synopsis

eCTD Publishing Support (part time)

posted by: spj_bot

Rejoignez Excelya, où l'Audace, la Bienveillance et l'Énergie définissent qui nous sommes et notre manière de travailler. Nous croyons en la création de solutions audacieuses et en un environnement inclusif où la collaboration et le développement individuel vont de pair.

Vos missions

  • Mise en forme de documents au format eCTD (protocoles, rapports cliniques)
  • Gestion des marges, sauts de page, liens intra‑documents
  • Création et structuration des annexes des rapports cliniques
  • Vérification de la conformité globale des documents avant soumission
  • Transformation de documents Word en PDF (modules 2.5, 2.7.3/4, etc.)
  • Vérification et mise en conformité des documents du dossier
  • Extraction des synopsis de rapports cliniques pour le module 2.7.6
  • Dépôt des rapports cliniques dans le module 5.3
  • Recherche, vérification et chargement des références bibliographiques en module 5.4
  • Vérification finale de la conformité eCTD des PDF (liens, signets, marges)

Requirements

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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Senior Medical Monitor

posted by: spj_bot

Job Title: Senior Medical Monitor

Location: EU/Non EU

Type: Remote, Freelance

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.

Main Responsibilities:

Job Skills

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