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Senior Technical Advisor (Technical Lead), RSS

Employer
United States Pharmacopeia
Location
Rockville, MD
Start date
Nov 28, 2023

Job Details

Description

Who is USP?

The U.S. Pharmacopeial Convention (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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

Brief Job Overview

The Senior Technical Advisor and Technical Lead for Regulatory System Strengthening (RSS) is a key position within the Promoting the Quality of Medicines Plus (PQM+) program. They provide strategic direction and overall technical oversight to PQM+ RSS activities ensuring their realization of program objectives. The Senior Technical Advisor advises USAID and PQM+ leadership on all matters related to strengthening country and regional regulatory systems for quality assurance of medical products and to the improvement of their governance and transparency practices. They collaborate with other Team Leads to promote and optimize financial resources for quality assurance and to advance the global medical product quality assurance learning agenda. They assure the adequate staffing and supervision of the RSS team ensuring coverage to the different RSS technical areas. They direct program resources to strengthening regulatory functions as delineated by the WHO GBT with emphasis on market authorization (MA), post marketing surveillance (PMS), regulatory inspections, and pharmacovigilance in low and middle-income countries (LMICs). The Senior Technical Advisor also promotes the advancement of regulatory governance, transparency, and regional harmonization. They collaborate and dialogues with global institutions and program partners especially with WHO to advance regulatory authorities in LMICs towards stable, well-functioning, and integrated regulatory systems. They will also participate in RSS global and regional forums promoting PQM+ as a thought-leader in the domain of RSS.

How will YOU create impact here at USP?

Provide leadership in defining and developing RSS technical strategies, approaches, and tools that align with international standards for medical products regulation (such as those from WHO, ICH, PIC/S, ISO, USP, and other recognized standards) necessary for the delivery of PQM+ RSS technical assistance.

Lead and oversee RSS technical team efforts for the development and review of program annual workplan activities and budgets ensuring adequacy of their design in fulfilling program intended results.

Support countries to adopt new and emerging regulatory pathways (such as EUA, FRP, and CRP) and efficient regulatory approaches (such as joint reviews, reliance, and recognition) and to develop their regulatory science capacity to ensure timely approval and life cycle monitoring for the quality, safety, and effectiveness of medical products in their market.

Establish collaborative workstreams and share technical resources and tools with the PQM+ CMC & Vaccine team to support their successful delivery of technical assistance to manufacturers to achieve international standards and stringent approvals and/or WHO prequalification of medical products.

Collaborate with PQM+ countries to oversee the implementation of RSS activities and to ensure the adequate deployment of needed resources and tools for the delivery of technical assistance aimed at supporting countries regulatory agencies to progress towards higher WHO maturity levels.

Lead the development, deployment and continuous improvement of strategy and approaches to advance regulatory harmonization in Asia and Africa.

Work closely with PQM+ Senior Workforce Development Advisor to promote sustainable development of regulatory workforce, including the development of university curricula, in-service trainings, and capacity development programs.

Collaborate with MEL team to ensure the development and deployment of effective RSS indicators and for program reporting on RSS activities.

Act as PQM+ focal point to WHO and engage in the planning of joint technical assistance activities such as workshops/trainings.

In collaboration with PQM+ communication team, develop and oversee implementation of documentation and dissemination plans that capture RSS lessons learned, success stories, best practices and program adopted approaches.

Supervise RSS staff effectively; also, lead and mentor staff through the organization of RSS community of practice, knowledge sharing, and south-to-south technical assistance.

Oversee the work of PQM+ partners and consultants ensuring timely completion and quality standards of their deliverables.

Represent USP and PQM+ in conferences and meetings of interest and deliver presentations that promote PQM+ work in the field of RSS.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to

excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility

with stakeholders, along with the following competencies and experience:

Basic Qualifications

Masters degree in international regulatory affairs, pharmaceutical sciences, chemistry, public health,

or related field

Experience in dossier submission and review practices of WHO, FDA, and other stringent agencies.

Previous experience in the deployment of international standards such as those from WHO, ICH,

PIC/S, ISO, USP, etc. to support LMIC regulatory agencies.

Expertise in the development of manuals, SOPs, and quality management systems to support the

delivery of regulatory functions.

Eight (8) years in designing and implementing projects that contribute to stronger health systems and

improve health outcomes in low- and middle-income countries.

Three (3) years people management experience and skills, including ability to seamlessly manage

virtual teams and work in a matrixed organization.

Skills Sought

Demonstrated experience in developing and implementing regulatory systems strengthening

interventions obtained from working with national regulatory authorities or with implementing

partners.

Demonstrated experience in one or more of the following disease areas: HIV/ AIDS, malaria, TB,

NTDs, AMR, MNCH

Direct experience implementing USAID-funded programs.

Strong written (especially technical writing) and oral communication skills with strong ability to

dialogue and interact effectively with high-level officials.

Willingness to travel at least 25% of the time.

Additional Desired Preferences

Doctoral degree in regulatory affairs, pharmaceutical sciences, chemistry, public health, or related

field

Previous work as a regulator with experiences in market authorization and review, regulatory

inspection, post marketing surveillance, and in crosscutting areas including harmonization, reliance,

and recognition.

Direct experience with and understanding of the WHO Global Benchmarking Tool

Fluent in French

Supervisory Responsibilities

The Senior Technical Advisor, RSS (Technical Lead) supervises:

Senior Technical Advisor, RSS/MA

Senior Technical Advisor, RSS/PMS

Senior Regional Technical Advisor, RSS

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved.

Your recruiter will advise accordingly.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workfrom the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Note : 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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)

Job Category Technical Programs

Job Type Full-Time

Company

USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. We do this through establishing public scientific standards and programs that help ensure billons of people around the world have access to safe and quality products.

USP aspires to be a diverse, inclusive, innovative, and engaging organization that empowers and engages staff and volunteers to contribute to its mission to improve global health. We are committed to creating a culture where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, family status, and where they can contribute their full potential to accomplish our mission.

At USP, you’ll join a talented and diverse team of 1,200 scientific, technical and public health professions, working in state-of-the-art facilities and collaborating with the world’s leading experts from industry, academia, healthcare, and government to address public health challenges and advance cutting-edge innovation.

Whether you’re helping to establish new USP standards, creating key resources to address emerging health issues, or providing critical technical assistance in the developing countries, you’ll be inspired by the positive impact your work has on building public trust and a healthier tomorrow.

Company info
Website
Location
12601 Twinbrook Parkway
Rockville
Maryland
20852
United States

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