Regulatory Document Specialist, Sponsor Dedicated (Serbia)

About the role

Syneos Health is hiring a Regulatory Document Specialist, sponsor dedicated, based in Serbia. The specialist supports Regulatory and submission teams in preparing electronic regulatory submissions to health authorities worldwide, managing document deliverables and workflows to a high-quality Ready for Submission (RFS) standard.

Key responsibilities

• Independently manage assigned document packages and workflows, acting as a resource for authors and stakeholders on RFS standards, eDMS processes and tools
• Train and support users, including CRO staff, so documents follow SOPs and meet RFS requirements
• Support process improvement, gather user feedback and recommend practical improvements
• Manage binders in the eDMS for clinical and nonclinical functions, complete metadata, develop appendices, create hyperlinks and include documents in submission binders on time
• Evaluate and resolve formatting, metadata, workflow and structural issues, perform technical quality reviews and fix errors flagged by Regulatory Publishing
• Take part in team meetings, support testing of the upgraded eDMS and authoring tool, and help locate and reformat legacy documents
• Communicate the status of submitted and approved documents and share knowledge across teams
• Comply with EHS regulations, report risks and take part in mandatory EHS training

Required profile

• 2-5 years of experience as a Document Specialist in a CRO or pharmaceutical environment (pharma experience preferred)
• Bachelor's degree in Life Sciences, Medicine, Pharmacy or a related discipline; associate degree candidates considered with relevant experience
• Fluent English (C1); advanced degree is a plus
• Good time management, ability to work under pressure and to reprioritize

Required skills

• eDMS and authoring tools, ideally Veeva Vault
• Microsoft Office (Word, PowerPoint, Excel) and Adobe Acrobat
• PDF tools and hyperlinking tools such as ISI Toolbox
• Document management best practices and GCP