8 publicaciones de empleo destacadas de coordinator, gss en argentina (¡Están contratando!)

Regulatory Specialist
KPS Life —Desde casa
2d
Technical Project Manager
EPAM Systems, Inc. —Desde casa
4d
Solution Architect
EPAM Systems, Inc. —Desde casa
Salesforce Architect
EPAM Systems, Inc. —Desde casa
Solution Architect (.NET)
EPAM Systems, Inc. —Desde casa
AI Implementation Engineer
Sovos Compliance —San Miguel de Tucumán, Tucumán
Postulación rápida
API & Integration Architect
EPAM Systems, Inc. —Desde casa
Junior Commercial Projects Coordinator
CIAL D&B Services Inc —Capital Federal, Buenos Aires
- Tiempo completo
Postulación rápida

More jobs to discover

Find similar jobs that you might be interested in.

Technical Project Manager Tether Wallet (100% Remote Worldwide)
Tether Operations Limited —Buenos Aires, Buenos Aires
Translates between technical and non-technical stakeholders. 4+ years in project management, technical project management, scrum master, product owner, or…
Technical Project Manager
EPAM Systems, Inc. —Desde casa
Contribute to reducing technical debt and enforcing project standards across the development lifecycle. Participation in a minimum of 2 full-cycle projects, or…
4d

Quiero recibir la alerta de empleo más reciente para coordinator, gss en argentina

Al ingresar a tu cuenta, aceptas las Condiciones del servicio de SimplyHired y das tu consentimiento a nuestra Política de privacidad y Cookies.

Regulatory Specialist

KPS Life -
Desde casa

Postulate ahora

Detalles del empleo

Hace 2 días

Descripción completa del empleo

Opportunity Details

On Assignment Regulatory Specialist

Remote - Argentina

The Regulatory Specialist is responsible for managing the coordination, preparation, and review of clinical regulatory documents, including the tracking and reporting of key performance by site and study. prepares and/or reviews submissions for clinical studies to local or central IRB/EC and regulatory authorities, as appropriate, in an ongoing manner maintaining compliance with local state/province or country laws and regulations.

Responsibilities:

Supports study startup and regulatory activities, including but not limited to obtaining and maintaining regulatory and ethics approvals
Creates master-level regulatory package for submissions for Regulatory Agencies
Supports in-house regulatory submission(s) to Regulatory Agencies
Supports creation of startup plans and essential documents checklists for assigned studies
Prepares ongoing submissions and periodic notifications required by central and local IRB/EC, regulatory authorities, and other local regulatory authorities as needed; includes safety notifications as required by local laws/guidelines
Reviews Master Informed ICFs to ensure all country-specific requirements are met
Supports the development of country-specific ICFs as required by the protocols, utilizing translation vendors as necessary
Creates essential document packages to sites and checks for completion
Supports site submissions to local IRBs (provides site packages submits to central IRB)
Confirms greenlight for site activation
Initiates performance tracking (risk mitigation, corrective actions, lessons learned) for study
Participates in study team meetings and provides start up status and regulatory approval updates
Provides regulatory guidance to ensure compliance with applicable regulations and requirements
Escalates regulatory, timeline, or other concerns to study team
Maintains continuous awareness of local/country agency changes in regulatory processes, timelines, and required documentation
Supports study teams during internal study audits and/or other process improvement activities
Supports study teams for and/or during mock and actual inspections by regulatory authorities

Education and Requirements

Bachelor’s Degree in a related field, or equivalent combination of training, education, and work experience
At least 3 years of experience in a regulatory role in a pharmaceutical or CRO environment
Extensive experience as site regulatory coordinator a plus
Previous administrative work experience, preferably in an international clinical research setting
Extensive knowledge of FDA GCP-ICH Guidelines and local regulatory requirements
Ability to demonstrate a high level of competency relating to administrative and clerical responsibilities, procedures, and systems
Ability to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance

Postulate ahora

Refiná tu búsqueda

coordinator, gss empleos en argentina

Regulatory Specialist

Technical Project Manager

Solution Architect

Salesforce Architect

Solution Architect (.NET)

AI Implementation Engineer

API & Integration Architect

Junior Commercial Projects Coordinator

More jobs to discover

Quiero recibir la alerta de empleo más reciente para coordinator, gss en argentina

Related Searches

Opportunity Details

Herramientas para candidatos

Herramientas para empresas

Explorar

Mantente conectado