The U.S. Pharmacopeial Convention (USP) Senior Regulatory Systems Strengthening Manager in Rockville, Maryland
Summary of the Position
The Senior Regulatory Systems Strengthening Manager is responsible for developing evidence-based approaches, developing and implementing USP Global Health activities on regulatory systems strengthening (RSS) for medical products (e.g., pharmaceuticals and medical devices), and contribute to advancing thought leadership. The selected individual will assist the Global Health and Manufacturing Services (GHMS) division for all RSS-related activities including market authorization, governance and policy, market surveillance, with an emphasis on pharmacovigilance. The success of this role will be measured through the development of sound technical programs, support to new business, production of white papers and other content, and representation at global working groups and at conferences. The position will work collaboratively across the GHMS division.
Roles and Responsibilities
Provide technical oversight for global health projects related to RSS
Identify, review, develop and continuously improve technical approaches to GHMS core areas to improve regulatory systems-based approaches and thought leadership
Identify new and adjacent areas in RSS for GHMS to contribute by identifying needs, developing plans
Prioritize and develop selected technical areas of expertise/experience/interest
Engage with other experts on technical program impact
Improve visibility of GHMS work by identifying conferences, writing abstracts, making presentations
New Business Technical Inputs
Monitor and identify areas to prioritize for technical offerings by reviewing relevant global trends and donor investments (as tracked by business development), including GFATM, World Bank, Gates, USAID, and others to identify unmet needs and propose solutions
Liaise with the new business unit to support day-to-day needs
Act as technical lead in developing proposals involving RSS
Assist the team in donor-funded/sub-role programmatic activities relevant to regulatory systems
Support donor engagement/prime engagement by attending/leading areas
Mentor junior or in-country staff/students when needed
Support onboarding of new staff who need technical orientation
B.S. in regulatory affairs, pharmaceutical sciences, chemistry, public health or related field
Eight (8) years in designing and implementing projects that contribute to stronger health systems and improve health outcomes in low- and middle-income countries, including at least six years’ experience in regulatory system strengthening and two years of cumulative experience in pharmacovigilance
Demonstrated experience engaging with and contributing to global pharmaceutical stakeholders and systems agenda and programs.
Demonstrated success working effectively with multidisciplinary and international project teams.
Established success in designing donor-funded projects in the pharmaceutical space.
Excellent oral, written and presentation skills in English
Ability to travel up to 25%.
M.S. in regulatory affairs, pharmaceutical sciences, chemistry, public health or related field
A PhD in pharmacy, pharmaceutical sciences, chemistry, public health or related field is preferred
Direct experience with and understanding of the WHO Global Benchmarking Tool
Excellent oral, written and presentation skills in French.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Technical Programs
Job Type Full-Time