20 beste vacatures voor de functie van regulatory specialist in utrecht, ut (nieuwe medewerkers gezocht)

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Clinical Product Specialist - The Netherlands
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ViCentra B.V. —Utrecht
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Master Thesis Project | ECDSA Zero-Knowledge Credentials in Yivi’s EUDI Wallet
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Working as a Senior Insurance and Actuarial Consultant
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Oikocredit International —Amersfoort
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Ik wil de nieuwste vacature-alerts ontvangen voor de functie van regulatory specialist in utrecht, ut

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Regulatory and Start Up Specialist - Netherlands

IQVIA -
Utrecht

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Vacaturegegevens

Fulltime
8 dagen geleden

Volledige vacaturetekst

Utrecht, Netherlands | Full time | Home-based | R1547012

Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Home Based role - requiring Dutch language fluency and local submissions as well as contract negotiations experience.

Essential Functions
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.

Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.

Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines.

Ensure monitoring measures are in place and implement contingency plan as needed.

Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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regulatory specialist vacatures in utrecht, ut

Regulatory and Start Up Specialist - Netherlands

Packaging Regulatory Specialist

Business Continuity Specialist

Regulatory Affairs Specialist, Post Market (32 - 40hrs per week)

Senior Rewards Specialist

Senior CMC Specialist, Analytical

QA Specialist - QMS

Clinical Product Specialist - The Netherlands

Contract Specialist

VP Fraud Risk Intelligence

Compliance Supervisor Outside Service Providers - UPS, Nederland

Account Manager - Western Netherlands

HR Consultant – Bulgarian Language Required

Third Party Security Advisor

Consultant - Business and Technology NL

SAP BTP Integration Specialist

Sales representative — Pharmaceutical industry

Master Thesis Project | ECDSA Zero-Knowledge Credentials in Yivi’s EUDI Wallet

Working as a Senior Insurance and Actuarial Consultant

Performance Marketeer

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van regulatory specialist in utrecht, ut

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