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Senior Medical Writer

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 Medical Affairs. 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.

The Medical Writer is in charge of producing medical writing deliverables (both regulatory and medical communication documents).

The Medical Writer will draft the reference documents for clinical studies, other research involving the human person and research not involving the human person and which must be part of the authorization request file from the Competent Authorities, such as the protocol, the summary of the protocol, the information and consent form, the observation booklet and any patient questionnaires and the investigator brochure.

The Medical Writer will work alongside healthcare professionals, project managers, statisticians and other company functional groups to produce the medical writing deliverables.

Main Responsibilities:

 

Job Skills

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Scientifique PKPD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

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Pharmacien(ne) Pharmacovigilance

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:

  • Supervise pharmacovigilance case management outsourced to assigned platform(s)
  • Respond to case-related emails and inquiries from external service providers
  • Monitor case processing timelines and investigate any delays in reporting or transmission
  • Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
  • Support the review and validation of clinical study case narratives for inclusion in study reports
  • Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
  • Oversee reconciliation of cases with clinical databases managed by outsourced providers
  • Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

Job Skills

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Medical Advisor (MDA)

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 Regulatory. 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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Scientifique PK/PD

posted by: spj_bot

About the Job

Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.

Key Responsibilities:

Job Skills

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Pharmacokineticist

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We are committed to creating innovative solutions and fostering a collaborative and inclusive work environment.

The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials, ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation. This role involves close collaboration with clinical, non-clinical, and modeling teams to deliver robust pharmacokinetic data and modeling outputs that inform drug dosing strategies and regulatory submissions.

Main responsibilities:

Job Skills

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Clinical Operation Lead

posted by: spj_bot

About the Job

At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.

The Clinical Monitoring Lead will oversee and coordinate clinical monitoring activities to ensure the successful and compliant execution of clinical trials. This role involves leading CRA teams, ensuring quality standards are met, and maintaining effective communication with stakeholders to implement best clinical practices.

Main Responsibilities

Job Skills

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Clinical Research Director - Immunology

posted by: spj_bot

About the Job

Excelya is seeking a Clinical Research Director (CRD) in Immunology, a physician‑scientist responsible for providing medical leadership and scientific oversight across clinical development programs in immunology.

The Clinical Research Director acts as the medical reference for assigned clinical trials, ensuring scientific quality, patient safety, regulatory compliance, and cross‑functional alignment throughout the clinical development lifecycle.

Main Responsibilities:

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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Clinical Research Coordinator

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.

A company specialized in infant nutrition is currently conducting several Phase III clinical studies evaluating the efficacy and tolerability of formulations based on natural ingredients.

To support this growing clinical activity, the organization is seeking an Clinical Research Associate capable of coordinating clinical studies and ensuring strict operational and regulatory compliance.

Main Responsibilities

1. Study Documentation & Preparation

    • Contribute to writing the study synopsis, protocol, and all study‑related documents (CRF, patient information sheet, informed consent form, safety reports, clinical reports).
    • Prepare and supervise regulatory submissions to competent authorities (ANSM, CPP, CNOM, and international equivalents).

2. Clinical Study Conduct

Job Skills

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