Excelya

Clinical Operations

• Coordinate feasibility assessments and interactions with investigators, experts, and key stakeholders.
• Lead the preparation, start‑up, implementation, and operational oversight of clinical trials.
• Support regulatory submissions and study maintenance activities through **CTIS**.
• Review and oversee country‑specific study documentation to ensure regulatory compliance.
• Monitor study KPIs, metrics, and dashboards to track study performance.
• Coordinate external monitoring providers and administrative support vendors.
• Organize and lead study meetings, ensuring appropriate documentation and follow‑up of action items.
• Monitor patient recruitment, site engagement, and overall study progress.
• Identify study risks and implement mitigation plans to ensure successful delivery.
• Manage study budgets and track financial performance.
• Provide support to investigational sites through on‑site visits when required.
• Oversee study close‑out activities, including site closure, database lock, and study archiving.

Clinical Project Manager

Medical writer

• To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation.
• To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs).
• To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality.
• To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines).
• To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers.
• To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.

Senior Medical Writer – Europe

Content Writer

• To perform quality control activities, ensuring the accuracy of all information, data, and references for the documents/tables/figures/listings produced, also reviewing spelling, grammar, appropriateness of language, correct mention of links to other parts of the document or other documents, and compliance with industry guidelines.
• To check information in the document against the data source (internal consistency within a document and across documents).
• To deliver documented quality review comments or checklists to the document’s author through resolution, while interacting with the Medical Writers and other team members to resolve QC findings.
• To liaise with internal groups such as Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical, and Quality Assurance to gather necessary information.
• To ensure timely completion of quality control activities and keep the Medical Writer (MW) informed of document status in relation to quality and timelines.
• To maintain familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing and quality control.

Quality Control Specialist – Medical Writing

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) by monitoring CAPAs, KPI, deviations and changes.
• Participate in audits/inspections and ensure compliance of partners and vendors.

Pharmacovigilance, Quality Assurance Officer

• Lead and coordinate global study teams to ensure the successful delivery of clinical trials.
• Develop and manage study plans, timelines, budgets, resources, risks, and mitigation strategies.
• Select, manage, and oversee CROs and third-party vendors, including participation in RFP processes and vendor selection.
• Drive study execution from protocol development through study close-out and archiving.
• Identify risks, implement corrective actions, and ensure compliance with quality standards and ICH-GCP requirements.
• Review and contribute to key clinical study documents.
• Facilitate study team meetings and ensure follow-up of actions and decisions.
• Collaborate with cross-functional stakeholders to ensure efficient study conduct and patient recruitment strategies.
• Ensure inspection readiness and support audits and regulatory inspections.
• Maintain oversight of Trial Master File (TMF) completeness and study documentation quality.

Global Clinical Project Manager

Digital Marketing

• 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.
• **Main Responsibilities:**
• - Assess consumer engagement, digital marketing, omnichannel, content, data, and measurement maturity to identify capability gaps and opportunities.
• - Define a consumer engagement strategy by prioritizing target audiences, journeys, and high-impact activation opportunities.
• - Integrate SEO, GEO, and AI/LLM discoverability into content, channel, and activation strategies.
• - Design consumer journey blueprints and translate them into actionable roadmaps and campaigns.
• - Lead the implementation roadmap, including governance, milestones, KPIs, dependencies, and decision-making processes.
• - Develop and launch a consumer strategy pilot, measuring performance and driving optimization.
• - Collaborate cross-functionally with Marketing, Communications, Medical, Sales, and agencies to ensure effective and compliant execution.
• - Ensure pharmaceutical compliance and ethical standards while upskilling marketing teams through training and best-practice sharing.

Senior Consumer Engagement, Digital Marketing Consultant

Manager

• Lead the integration of the Quality Management System (QMS), including documentation and training activities related to the transfer of operations.
• Define and manage documentation scopes associated with transferred activities.
• Support teams in the drafting, review, and continuous improvement of quality documents, including SOPs, procedures, and forms.
• Ensure harmonization of documentation practices across impacted sites.
• Coordinate documentation activities and monitor project timelines to ensure successful delivery.
• Track action plans, identify risks and bottlenecks, and implement mitigation actions to maintain project milestones.
• Manage training activities from needs identification through content development, delivery, and effectiveness assessment.
• Support change management initiatives by facilitating adoption of new processes and addressing resistance to change.
• Coordinate quality events linked to the project, including Change Controls, CAPAs, and deviations.
• Develop and monitor project KPIs and maintain quality trackers to ensure project visibility and compliance.

Quality Manager

Artificial Intelligence

• Réaliser un état des lieux du dispositif actuel de veille réglementaire.
• Identifier et analyser les sources réglementaires stratégiques (EMA, CMDh, ANSM, HMA, autorités nationales, publications et lignes directrices réglementaires, etc.).
• Recueillir et formaliser les besoins des équipes Affaires Réglementaires.
• Évaluer les axes d’optimisation et les opportunités d’automatisation des processus existants.
• Elaborer une stratégie de veille réglementaire alignée sur les enjeux et activités
• Concevoir un modèle de qualification et de priorisation des informations réglementaires.
• Analyser les impacts des évolutions réglementaires sur les activités et produits de l’entreprise.
• Développer une méthodologie de contextualisation des informations réglementaires en fonction du portefeuille produits et des marchés concernés.
• Identifier et évaluer les cas d’usage de l’intelligence artificielle applicables aux Affaires Réglementaires.
• Contribuer à l’analyse et à la sélection des solutions technologiques disponibles sur le marché.
• Évaluer de manière critique les outils, technologies et approches innovantes proposés.
• Définir les modalités d’intégration de l’IA au sein des processus et pratiques réglementaires.

Senior Regulatory Intelligence, AI

General

• Define and oversee the Quality Management System (QMS) for Commercial Operations in collaboration with GxP-related functions (Medical Affairs, Pharmacovigilance, Regulatory Affairs, Supply Chain, etc.)
• Act as the Commercial Operations representative in the development and maintenance of global quality standards, procedures, and Quality Technical Agreements (QTAs)
• Lead the deployment, harmonization, and continuous improvement of QMS processes across global and local organizations, affiliates, and business units
• Manage quality documentation processes and support process owners, authors, and users through document review systems and training initiatives
• Ensure ongoing GxP compliance, identify gaps, and drive remediation plans, corrective actions, and preventive actions (CAPAs)
• Support audit and inspection readiness activities, coordinate responses, and ensure effective follow-up of inspection and audit findings
• Promote a strong quality and risk management culture, maintaining risk registers and driving continuous improvement initiatives
• Develop and oversee GxP training programs and Quality Management Reviews to ensure organizational competence and compliance
• Coordinate with sites, functions, and partners to resolve quality issues, manage deviations and changes, and support crisis prevention and management activities
• Oversee quality activities involving external partners, including supplier oversight, product complaint management, QTA negotiation and management, and timely communication of APQRs to MAHs

Global Quality Systems Coordinator

Research Analyst

• Conduct site initiation visits, monitoring visits, and close-out visits.
• Ensure site compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
• Communicate effectively with study sites to facilitate the trial process and address any issues that arise.
• Review and verify study-related documents and data for accuracy and completeness.
• Monitor patient safety and data integrity throughout the study.
• Assist in preparing for audits and regulatory inspections.
• Provide regular updates to project managers and stakeholders about site progress and challenges.

Clinical Research Associate – Oncology

Clinical Research

• Support and represent the Study Medical Manager throughout the clinical study lifecycle.
• Contribute to the development and review of key clinical documents, including 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 closely with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams to support data review and consistency checks.
• Review study-related documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs.
• Support the 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

Associate

• - Ensure compliance with pharmacovigilance regulations, company procedures, and quality standards.
• - Manage Individual Case Safety Reports (ICSRs) in accordance with local legislation and internal guidelines.
• - Communicate relevant safety information to health authorities, stakeholders, and external partners.
• - Support safety surveillance activities, including risk management, safety issues, and product-related alerts.
• - Contribute to the creation and maintenance of quality documents and ensure proper documentation practices.
• - Deliver training on pharmacovigilance processes to internal employees.
• - Collaborate with third parties involved in pharmacovigilance activities.
• - Promote adherence to corporate policies, values, and compliance standards, including HSE requirements.

Pharmacovigilance Associate

• **Main Responsibilities: **
• - *To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation.*
• - *To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs).*
• - *To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality.*
• - *To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines).*
• - *To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers.*
• - *To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.*
• - *To acknowledge and strictly comply with sponsors’ and Excelya’s SOPs, guidelines and appropriate local and international legislation. To keep himself/herself continuously informed on any amendments or updates of the above-mentioned guidelines, applicable laws and procedure*
• - *To perform a literature review according to the project’s requirements for its effective completion and according to the sponsors’ and Excelya’s SOPs*
• - *To review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency*
• - *To maintain familiarity with current industry practices and regulatory requirements, and guidelines that affect medical writing*
• - *To assist with any other project or other teams (Medical Advisor, Medical Monitor) of the Medical Affairs Department as requested by the superior*
• - *To support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers*
• - *To act as a backup to other Senior Medical Writers and Medical Writers when needed*

Senior Medical Writer

• 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.
• **Main Responsibilities:**
• - Create, edit and publish high-quality content across various channels (internal platforms, websites, social media, newsletters), ensuring clarity, relevance and alignment with communication objectives.
• - Contribute to both corporate and project-related communications, ensuring consistency of messaging across audiences including employees, customers and external stakeholders.
• - Design simple yet effective communication plans, identifying key messages, target audiences, appropriate channels and timelines.
• - Choose the right mix of digital and traditional channels based on objectives and audience insights, and optimize usage for maximum reach and engagement.
• - Establish basic KPIs (e.g. engagement rates, reach, click-throughs) and monitor performance to continuously improve communication effectiveness.
• - Assist in the preparation and execution of press, customer or internal events, including content development, logistics coordination and follow-up activities.
• - Guarantee that all communication materials adhere to corporate branding guidelines and regulatory requirements, particularly in a pharma or regulated environment.
• - Take ownership of operational tasks such as content calendars, project follow-ups, stakeholder alignment and coordination, ensuring smooth execution and relieving senior team members.

Communication Manager

• Provide administrative and operational support to clinical study teams across all study phases
• Manage and maintain Trial Master File (TMF/eTMF), ensuring completeness, accuracy, and compliance
• Prepare, collect, and track essential study documents (protocols, investigator files, regulatory documents)
• Support site start‑up activities, including document collection and regulatory submissions
• Coordinate communication between internal teams, CROs, and investigational sites
• Track study progress, timelines, and deliverables, ensuring deadlines are met
• Organize and support investigator meetings, study meetings, and training sessions
• Assist with vendor and CRO coordination when required
• Ensure documentation is inspection-ready and aligned with regulatory standards
• Support audits and inspections by providing required documentation