Excelya

Role Description This freelance part-time role is an exciting opportunity to contribute to a dynamic, ambitious team in the Pharmacovigilance Department. 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. The Local Specialist Safety Officer (LSSO) involves performing as Local Contact Person responsible for Pharmacovigilance for Slovenia and participating in local/global projects within the Pharmacovigilance (PV) and Safety department. Main Responsibilities: - Collects, documents, forwards, follow-up, (where applicable) and reports appropriately and within agreed/required timelines, all case reports, complaints, queries and requests, that reach him/her or that he/she identifies. - Performs local literature search/review or quality control on results, maintain local journal/conference lists. - Acts as a local contact person for the national competent authorities regarding vigilance issues (or the back-up contact person). - Maintains required level of understanding of the regional/national vigilance legislation. - Participates in audits/inspections. - Collects and assesses safety information and regulatory intelligence at the local (national) level, ensuring compliance with the applicable local regulations and requirements, and acts as a point of contact for the local Regulatory Authorities with regards to PV and other product safety as applicable. Qualifications - Minimum of 1 year of experience in Pharmacovigilance. - Meeting the local/national requirements for performing as local responsible/contact/qualified person in pharmacovigilance. - Life-science graduate or relevant degree, or an equivalent combination of experience and education. - Fluency in English and Slovenian language. Benefits - Opportunity to work in a young, ambitious health company. - Access to diverse projects and collaboration with preeminent experts. - Environment that values natural talents and nurtures potential. - Commitment to equal opportunities and fostering a diverse, equitable, and inclusive workplace. Company Description At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. We are driven to become Europe’s leading mid-size CRO with the best employee experience. 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 challenges become our shared mission. Together, we transform bold ideas into reality—the Excelya way.

• Design, develop, and manage clinical learning and development programs that align with organizational goals and industry best practices. • Collaborate with cross-functional teams to identify learning needs and translate them into effective training solutions. • Oversee the creation of training materials, e-learning modules, and workshops to enhance clinical team competencies. • Coordinate the scheduling, delivery, and tracking of learning initiatives to ensure maximum engagement and completion. • Evaluate the effectiveness of training programs through feedback, assessments, and performance metrics, and implement continuous improvements. • Manage learning and development projects ensuring timely delivery within budget and scope. • Promote a learning culture within clinical teams, fostering continuous professional development. • Stay updated on the latest trends and innovations in clinical training and development.

Role Description Excelya is seeking a Clinical Learning Development Project Manager to join our innovative and dynamic team. In this role, you will be responsible for managing and delivering learning and development initiatives tailored to clinical operations and research teams. You will ensure that training programs are designed, implemented, and evaluated to enhance team performance and support professional growth in line with company values of Audacity, Care, and Energy. - Design, develop, and manage clinical learning and development programs that align with organizational goals and industry best practices. - Collaborate with cross-functional teams to identify learning needs and translate them into effective training solutions. - Oversee the creation of training materials, e-learning modules, and workshops to enhance clinical team competencies. - Coordinate the scheduling, delivery, and tracking of learning initiatives to ensure maximum engagement and completion. - Evaluate the effectiveness of training programs through feedback, assessments, and performance metrics, and implement continuous improvements. - Manage learning and development projects ensuring timely delivery within budget and scope. - Promote a learning culture within clinical teams, fostering continuous professional development. - Stay updated on the latest trends and innovations in clinical training and development. Qualifications - Proven experience in managing learning and development projects, preferably within clinical research or pharmaceutical environments. - Strong knowledge of adult learning principles and instructional design methodologies. - Excellent project management skills with the ability to handle multiple initiatives simultaneously. - Strong communication and interpersonal skills with the ability to collaborate effectively across teams. - Proficiency with learning management systems (LMS), e-learning platforms, and digital training tools. - Degree in Life Sciences, Education, Human Resources, or related field. - Fluency in English and French is required. Benefits - At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. - 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.

• Focus on drafting patient-facing clinical documents in lay language : • Drafting and revising (as needed): Lay summaries of Clinical Study Reports (CSR lay summaries), Protocol synopsis in lay language (Plain Language Protocol Synopsis) • Coordination of : authoring activities, document planning, review cycles with stakeholders • Maintaining scientific accuracy • Meeting EU CTR / CTIS plain-language expectations • Coordinating multi-stakeholder reviews within timelines • Ensuring robust quality control and version management • Content planning and outline proposal • Drafting from : CSR / protocol, supporting materials • Incorporation of review comments • Version management • Final document preparation • Contribution to : terminology consistency, glossary, readability

• Develop, write, and edit a wide range of scientific and medical documents, ensuring accuracy, clarity, and compliance with regulatory and journal requirements. • Produce materials such as manuscripts, abstracts, posters, slide decks, and other scientific communications. • Prepare and review patient‑facing documents, including: Informed Consent Forms (FR/ENG), Non‑opposition letters (FR/ENG), Lay summaries • Write and contribute to clinical and regulatory documents, including: Clinical study protocols (Phase I–III), Clinical Study Reports (CSRs), Common Technical Document sections (CTD 2.4–2.7) • Support medical affairs activities such as: Review of promotional and non‑promotional materials, Medical training for internal and external stakeholders, Medical information services • Collaborate with cross‑functional teams, subject matter experts, and clients to ensure scientific accuracy and alignment with project objectives.

Role Description We are seeking a Freelancer Senior Medical Writer, French speaker for a part-time role, to provide medical and scientific expertise required for the successful completion of Excelya’s projects. The candidate can be based everywhere in EU. Your Mission: - Develop, write, and edit a wide range of scientific and medical documents, ensuring accuracy, clarity, and compliance with regulatory and journal requirements. - Produce materials such as manuscripts, abstracts, posters, slide decks, and other scientific communications. - Prepare and review patient‑facing documents, including: - Informed Consent Forms (FR/ENG) - Non‑opposition letters (FR/ENG) - Lay summaries - Write and contribute to clinical and regulatory documents, including: - Clinical study protocols (Phase I–III) - Clinical Study Reports (CSRs) - Common Technical Document sections (CTD 2.4–2.7) - Support medical affairs activities such as: - Review of promotional and non‑promotional materials - Medical training for internal and external stakeholders - Medical information services - Collaborate with cross‑functional teams, subject matter experts, and clients to ensure scientific accuracy and alignment with project objectives. Qualifications - Degree in Life Sciences. - Previous working experience in the pharmaceutical/health industry. - Experience in writing: ICF (FR/ENG), non-opposition letters (FR/ENG), lay summaries, posters/manuscripts, protocols (Phase I-III), CSR, CTDs (2.4-2.7). - Experience in medical device-related documents would be considered a plus (CEP/CER/PMCF/PSP). - Able to work autonomously. - Experience in clinical documents for interventional and non-interventional studies. - Critically evaluate scientific data. - Project management skills. - Able to review TFLs and participate in data review meetings. - Fluent in English and French language. Benefits At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient’s journey. Here, you're not just doing a job—you’re becoming a key part of something bigger.

Redefine Pharmacovigilance. Empower Innovation. Build with Audacity. Join Excelya as Our Next PV Star! At Excelya, we don’t just work, we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience. Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Pharmacovigilance. Ready to make an impact that travels the globe? Let’s talk.   About the Job We are seeking a Pharmacovigilance Specialist who will be assigned to specific responsibilities for the handling of product safety (e.g. pharmacovigilance, device or cosmeto- vigilance) or other issues for a Client of Excelya PV & Safety. Will perform in compliance with the client’s and/or EXCELYA’s SOPs and where applicable as per client’s job description.   Your Mission: - Supporting the Nominated contact person for pharmacovigilance (Local QPPV equivalent) as notified to the local Health Authorities. - Implement and maintain a compliant pharmacovigilance system for products authorized in the territory. - Collaborate with corporate Patient Safety teams. - Maintain local pharmacovigilance quality systems and SOPs. - Maintain up-to-date knowledge of local pharmacovigilance regulations.

• Reporting to the Registration Department Team Manager, you are responsible for all activities related to the obtention, follow-up and maintenance of Marketing Authorizations (MA) in France and Europe, including: • Submission and follow-up of Marketing Authorization applications at both national and European levels. • Preparation, submission and follow-up of regulatory evaluations with Competent Authorities for: pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), regulatory variations, up to their practical implementation. • Monitoring product registration in the Generic Groups Directory. • Acting as an interface with internal departments, external experts, API manufacturers and contract manufacturing organizations (CMOs).

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 Regulatory affairs department. 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. Responsibilities : Reporting to the Registration Department Team Manager, you are responsible for all activities related to the obtention, follow-up and maintenance of Marketing Authorizations (MA) in France and Europe, including: - Submission and follow-up of Marketing Authorization applications at both national and European levels. - Preparation, submission and follow-up of regulatory evaluations with Competent Authorities for: pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), regulatory variations, up to their practical implementation. - Monitoring product registration in the Generic Groups Directory. - Acting as an interface with internal departments, external experts, API manufacturers and contract manufacturing organizations (CMOs).

**Your Mission:** - Lead the preparation and review of key medical device documentation, including **PMCF** plans/reports, **PSURs**, **CERs**, and **PMS** reports for class IIA, IIB and III medical devices. - Conduct comprehensive literature searches and critically appraise scientific data to support regulatory and clinical documentation. - Provide expert medical and scientific input across projects, ensuring compliance with **MDR** requirements and supporting transitions **from MDD to MDR**. - Respond to regulatory authority queries with clear, evidence‑based medical justifications. - Collaborate with cross‑functional teams to support study‑related documentation (protocols, study reports) for **medical device projects**. - Participate in scientific meetings and stay updated on clinical and **regulatory developments in the medical device field**.