Project Specialist – Regulated Activities, Early Access Treatments

Syneos Health

Project Specialist providing operational project management support for Early Access Treatments projects at Syneos Health. Ensuring compliance, driving timelines, and resolving operational challenges.

Posted 7/28/2026full-timeRemote • 🇪🇸 SpainMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in operational project management for Early Access Treatments, ensuring compliance with internal SOPs and facilitating effective communication among cross-functional stakeholders. Proficient in coordinating project deliverables, tracking documentation, and supporting continuous improvement initiatives.

Highest-signal resume keywords

Operational Project ManagementCompliance with SOPsCross-Functional CoordinationDocumentation AdministrationRisk Identification and Resolution

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Project ManagementDocumentation TrackingOperational Risk ManagementContinuous ImprovementDatabase Maintenance

Soft Skills

Effective CommunicationTeam CollaborationProblem Solving

Industry Keywords

Early Access TreatmentsRegulated ActivitiesAudit ReadyStakeholder Engagement

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.