Sr Project Coordinator. Compassionate Use Programs. Sponsor dedicated. BarcelonaSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether 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 accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe 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.We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.General Position Summary/PurposeResponsible for supporting the planning and execution of Pre-Approval Access (PAA) Programs. Responsible to ensure requests are processed with quality, speed, compliance, and in support of company objectives.Critical thinking, excellent communication, high accountability, a global mindset, and innovative solutions to address risks and challenges are essential.Key Accountabilities/Core Job ResponsibilitiesResponsible for executing triage, tracking, delivery of product and oversight elements of Pre-Approval Access Programs in compliance with quality standards (Global Regulations and the client policies and procedures).Support development with initiating Pre-Approval Access Programs.Work cross-functionally with Clinical Drug Supply, Clinical Documentation Center, Affiliates, etc. to ensure timely and compliant drug release to support PAA program decisions.Support the Manager:o Responsible for regular updates to Manager on all assigned PAA Programs.o Responsible for regular updates to the cross-functional teams (e.g., R&D Therapeutic Areas) and stakeholders (e.g., CDSM) on number of active patients and program status.Ensures Knowledge Notebook is accurate and current.Support the development of the Rave Database for PAA Programs.Responsible for archiving PAA Program documents within VAULT.Proactively identify, resolve and/or escalate program related issues.Participate in process improvement initiatives.QualificationsWhat we're looking forBachelor's degree or equivalent is required; degree in a health-related, scientific, or preferred.At least 2 years direct experience working within the pharmaceutical industry.Demonstrated ability to work effectively in a team environment; ability to foster team productivity and cohesiveness.Strong organizational skills.Excellent attention to detail.Flexibility to adapt quickly and effectively to changing situations and priorities to ensure urgent access situations are resolved to meet patient needs.Get to know Syneos HealthOver 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.No 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.Additional Information:Tasks, 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.
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