PMDA MHLW NDA 1. NDA US EU PMDA PMDAPMDA NDA CTDNDA ODD 2. CRO 10 PMDA JNDACTD PMDA Microsoft Excel WordPower Point

Using Microsoft Azure data PaaS services, design, build, modify, and support data pipelines leveraging DataBricks and PowerBI in a medallion architecture setting. If necessary, create prototypes to validate proposed ideas and solicit input from stakeholders. Excellent grasp of and expertise with test driven development and continuous integration processes. Analysis and De

Fur unser Depot Team stellen wir ab sofort Mitarbeiter (m/w/d) fur die Durchfuhrung von Depot und Produktionstatigkeiten im Zusammenhang mit Materialien fur klinischen Studien ein. Hierbei ist die Gewahrleistung der Einhaltung der internen Richtlinien des Unternehmens sowie der behordlichen und regulatorischen Richtlinien von groter Bedeutung. Die Ausfuhrung aller depotbe

Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys

Our Senior IT Support representative is responsible for all support queries across the Data & Technology departments, working with a variety of users to resolve their technical issues in a prompt and efficient manner, whilst maintaining a positive customer experience as well as providing guidance and assistance to members of the site services team. Key Accountabilities Ac

As a Pharmaceutical Services Specialist , you will assist in the conduct of Phase I studies within Pharmaceutical Services area in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP's). You will assist and participate in the assembly /dispensing of Investigational Medicinal Product (

Support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QMSO leadership to assess and report on the functioning of components constituting the QMS. Supporting Activities QMSO Support As assigned, complete QMSO goals for the key QMS elements. Maintain a familiarity with Parexel QMS related applications an

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what w

1. monthly closing for China statutory book 2. monthly quarterly tax filing related work 3. investigator drop file upload 4. account reconciliations 5. Statutory audit work

CRA 1 Key Accountabilities Start up (from site identification through pre initiation) Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start up phase. Build relationships with investigators and site staff. Conduct, drive and manage country specific feasibility and/or site pre qualification and qualification acti

The Research Associate position is a great opportunity for those with a passion in research! The Research Associate position is an excellent opportunity for an individual who is interested in beginning a career in research, conducting unique first in human, Phase I clinical research trials within multiple therapeutics. By being hired into one of our Research Associate job

The main responsibility of the Site Contract Leader is the negotiation of study specific, generic, site specific and country Clinical Site Agreements (CSA) and any other agreement that is required for the completion of the Site Initiation Visit (SIV). The Site Contract Leader is also responsible for managing CSA activities and liaising with study specific stakeholders to

Site Feasibility Liaison1 Sr.CRACRA II 1 Web CRO / 1

We are looking for a Senior Regulator y Affairs Associate to join our growing team in Romania. This role can be either home or office based in Bucharest. As a Senior Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trail Applications (CTA) from various European locati

Quality managementQC Microsoft Word 20243 20182023 //// 2 20231022024329 9 00 18 00 12/28 1/3