Regulatory Affairs Associate

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico. **Responsibilities**: Assisting with the preparation of LATAM Marketing Authorization Applications Preparation and submission of documentation for post-authorization activities Compile Dossier as per country requirements Education &...

An Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and Supervisor, taking...

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

Act as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...

Supports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...

Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...

Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

Summarized Purpose: Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists with allocation of work tasks to safety reporting team...

Study start up associates are integral in ensuring that clinical research sites are prepared and have the necessary tools and approvals needed to start the trial. As a study start up associate at ICON working in contracts your main role is to review and negotiate clinical site investigator contracts and budgets. Maintain communication with Investigative...

**At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients’ lives.** **Our** **‘Own It’** **culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability &...

IQVIA Biotech, a global full service CRO providing flexible and tailored clinical solutions to smaller biotech companies, is seeking additional talent within our **Site File Operations team**. Our **Site File Specialist II **opportunity requires: BS/BA/BSc, or equivalent, plus 2 years of related experience; regulatory document review experience preferred....

We are looking for a **D365 F&O Functional Consultant **to join our team. The position will work **REMOTELY.** **Required Skills**: - 3 to 5 years of experience. - Effective spoken and written communication. - Analysis and problem solving. - Self-drive and proactiveness. - Time management. - Experience using SuresStep. - Business process and workflow...

We are looking for a **D365 F&O Functional Consultant **to join our team. The position will work **REMOTELY.** **Required Skills**: - 3 to 5 years of experience. - Effective spoken and written communication. - Analysis and problem solving. - Self-drive and proactiveness. - Time management. - Experience using SuresStep. - Business process and workflow...

**Education and Experience**: - Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or - Direct experience in safety/Pharmacovigilance (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate...

This newly created position at Turnitin will report to the VP, Deputy General Counsel and will be a key member of the Turnitin legal team. The attorney will assist with critical legal support and guidance on commercial, transactional, IP, employment and real estate matters in North America and LATAM with a focus on supporting the legal aspects of the entire...

**Job Overview** Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and...