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Technical Advisor, RSS-Safety/Efficacy, Bioequivalence, CRO

Employer
United States Pharmacopeia
Location
Rockville, MD
Start date
May 20, 2022

View more

Discipline
Administration, Clinical, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

Summary of the Position

The Technical Advisor, Regulatory Systems Strengthening (RSS) is a key technical position within the Promoting the Quality of Medicines Plus (PQM+) program.  The technical advisor is a primary contributor to the PQM+ center of excellence for RSS in close coordination with the existing Technical Advisor - RSS and supports the Sr. Technical Advisor in providing oversight of the global implementation of RSS activities. The main focus areas of expertise in this role include finished pharmaceutical and biological products’ safety and efficacy requirements and guidelines of common technical document (CTD) from both scientific and regulatory perspectives. In addition, the incumbent will serve as a subject matter expert in product dossier evaluation on clinical data and results and the bioavailability and bioequivalence (BA/BE). The technical advisor will also be the technical focal point for clinical practices (GCP) and good laboratory practices (GLP) and regulatory requirements for contract research organizations (CROs) that conduct BA/BE studies. The Technical Advisor will coordinate closely with the Chemistry, Manufacturing and Control Technical team and the Laboratory Quality Management System, Quality Assurance and Quality Control Technical team to complement each other’s work. When required he/she will act on behalf of the Sr. Technical Advisor when interfacing with global experts and leaders in RSS and will be required to develop and disseminate new content to advance global knowledge on sustainably increasing the supply of essential medicines.

Roles and Responsibilities

• Contributes to defining and refining the program’s RSS policy, strategy and approach to ensure alignment with international best-practices.  

• Leads the adoption and deployment of data standards on market authorization regulatory function by country national medicines regulatory agencies (NMRAs) as well as their regional networks. 

• Contributes to advocating the adoption and deployment of program tools, including integrated regulatory information management system (IRIMS) to technical staff in the field as well as the country NMRAs.  

• Provides consistent, high-quality and results-driven technical assistance provision for relevant global and regional activities identifying and delivering continuous improvements based on new evidence/ information and programmatic experience. 

• Actively takes part in the team to deliver technical assistance to regulatory authorities and support technical staff, regional/ local partners and consultants involved in delivery of trainings on priority medicines product dossier evaluation for registration/market authorization.   

• Leads in developing training materials on GCP and GLP (in coordination with the Laboratory Services Team) and delivering trainings for CROs clients.

• Leads in providing direct and hand-on technical assistance support to CROs that conduct BA/BE studies on priority pharmaceutical finished products of interested of USAID and PQM+ program.

• Leads in advocating and support for countries to adopt and implement the data standards relevant to clinical trials, BA/BE as well as the regulatory clinical trials oversight function of NMRA.   

• Works with the Chemistry, Manufacturing and Control (CMC) team in support to manufacturers towards achieving Expert Review Panel status and WHO Prequalification for products requiring BE studies. 

• Actively contributes to annual programmatic and resource planning process and to the development of quarterly and annual reports.

• Reviews and provides timely technical inputs into key project deliverables including work plans and reports (e.g., technical and donor reports).

• Flags technical project challenges, risks and issues, elevating them to the Sr. Technical Advisor and Project Management Lead as needed.

• Interfaces regularly with external stakeholders/groups in relevant areas as needed including, with WHO pre-qualification team, regulatory forums/ authorities, and other leaders in health system strengthening.  

Basic Qualifications

• Bachelor's degree in pharmaceutical science, chemistry, engineering or public health required

• 5 years’ experience in regulatory affairs in pharmaceutical and biological products dossier assessment of safety and efficacy data 

Preferred Qualifications

• Working experience with assessment tools (e.g., WHO Global Benchmarking Tool – GBT) to evaluate key functions especially the market authorization of a medicines regulatory authority  

• Demonstrated experience in developing and implementing regulatory systems strengthening interventions in low-and middle-income countries (LMICs)

• Knowledge of international regulatory guidelines (e.g., of World Health Organization (WHO), International Conference on Harmonization (ICH), Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Medicines Agency (EMA), Food and Drug Administration (FDA), International Organization for Standardization (ISO), etc.)

• Strong written (especially technical writing) and oral communication skills 

• Willingness to travel at least 25% of the time

• Direct experience implementing USAID-funded programs 

• Subject matter expert (6+ years’ experience) in pharmaceutical product registration, inspection, and quality post-market surveillance in LMICs  

• Fluency in French

Supervisory Responsibilities

None

 

 

COVID-19 Provisions: 

 

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 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.

 

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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