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Technical Advisor

Employer
United States Pharmacopeia
Location
Rockville, MD
Start date
Nov 11, 2022
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Job Details

Description

Summary of the Position

USP was awarded the Promoting the Quality of Medicines Plus (PQM+), a USAID-funded global program designed to sustainably strengthen medical product quality assurance systems in low-and-middle income countries (LMICs). PQM+ is currently seeking a Technical Advisor- Regulatory Systems Strengthening (RSS) with focus on Post-Marketing Surveillance (PMS). The Advisor will provide technical assistance to the medicines regulatory authorities and Ministries of Health in target PQM+ countries with oversight from the Technical Advisor RSS Market Surveillance and Control while working in close coordination and collaboration with the regional/country Technical Advisor(s) in Asia and Africa. The incumbents prime responsibility is to provide technical guidance and assistance in the implementation of PMS / Risk-based PMS strategies and programs as part of an overall effort for strengthening regulatory system capacity. The Advisor will adapt/adopt the PQM+ approach and other internationally recognized standards and practices to ensure the quality of medical products circulating in target countries and/or region(s). He/she must possess a deep understanding of the pharmaceutical regulatory environment in LMICs of Africa, Asia and/or other regions. The position will be based at USP HQ in Rockville, Maryland, USA.

Roles and Responsibilities

  • Contributes to defining and refining the programs RSS policy, strategy, legal framework, and approaches to ensure their alignment with international standards and best-practices.
  • Supports the establishment of PMS/RB-PMS in-country Technical Working Groups (PMS/RB-PMS TWG) and defining their roles and responsibilities.
  • Assists countries in developing and/or reviewing their policies, legal provisions, rules and regulations in the area of medicine regulation with focus on RB-PMS.
  • Facilitates development/revision of country specific RB-PMS guidelines (for medicines and Vaccines).
  • Provides support for the development of necessary protocols and SOPs for the implementation of RB-PMS.
  • Provides technical support to MRAs to ensure adequate Market Surveillance and Control function to attain WHO GBT Maturity Level 3.
  • Serves as a technical resource among the PQM+ technical RSS staff with focus on PMS activities.
  • Participates in the development of in-house training programs and their implementation ensuring sustainability and transfer of knowledge in the field of RSS and PMS.
  • Provides quality support to establish, implement and monitor progress of PMS/RB-PMS programs in PQM+-supported countries and regions, with priority to francophone countries.
  • Assists country programs, NMRAs and PMS-TWG in timely reporting of their PMS/RB-PMS results to the PQM+ MEL indicators.
  • Participates in operational/analytic research activities for RSS and contributes to the evaluation of RB-PMS activities.
  • Provides inputs to the development of PQM+ regulatory technical approaches and tools and participate in the training and coaching of newly hired country or HQ staff
  • Timely submission of activity reports and participates in knowledge management activities including the development of technical briefs, success stories, conference abstracts, etc.
  • Performs any other relevant assignments designated by the supervisor or RSS technical lead e.g., review technical reports and/or trip reports and documents.
  • Travels to countries as approved to perform assignments as described above.

Basic Qualifications

  • Bachelor's degree in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field.
  • Minimum of five years experience in pharmaceutical regulation, regulatory functions and particularly in market surveillance and control.
  • Solid knowledge of the norms on medical products quality and practices of pharmaceutical systems in Africa and Asia.

Skills Sought

  • Strong written (especially technical writing) and oral communication skills in both English and French.
  • Hands on experience in development and implementation of PMS/RB-PMS activities and programs at country and regional levels.
  • Direct experience with WHO global benchmarking tool and its deployment at country level.
  • Willingness to travel at least 25% of the time.

Preferred Qualifications

  • Masters degree in regulatory affairs, pharmacy, public health, pharmaceutical science, chemistry, engineering, or related field.
  • Eight years + experience in pharmaceutical regulation, regulatory functions and particularly in market surveillance and control.
  • Demonstrated experience working in key functions in an NMRA or organization providing technical assistance to strengthen medicines quality assurance systems.
  • Direct experience implementing USAID-funded programs.

COVID Provisions

As a condition of employment with United States Pharmacopeial Conventions (USP) duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after July 1st, 2021, are required to be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

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 are protected.

About USP

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 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.

Find Us
Website
Location
12601 Twinbrook Parkway
Rockville
Maryland
20852
US
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