Senior Regulatory Systems Strengthening Manager, Rockville, United States 104 views

Description

The Senior Regulatory Systems Strengthening Manager is responsible for developing evidence-based approaches, developing and implementing USP Global Health activities on regulatory services strengthening (RSS) for pharmaceuticals, and providing assistance in activities to support thought leadership activities. 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

Technical Support

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

Programmatic/Administrative Support

Assist the team in donor-funded/sub-role programmatic activities relevant to regulatory systems

Support donor engagement/prime engagement by attending/leading areas

Tags

business development

covid

family health

global health

health outcomes

health systems

manufacturing

pharmacy

Mentor Role

Mentor junior or in-country staff/students when needed

Support onboarding of new staff who need technical orientation

Basic Qualifications

BS. 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

Skills Sought

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%.

Preferred Qualifications

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.

Supervisory Responsibilities

N/A

COVID-19 Provisions

The following COVID-19 provisions will apply to selected candidate(s) hired:

As a condition of employment with United States Pharmacopeial Convention’s (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1

st

, 2021 are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

USP offers an impressive benefits package, including:

Generous paid time off – 15 paid holidays, 10 sick days and 15 vacation days per year to start

An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately

Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles.

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

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 Categories Technical Programs

Job Types Full-Time

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