Pharmaceutical Dossiers Consultant

Programme & Policy

Overview

Conduct comprehensive review and assessment of pharmaceutical dossiers.

You have:

• 15 years of experience in quality management systems for pharmaceutical manufacturing, production processes and inspections, technical files review, clinical trial review, and assessment of clinical safety and efficacy data.
• 10 years of experience in writing technical documents, evaluation reports and conducting workshops and meetings.
• At least 3 completed projects of similar nature and scope in various countries.
• Fluency in English as demonstrated through previous formal training, qualifications, or work experience.
• Willingness to comply with UNRWA's confidentiality and conflict of interest rules.
• Willingness to work under a staff augmentation modality.
• Qualifications and training in fields such as Pharmaceutical Industry, Clinical Research, Regulatory, and Post-market Surveillance.

Result of Service This comprehensive review process ensures that each dossier, comprising draft guidelines and checklists, is meticulously assessed, resulting in a well-documented assessment report with actionable recommendations. Additionally, contribute to the development and presentation of capacity-building workshops and training sessions for UNRWA staff. Estimated Number of Dossiers: 400 dossiers as a minimum requirement. The project will span three months, during which the review of all dossiers and the delivery of training sessions will take place.

Work Location UNRWA

Expected duration 3 months

Duties and Responsibilities 1. Reviewing applicants' documentation electronically provided to UNRWA to ensure compliance with quality assurance and technical requirements, as well as the latest versions of specifications. 2. Conducting a comprehensive assessment and review of all technical data and documents concerning product safety, manufacturing processes, risk management, and production capacities. 3. Verifying basic information about the manufacturer's regulatory and legal standing in their respective country. 4. Reviewing and verifying all certifications, licenses, and approvals submitted by applicants. 5. Preparing a document assessment report with clear recommendations for prequalification applicants, outlining the next steps for factory inspection if requirements have been met and needed. 6. Conducting additional document reviews of manufacturer and/or product reports as requested. 7. Providing draft guidelines and check lists commissioned by UNRWA within agreed timeframes. 8. Conducting capacity-building workshops, including training and workshops for program managers, procurement staff, and health personnel, covering the technical aspects of the prequalification process.

Qualifications/special skills Qualified consultants should possess the following qualifications and experience: 1. Qualifications and training in fields such as Pharmaceutical Industry, Clinical Research, Regulatory, and Post-market Surveillance. 2. At least 15 years of experience in one or more of the following: quality management systems for pharmaceutical manufacturing, production processes and inspections, technical files review, clinical trial review, and assessment of clinical safety and efficacy data. 3. At least 10 years of experience in writing technical documents, evaluation reports and conducting workshops and meetings. 4. At least 3 completed projects of similar nature and scope in various countries. 5. Fluency in English as demonstrated through previous formal training, qualifications, or work experience. 6. Willingness to comply with UNRWA’s confidentiality and conflict of interest rules. 7. Willingness to work under a staff augmentation modality 1. Qualifications and training in fields such as Pharmaceutical Industry, Clinical Research, Regulatory, and Post-market Surveillance

Languages Excellence command of written & spoken English

No Fee THE UNITED NATIONS DOES NOT CHARGE A FEE AT ANY STAGE OF THE RECRUITMENT PROCESS (APPLICATION, INTERVIEW MEETING, PROCESSING, OR TRAINING). THE UNITED NATIONS DOES NOT CONCERN ITSELF WITH INFORMATION ON APPLICANTS’ BANK ACCOUNTS.

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Potential interview questions

Added 2 years ago - Updated 1 year ago - Source: careers.un.org