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Regulatory Affairs Specialist

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Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

Main Responsibilities:

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Toxicologist

posted by: spj_bot

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join a dynamic and ambitious team supporting drug development programs from preclinical stages through market authorization. You will provide toxicology expertise related to impurity assessment, genotoxicity strategies, and health-based exposure limits within a highly collaborative and regulated environment.

Key Responsabilities :

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Clinical Trial Associate

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Key responsibilities :

Job Skills

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Clinical Scientist Oncologie

posted by: spj_bot

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

About You

Job Skills

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Clinical Scientist

posted by: spj_bot

About the Job

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will be a key player in supporting clinical trials and contributing to the advancement of clinical research projects.

You will work alongside cross-functional teams to ensure clinical studies are conducted in accordance with protocol, regulatory requirements, and company standards. Your role will involve reviewing clinical data, supporting medical monitoring activities, and contributing to the development and review of clinical trial documents.

  • Support clinical trial activities from study start-up to close-out, ensuring adherence to clinical and regulatory standards.
  • Contribute to the preparation and review of protocols, informed consent forms, and amendments.
  • Perform medical review of clinical data, including patient profiles and adverse event narratives.
  • Collaborate with pharmacovigilance, clinical operations, and biostatistics teams for data review and interpretation.
  • Assist in medical writing and review of study-related documents such as clinical study reports and briefing documents.
  • Ensure proper documentation and filing of study-related materials into Trial Master Files.
  • Support preparation for audits, inspections, and regulatory submissions.

Requirements

Job Skills

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Data Scientist

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data Management. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

We are looking for experienced Data Scientists to support innovative Drug Discovery programs within a leading pharmaceutical research environment.

The selected candidates will work with multidisciplinary teams including biologists, chemists, data scientists and project leaders to accelerate therapeutic projects through data-driven and in silico approaches.

 

 

Main Responsibilities

Job Skills

drug discovery professional datasets msc decision make mathematical modelling predictive modelling data integration literature review research clinical research scientific literature artificial intelligence service provider oncology management apply mathematic dna sequence translational research pharmaceutical science applied biological operational analytical nice problem solve humility bioinformatics python teamwork biology data processing collaborate translational medicine pharmacology collaboration programming innovation provider service cloud computing enthusiasm innovative data science predictive models system biology computational chemistry consulting rna machine learning testimonial english sequence analysis computational biology integrate french experience experience protein engineering
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Senior Occupational Safety and Health (OSH) Specialist

posted by: spj_bot

**This position is contingent upon contract award**

Come Join Our Team! First Division Consulting (FirstDiv) provides program management, acquisition, logistics, field service representative, explosive ordnance disposal, and personnel support services to Department of Defense and Federal Government Agencies. We are a Small Business Administration certified Service-Disabled Veteran-Owned Small Business and a Small Disadvantaged Business. If you are looking for a company who has an overall rating on Glassdoor of 4.8 and who puts their people first, then continue to read below and join the FirstDiv team!

First Division Consulting is seeking a professional to support the safety and health management needs of a large federal agency.  This position can work remotely in one of the following locations: Kentucky, Maryland, New Jersey, Ohio, and Virginia.  This position will require up to 25% travel.

Position responsibilities include:

Job Skills

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Data Manager VIVO

posted by: spj_bot

Join Excelya and Make a Difference in Clinical Research In Vivo

As part of the deployment of the new VIVO solution (Benchling application), the Data Sciences & Data Management department is seeking operational support to assist with the implementation, testing, validation, and documentation of the application.
The mission will be carried out in close collaboration with multidisciplinary teams including Data Management, Business teams, Referential teams, and the VIVO Product Team.

Key Responsibilities:

  • Support the implementation and validation of the Benchling / VIVO application
  • Perform functional testing and data consistency checks across systems (Benchling, VIVO DB, LIMS, BI tools, FederateS)
  • Validate and monitor links with referential systems (MDM and non‑MDM)
  • Support the Product Owner and Business Owner in prioritizing and implementing product enhancements
  • Execute User Story testing in an Agile environment in line with defined test plans
  • Contribute to user and functional documentation
  • Understanding of in vivo study designs, preclinical pharmacology, and toxicology data requirements. Familiarity with related laboratory information management systems (LIMS) and experimental data integration is a plus.

Requirements

Job Skills

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Biomarker Operations Lead

posted by: spj_bot

Position Overview

Excelya is seeking a highly motivated and experienced Biomarker Operations Lead to oversee and manage biomarker activities across clinical study phases. This role involves coordinating with internal teams and external partners to ensure efficient execution of biomarker strategies and operational excellence.

The Biomarker Operations Lead will provide operational biomarker expertise to ensure successful implementation and execution of the biomarker strategy across Phase I–III clinical studies. The role supports timely, high‑quality delivery of clinical biomarkers in compliance with ICH/GCP and applicable regulations.

Key Responsibilities

Job Skills

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Pharmacovigilance Associate

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

Job Skills

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