About Ouissem
Medical expert in clinical trial regulations with strong experience in project management, communication, and problem-solving. I have particular expertise in Phase I, II, and III trials, EU CTR (Part I&2) as well as in oncology. I have worked internationally and am capable of managing clinical trials from A to Z, while respecting budgets and deadlines. My communication skills allow me to present complex information clearly and concisely, and I am recognized for my ability to solve problems quickly and efficiently.
English
Native or bilingual
French
Native or bilingual
Remote only
Primarily works remotely
Experience
- HeaDS,Regulatory Project ManagerPHARMACEUTICALS INDUSTRYJanuary 2025 - Today (1 year and 5 months)• Partners with Project Managers and Regulatory Submission Managers to create integrated and dynamic operational regulatory submission plans.• Conducts scenario planning, considering all submission activities and required resources.• Creates visuals and reports to raise awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.• Anticipates delays and mitigates their impact on timelines.• Ensures submission teams are aware of upcoming deliverables, aligned on roles and responsibilities, understand interdependencies, and meet target submission dates.• Leads submission planning discussions, including setting agendas, taking minutes, and following up on key actions with stakeholders.• Collaborates with cross-functional teams to identify ways to optimize and accelerate submission timelines.• Manages vendors, ensuring service delivery.
- HeaDS,Regulatory Submission ManagerPHARMACEUTICALS INDUSTRYJanuary 2023 - January 2024 (1 year)• Managed trials from a regulatory perspective by providing input into master documents (trial protocol, Master ICFs) and leading meetings on regulatory strategies and timelines.
- Syneos Health Clinical Solutions,Site Start-Up & Regulatory Specialist IIPHARMACEUTICALS INDUSTRYJanuary 2022 - January 2023 (1 year)France• Pioneered regulatory submissions under EU CTR.• Ensured high-quality regulatory deliverables for France, adhering to project requirements and local regulations.
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Education
- Medical DoctorFaculty of Medicine2014Medical Doctor
- CRASupSante2019CRA