIV, pneumonia, NMCH Discovery & Tools, and the Enteric, diagnostics, genomics & epidemiology team.

This position reports to the Deputy Director of Health Innovation and Partnerships (HIP).

Application deadline: 17th November, 2023.

Your Role

The Senior Program Officer Global Regulatory Affairs is responsible for developing and managing a portfolio of grants focused on optimizing the process of translating innovations into healthcare and related products (pharmaceuticals, vaccines, biologics, diagnostics, nutritional products, and vector control products) that can be legally marketed in developing countries. The Senior Program Officer will work primarily with Chinas National Medical Products Administration to accelerate medical product development but will also have a global technical and policy component to support global clinical or field trials, and to facilitate global access of the products, including through pre-qualification by the World Health Organization or other regulatory operations. The candidate will work with various internal and external partners including PSTs, pharmaceutical industry, biotechnology companies, academic research institutions and governmental and non-governmental funders, Product Development Partners (PDPs) and other foundation partners. The candidate should have strong regulatory affairs experience involving in drugs or vaccines, or other health products such as biologics, devices, and diagnostics, and should be ready to apply skills to a diverse product portfolio for global health.

All activities require the ability to develop and implement grants and work plans, and the ability to work in close collaboration with multiple external partners and with internal colleagues to ensure the integration and coordination of their work with the foundation's overall global health strategy. The officer will also contribute significantly to strategy shaping and execution. Primary responsibilities are listed below.

What Youll Do

• Negotiate, plan, develop, implement a portfolio of grants or performance-based contracts, including aligning with partners, co-creating end-to-end development framework and staged milestones, reviewing inquiries and grant proposals, and providing clear, concise, and insightful written analyses and recommendations for funding.
• Apply strategic and regulatory expertise to optimize integrated clinical development plans for various products such as vaccines, drugs, biologics, devices, and diagnostics.
• Work collaboratively across the functional teams, PSTs, and with foundation partners and grantees to plan and support clinical development programs in China and overseas.
• Consult, provide thought partnership, and support grantees to increase the impact of projects and the creation of well-integrated product development plans to generate data for global access.
• Manage information related to grant portfolios and domain-level data, such as documenting key activities and decisions; inputting into key business processes and performance measurement tools; preparing materials for communication with foundation leadership.
• Proactively identify areas of alignment in collaboration with other Gates Foundation teams.
• This role will require the ability to travel up to 30% domestically and internationally.

Your Experience

The ideal candidate is someone who enjoys the opportunity to work on complex projects and collaboratively craft solutions that have potential for transformational change. We seek a self-motivator who can integrate a diverse set of perspectives to build consensus, structure, drive progress, and provide technical and operational capacity to the product development portfolio. You should have the following experience:

• Technical expert in the regulatory domain including processes and tools and up-to-date knowledge of regulatory changes.
• Minimum 7 years of professional experience in the biotech or pharmaceutical industries, and global work experience strongly preferred.
• Masters degree with exceptional experience, or MD or PhD with experience in supporting more than one group of products I desirable.
• Demonstrated ability to quickly learn new disease areas and new technologies;
• Demonstrated excellence in scientific writing, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience;
• Demonstrated ability to work with flexibility, efficiency, and passion in a fast-paced environment;
• Proven program and partner management skills: ability to coordinate inputs from many people; to track progress against targets and identify barriers to progress; to plan agendas and facilitate meetings; and to organize, evaluate, and communicate information.

Other Attributes

• Experience developing and implementing projects involving global partners preferred.
• Experience in regulatory affairs and medical affairs, from research and clinical development to post-marketing and life-cycle management (including marketing authorizations) for vaccines, medicines, diagnostics, and/or vector control products preferred. Significant knowledge about medical products regulatory issues in developing countries and global regulatory ecosystem preferred.
• Strong problem solving and strategy development experience.
• Experience in a role requiring collaboration (both internally and externally), prioritization and results-orientation in a fast-paced, complex organization.
• Exceptional listening, verbal, and written communication skills, able to effectively calibrate input and synthesize information to connect with diverse audiences.
• Demonstrated passion for the Foundations values with a commitment to deliver results.
• Fluency in both Chinese and English languages required.

*Must be able to legally work in China without visa sponsorship.

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Hiring Requirements

As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

Candidate Accommodations

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Inclusion Statement

We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion of voices, ideas, and approaches and we support this diversity through all our employment practices.

All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.

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