Excelya

General

• Provide functional support and administration for analytical platforms, primarily SAS (Viya, Grid, Clinical) and related systems
• Act as the main interface between Biostatisticians, SAS Programmers, IT teams, QA, and external providers
• Manage incidents, track technical issues, and coordinate resolution activities
• Ensure compliance and maintain Computer System Validation (CSV) documentation
• Develop and maintain quality documentation in accordance with GxP requirements
• Deliver training and support to end users
• Participate in system upgrades, deployments, and validation activities
• Monitor platform usage and propose corrective and preventive actions when needed
• Support the assessment and framing of new system implementation projects

Clinical Analytics Platform Lead – SAS, Cloud

Data Management

• Provide functional support and administration for clinical data systems, primarily Oracle DMW and Oracle TMS
• Act as the main liaison between business users, IT teams, QA, and vendors
• Manage incidents, track system issues, and support resolution activities
• Ensure system validation activities and maintain compliant CSV documentation
• Develop and maintain quality documentation in accordance with GxP requirements
• Train and support end users on system functionalities and best practices
• Participate in system upgrades, deployments, and validation activities
• Monitor system usage, identify improvement opportunities, and support CAPA implementation
• Contribute to the scoping and assessment of new system implementation projects

Business System Expert – Data Management Workbench

Clinical Research

• Enter clinical data into electronic case report forms (eCRFs)
• Manage and resolve queries with investigator sites and project teams
• Review source documents to ensure data quality, consistency, and completeness
• Prepare for and support monitoring visits by ensuring the availability and organization of the required documentation
• Provide operational follow-up for investigator sites and contribute to the smooth execution of clinical studies
• Travel regularly throughout France to support sites, assist local teams, and ensure the quality of collected data
• Participate in coordinating clinical research activities with medical teams, investigators, and the various study stakeholders
• Ensure compliance with Good Clinical Practice (GCP) and applicable procedures throughout the study

Clinical Research Associate – Investigator Site

• Support the administration, maintenance, and continuous improvement of the Veeva Vault eTMF platform
• Serve as a functional point of contact for eTMF and Clinical Operations stakeholders
• Gather, analyze, and translate business requirements into functional specifications and user stories
• Support system enhancements, releases, and implementation of new functionalities
• Prepare and execute testing activities, including User Acceptance Testing (UAT), and manage issue resolution
• Contribute to Computerized System Validation (CSV), change control, and GxP compliance activities
• Provide user support and training
• Collaborate with Clinical Operations, Quality, IT, and global teams

eTMF Functional & Systems Specialist

Compliance

• Lead the global Regulatory CMC strategy for a small molecule product
• Support Marketing Authorization Applications
• Lead and review Module 3 preparation and submission activities
• Support interactions with FDA, EMA and other Health Authorities, including responses to questions
• Identify regulatory risks and define mitigation strategies
• Operate within a global and cross-functional matrix environment
• Align CMC regulatory strategies with development and commercialization objectives
• Coordinate with CMC, Quality, Manufacturing, Regulatory and Technical teams
• Ensure consistency, scientific robustness and regulatory compliance of submission content
• Provide strategic input on regulatory positioning and negotiation approaches
• Ensure compliance with applicable ICH and global regulatory requirements

Senior Regulatory CMC Consultant

Clinical Operations

• Support initiative sponsors during the Opportunity and Feasibility phases before project implementation
• Clarify business needs, objectives, and expected value of new initiatives
• Identify and map impacted business processes, systems, and stakeholders
• Lead workshops with Business, IT, and senior stakeholders
• Assess project feasibility, risks, dependencies, and key success factors
• Define required resources, budget estimates, and governance
• Develop high-level project roadmaps and recommendations
• Deliver structured project framing and feasibility documentation to support decision-making

Project Manager, Clinical Systems

Software Engineer

• Provide Oracle Programming input for Data Management activities dedicated to one Sponsor
• Ensure all clinical programming aspects comply with Client SOPs and are delivered to high quality
• Work closely with different study stakeholders internally
• Program using Oracle tools including DMW and LSH
• Apply SDTM and generate datasets according to DMW specifications
• Set up external data vendor integrations from DMW specifications
• Perform transformation mapping according to specifications
• Manage external data loading and integrations in DMW
• Perform VC/PD programming in DMW

Oracle Programmer

• Support and represent the Study Medical Manager throughout the clinical study lifecycle
• Contribute to the development and review of protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans
• Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases
• Collaborate with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams on data review and consistency checks
• Review study documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs
• Support preparation and management of study committees, investigator meetings, and study training activities
• Maintain medical and scientific documentation within the Trial Master File (TMF)
• Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams
• Develop medical review guidelines and support outsourced medical review activities when applicable
• Contribute to audit and inspection readiness activities and support responses to findings

Clinical Scientist – Immunology

• Lead the global CMC Regulatory strategy for one small molecule asset in late phase, with MAA under preparation
• Define, develop, own, and execute the global CMC Regulatory strategy while maximizing regulatory outcomes
• Ensure CMC Regulatory strategies enable potential accelerated product development pathways and speed product delivery to patients
• Manage projects to ensure high-quality and timely delivery of regulatory documents
• Lead the CMC strategy for agency interactions, including preparation of the BB
• Represent CMC Regulatory in asset cross-functional technical, regulatory, and governance meetings as needed
• Provide CMC Regulatory support to the Regulatory CMC technical writing team regarding country requirements
• Liaise with local affiliates to develop efficient regulatory strategies for delivering the CMC Dossier according to country requirements and agreed timelines
• Generate gap analyses and provide risk management support for submissions in core markets
• Compile regulatory documents for submissions in core markets on time and according to country requirements

Senior Regulatory CMC Project Lead

Business Operations

• Lead and optimize global regulatory processes to ensure their efficiency, compliance, and harmonization internationally
• Ensure functional governance of the RIM system and alignment between business needs and digital solutions
• Support users, provide functional assistance, and resolve day-to-day issues
• Coordinate change management activities related to process, tool, and organizational developments
• Gather, analyze, and prioritize business needs with Regulatory Affairs, Quality, IT, and international stakeholders
• Oversee the lifecycle of enhancement requests: tickets, functional specifications, user acceptance testing, deployment, and post-implementation follow-up
• Participate in data migration projects and ensure the integrity, quality, and consistency of regulatory data
• Monitor performance indicators and propose continuous improvement initiatives
• Act as the liaison between business and IT teams
• Contribute to Regulatory Affairs digital transformation projects, particularly those involving Veeva Vault RIM
• Develop and maintain procedures, user guides, and training materials
• Ensure the adoption of best practices and process compliance

Business Process Manager – Regulatory Affairs

QA Engineer

• Ensure rigorous, compliant, and well-documented execution of Design Verification & Validation activities, from plans and protocols through final reports.
• Define, draft, review, and approve quality documentation associated with V&V activities.
• Ensure traceability between requirements, tests, results, and acceptance criteria.
• Contribute to product risk management in accordance with ISO 14971.
• Ensure compliance with ISO 13485, the MDR, FDA 21 CFR Part 820, and internal procedures.
• Participate in internal and external audits as the Quality subject-matter expert for V&V and Design Control.
• Contribute to the continuous improvement of Quality processes, methods, and tools.
• Provide technical supervision to an experienced engineer and support project and R&D teams on quality requirements and V&V best practices.
• Participate in the management of nonconformities and CAPAs related to V&V activities.

Quality Engineer – Design Control, V&V

• Provide operational regulatory support to a pharmaceutical affiliate in Greece
• Maintain and manage the lifecycle of national Marketing Authorisations, particularly for an oncology product
• Support regulatory activities across several European distributor markets
• Manage Marketing Authorisation lifecycle and ensure regulatory compliance
• Prepare, submit, and track regulatory variations, renewals, and post-approval changes
• Support new Marketing Authorisation applications when required
• Review and maintain product information and regulatory documentation
• Approve local translations, labelling, packaging, and artwork materials
• Coordinate regulatory activities with affiliates, distributor markets, and global teams
• Partner with cross-functional teams and support Quality/GDP activities when needed

Regulatory Affairs Specialist

IT Support

• Contribute to the qualification, commissioning, and operational start-up of a new antigen production site
• Lead or support automation projects for new installations, revamping, and technical upgrades
• Ensure compliance with internal and regulatory standards
• Diagnose, troubleshoot, and resolve issues related to automated production systems and industrial utilities
• Define automation architectures and solutions with suppliers and internal stakeholders
• Ensure the performance, reliability, and evolution of automated systems
• Manage maintenance plans, technical improvements, and related documentation
• Contribute to the Industry 4.0 strategy and the digitalization of workshops and industrial equipment
• Ensure the security, integrity, and transfer of industrial data
• Provide technical expertise to internal teams and promote best practices in safety, quality, and performance
• Participate in the qualification and validation of automated systems

Automation and Industrial IT Engineer

• Ensure regulatory, ICH-GCP, and protocol compliance
• Evaluate site and staff performance, recommend site-specific actions, escalate key issues, and develop action plans
• Maintain current knowledge of ICH-GCP, regulations, and company SOPs/processes
• Check site and external facilities, equipment, and supplies for adequate trial conduct and expiry dates
• Conduct source document review and verification of site source documents and medical records
• Manage reporting and follow-up of protocol deviations
• Enter observations, status updates, and action items into tracking systems through resolution
• Follow up on escalated adverse event monitoring report queries
• Conduct on-site and remote monitoring activities where permitted by country regulations and the monitoring plan
• Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
• Work closely with the Site Manager, investigators, institutions, and other team members
• Ensure sites follow the study plan and remain ready for inspections