ph3Description /h3 pSr Project Specialist. Barcelona. Sponsor dedicated. Preferred experience with Compassionate Use programs /p pSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. /p pOur Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. /p pWhether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. /p pDiscover what your 25,000 future colleagues already know: /p h3Why Syneos Health /h3 ul liWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. /li liWe are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. /li liWe are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. /li /ul h3Job Responsibilities /h3 pSr Project Specialist. Barcelona.



Sponsor dedicated. Preferred experience with Compassionate Use programs /p h3Position Objective /h3 pProvide support for the end-to-end management of Early Access Programs, including Compassionate Use and Post-Trial Access programs, ensuring compliance with internal procedures, applicable regulatory requirements, and effective cross-functional coordination among all stakeholders involved. /p h3Key Responsibilities /h3 h3Program Operations Management /h3 ul liCoordinate the operational process for early access requests from receipt through to closure. /li liManage and maintain tracking systems, databases, and case monitoring tools, ensuring all information remains accurate and up to date. /li liMonitor timelines, milestones, and required approvals for each request. /li liEnsure proper document management and maintenance of all case-related records. /li liSupport the coordination of medication supply for active programs. /li /ul h3Cross-Functional Coordination /h3 ul liServe as the primary point of contact for operational inquiries related to early access programs. /li liCoordinate activities across Medical Affairs, Pharmacovigilance, Supply Chain, Legal, and other relevant departments. /li liFacilitate communication with healthcare professionals and participating sites regarding operational aspects of the programs. /li /ul h3Regulatory Compliance and Quality /h3 ul liEnsure all activities are conducted in accordance with applicable regulations, internal procedures, and company quality standards. /li liMaintain complete,



accurate, and audit-ready records of all activities performed. /li liSupport the preparation of audits and inspections by providing the required documentation. /li /ul h3Get to know Syneos Health /h3 pOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. /p pNo matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. /p h3Additional Information /h3 pTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. /p h3Summary /h3 pExperience managing compassionate use programs /p /p #J-18808-Ljbffr

📌 Sr Project Specialist. Barcelona. Sponsor dedicated. Preferred experience with Compassionate Us[...]
🏢 Syneos Health
📍 Barcelona