Project Specialist - FSP - Regulated Activities Early Access Treatments PS

Syneos 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.
 
Our 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.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We 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 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. 
• We 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. 

Job Responsibilities

The Regulated Activities Scientific Project Specialist (PS) provides operational project management support for Early Access Treatments projects which includes but are not limited to individual requests for a medicine in compassionate use (Out Of Scope requests - OOS), or a cohort program for early access to a specific medication (Compassionate Use Program - CUP). Acting as the right hand of the Project Lead, the PS is responsible for ensuring OOS or CUPs progress efficiently through all required processes and requirements while maintaining compliance, driving timelines, and resolving operational challenges.
This role serves as the operational and process expert, enabling successful project execution through proactive coordination, project tracking and stakeholder alignment.

The PS ensures that projects are executed on time, in compliance, and with operational excellence, allowing the Project Lead to focus on scientific leadership, strategic decisions, and stakeholder management.

• Manage monitor and track project progress against project plans, timelines, and key milestones.
• Ensure compliance with internal SOPs and study processes and requirements.
• Guide teams through required approvals, reviews, and process steps.
• Monitor deliverables and follow up on outstanding actions to maintain project momentum.
• Identify, escalate, and help resolve operational risks, issues, and bottlenecks. Support continuous improvement initiatives.
• Coordinate cross-functional stakeholders and facilitate effective communication.
• Organize, prepare, and support project meetings and alignment sessions.
• Support preparation, routing, tracking, and administration of study documentation, ensuring is complete, compliant, and audit ready.
• Maintain databases and systems with accurate and up-to-date information.

Get to know Syneos Health

Over 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.

http://www.syneoshealth.com

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.