Excelya

Business Analyst

• Conduct a comprehensive analysis of document data across a complex and fragmented landscape of heterogeneous systems (EDMS platforms, SharePoint, and local repositories).
• Assess data quality, consistency, and completeness, with a specific focus on metadata standardization and reliability.
• Build a consolidated view of document inventories across systems to address the current lack of visibility.
• Identify data gaps, inconsistencies, and duplication to support remediation and harmonization efforts.
• Deliver structured insights to define the data migration scope, prioritization, and associated cost estimation.
• Support the design of the data migration strategy within the Advanced EDMS transformation program.
• Ensure alignment with GxP / GMP regulatory requirements and document management compliance standards.
• Collaborate with Global Quality stakeholders to align data analysis outputs with the broader digital transformation and EDMS consolidation objectives.

Business Analyst – Gestion Documentaire Pharma

QA Engineer

• Ensure quality management of PV deviations (RCA, CAPA, process compliance and timelines).
• Identify quality risks and implement appropriate corrective actions.
• Contribute to PV quality documentation and the annual quality plan.
• Support the Quality Management System (QMS) through monitoring of CAPAs, KPIs, deviations and changes.
• Participate in audits/inspections and ensure compliance of partners and suppliers.

Quality Assurance Officer, Pharmacovigilance

Manager

• - Ensure quality review of safety data received from partners before entry into the safety database (completeness, accuracy, compliance).
• - Oversee serious adverse event (SAE) management, including coordination and review of case narratives.
• - Perform quality checks of aggregate reports (e.g., DSURs).
• - Support PV setup for clinical studies and implementation of safety processes.
• - Manage PV documentation in eTMF to ensure inspection readiness.
• - Contribute to the setup of post-marketing PV systems.
• - Collaborate with internal teams and partners to ensure efficient and compliant safety operations.

Pharmacovigilance Manager

Clinical Operations

• Support the operational management of ongoing clinical studies.
• Contribute to study oversight and coordination activities.
• Collaborate with internal and external stakeholders, including CRO partners and study teams.
• Ensure compliance with applicable regulations, GCP and study procedures.
• Assist with workload management and operational delivery during a peak activity period.

Clinical Operations Consultant

Research Analyst

• 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.
• **Main Responsibilities:**
• - Perform monitoring of international clinical trials across Phases I–IV, ensuring protocol adherence and data integrity at investigational sites.
• - Guarantee scientific, regulatory, and technical quality through meticulous oversight and application of GCP and local regulatory standards.
• - Manage investigational product (IP) logistics including reconciliation, storage, dispensing, and inventory, with special focus on blinded/randomized protocols.
• Beyond that, you will also be able to:
• - Review and reconcile Investigator Site Files (ISF) with the Trial Master File (TMF) and ensure proper document archiving as per regulatory requirements.
• - Conduct routine monitoring and co-monitoring visits with CRAs to ensure source data verification, site performance, and resolution of deviations via CAPA processes.
• - Draft comprehensive monitoring visit reports in English and support audit readiness across all clinical sites.

Clinical Research Associate

Medical writer

• Preparation of PMCF, CER, CEP, PMS.
• Review of relevant documents.
• Consultation and gap analysis on transition from MDD to MDR.
• Responses to queries from regulatory authorities.
• Perform literature search.
• Appraise literature search data.
• Ability to interpret, evaluate, and translate medical research findings.

Senior Medical Writer, Medical Devices

Compliance

• Oversee the regulatory strategies essential for exporting cosmetics to various international markets.
• Act as the main regulatory contact for regions and partners throughout product lifecycle.
• Collaborate cross‑functionally to ensure compliant and timely submissions.
• Manage project timelines, organize export review meetings, and oversee registration tracking.
• Conduct regulatory risk assessments and propose mitigation plans.
• Monitor international regulatory developments impacting product registration and commercialization.
• Support business teams with pragmatic and compliant regulatory solutions.
• Track and monitor regulatory KPIs related to export activities.

Regulatory Affairs Export Manager – Cosmetics

Clinical Research

• Support clinical trial activities from study start-up to close-out, ensuring adherence to standards.
• Contribute to the preparation and review of trial protocols 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.
• Assist in medical writing and review of study-related documents.
• Ensure proper documentation and filing of study-related materials.
• Support preparation for audits, inspections, and regulatory submissions.