Excelya

• 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.

Role Description We are seeking a Freelancer Senior Medical Writer, based in EU for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya’s projects. - 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. Qualifications - Degree in Life Sciences. - At least 3 years of proven experience in medical writing. - Experience with writing of protocols, CSRs and CTDs, ICFs and lay summaries. - Fluent in English. - Previous experience in CROs is a plus. - Project management and coordination skills. Benefits - High-impact projects that nurture your potential. - Opportunities to shine and push boundaries. - Becoming a key part of something bigger.

• 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.

Role Description As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements. - 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. Qualifications - Advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences, or related scientific discipline. - Strong experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician, or similar role. - Experience supporting clinical studies in Immunology & Inflammation and/or Oncology. - Strong understanding of clinical development, study design, and clinical trial conduct. - Knowledge of ICH-GCP, regulatory requirements, and clinical research processes. - Experience reviewing clinical data, patient profiles, narratives, and safety information. - Familiarity with Clinical Study Reports (CSRs), protocols, and TMF documentation. - Strong cross-functional collaboration and communication skills. - Fluent English, written and spoken. Benefits - We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. - Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. - By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. - Excelling with kindness means evolving in an environment that values ​​your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research. The **eTMF Specialist** plays a key role within the Clinical Development Platform by ensuring the **quality, compliance, and inspection readiness** of the electronic Trial Master File (eTMF) across global clinical trials. This role requires strong expertise in **clinical documentation management**, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment. **Key responsibilities :** - Led the implementation and configuration of Veeva Vault Clinical applications, including **eTMF, CTMS, Study Startup (SSU), Payments, and Site Connect**. - Facilitated requirements gathering workshops and translated business needs into scalable and compliant system solutions. - Designed and configured Vault solutions aligned with clinical operations processes and regulatory requirements. - Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation. - Oversaw data migration and system integration projects, ensuring data quality and seamless interoperability with external systems. - Developed and delivered end-user and administrator training programs, supporting user adoption and change management initiatives. - Advised stakeholders on best practices, configuration options, and alternative solutions to optimize business processes and system performance. - Partnered closely with client project teams across global pharmaceutical companies and SMEs to ensure successful project delivery and compliance with **ICH-GCP** and **GxP** standards.

Role Description The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials. This role requires strong expertise in clinical documentation management, close collaboration with cross‑functional teams, and active involvement in audits and inspections within a regulated environment. - Manage the end‑to‑end lifecycle of eTMFs, including setup, maintenance, and close‑out for clinical studies - Perform regular quality control checks to ensure document completeness, accuracy, and compliance with regulatory standards - Monitor and track TMF metrics and KPIs to ensure inspection readiness - Review and approve TMF management plans for internal teams and CROs - Act as a Subject Matter Expert (SME), providing guidance and training on eTMF best practices - Develop, update, and maintain SOPs, templates, and processes related to TMF management - Serve as the main point of contact for eTMF-related queries, audits, and inspections - Ensure compliance of the eTMF system with validation and regulatory requirements - Manage user access, system updates, and migrations, and assess the impact of new system releases - Collaborate with IT teams to resolve system issues and support continuous improvement Qualifications - Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or related field - Strong experience in clinical trial documentation management Requirements - Hands‑on experience with Veeva Vault TMF (mandatory) - Strong understanding of the DIA TMF Reference Model - Experience with TMF metrics, KPIs, and dashboards - Strong knowledge of ICH/GCP guidelines and regulatory requirements - Understanding of clinical trial documentation lifecycle - Knowledge of cross‑functional stakeholders (Clinical, QA, PV, Biometry, etc.) - Fluent English (written and spoken) Benefits At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. Here’s what makes us unique: - We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. - Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. - Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey. - Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

**Your Mission:** - 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.

Role Description We are seeking a Freelancer Senior Medical Writer, based in Colombia for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya’s projects. - 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. Qualifications - Degree in Life Sciences. - At least 3 years of experience in medical writing. - Experience with writing of protocols, CSRs and CTDs. - Fluent in English. - Previous experience in CROs is a plus. - Project management and coordination skills. Benefits - High-impact projects. - Opportunities to nurture your potential. - Space to shine and push boundaries.

• 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.

Role Description We are seeking a Freelancer Senior Medical Writer, experienced with medical devices for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya’s projects. The position is fully remote and the candidates can be based in every EU country or Armenia. - 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. Qualifications - Degree in Life Sciences. - At least 4-5 years of experience in medical writing. - Experience in medical device-related documents (CEP/CER/PMCF/PSP). - Fluent in English. - Knowledge of French language is a plus. - Submissions to FDA is a plus (for medical devices). - Regulatory consultation is a plus. Benefits - High-impact projects that nurture your potential. - Space to shine and push boundaries. - Becoming a key part of something bigger.