Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Clinical Data Management, eCRF Design, EDC Databases, Medidata Rave, Oracle InForm
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Clinical Research, Pharmacovigilance, Clinical Development Planning, Regulatory Compliance
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Plans
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Clinical Research, Pharmacovigilance, Clinical Data Analysis, Regulatory Compliance
Hong Kong, Hong Kong Island, Hong Kong S.A.R. · On-site
Senior
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Plans
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Planning
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Plans
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Clinical Research, Gastroenterology, Pharmacovigilance, Clinical Development Planning
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Data Analysis
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Plans
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global re…
Skills: Medical Monitoring, Gastroenterology, Clinical Research, Pharmacovigilance, Clinical Development Planning
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 dri…
Site Management Associate (Japanese Skill required)
Bangkok, Thailand · On-site
Mid level
Company Description PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a g…
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together approximately 3,000…
Skills: Business Development, Sales Strategy, Account Management, Prospecting, Salesforce
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more 3,000 driven, …
Company Description PSI is a leading Contract Research Organization with 30 years on the market, offering a perfect balance between stability and innovation for both clients and employees. We focus on delivering high-qua…
Company Description PSI is a leading Contract Research Organization with 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality …
Skills: Clinical Project Management, Site Monitoring, Team Leadership, Quality Compliance, Vendor Management
Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…
Company Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on deliveri…
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Full-time
bachelor degree
Posted 17d ago
~40 hrs/week
Responsibilities
Prepare and manage clinical trial submission dossiers for regulatory and ethics authorities in Kazakhstan. Coordinate with project teams, vendors, and authorities to facilitate the start of research projects for novel medicinal products.
Requirements
Requires a university degree and prior experience with clinical trial submissions specifically within Kazakhstan. Must be proficient in English and Kazakh with strong attention to detail and communication skills.
Full job description
Company Description
PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.
We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products in Kazakhstan, while taking a step further in your professional career.
Office-based in Almaty
You will:
Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
Review translations of essential documents subject to clinical trial submission
Track the regulatory project documentation flow
Review documents to greenlight IP release to sites
Manage safety reporting to authorities
Deliver regulatory training to project teams
Assist with feasibility research and business development requests
Qualifications
College/University degree or an equivalent combination of education, training and experience
Clinical trial industry experience
Prior experience with clinical trial submissions in Kazakhstan
Full working proficiency in English and Kazakh
Proficiency in MS Office applications
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3