Project Specialist – Regulated Activities, Early Access Treatments

🔥 2 hours ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Monitor deliverables and follow up on outstanding actions to maintain project momentum. • Identify, escalate, and help resolve operational risks, issues, and bottlenecks. • Ensure compliance with internal SOPs and study processes and requirements. • Guide teams through required approvals, reviews, and process steps. • Support continuous improvement initiatives.

🎯 Requirements

• The Regulated Activities Scientific Project Specialist provides operational project management support for Early Access Treatments projects. • Acting as the right hand of the Project Lead, responsible for ensuring OOS or CUPs progress efficiently through all required processes and requirements while maintaining compliance, driving timelines, and resolving operational challenges. • 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.

🏖️ Benefits

• 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.