# Regulatory Document Specialist, Sponsor Dedicated

**Company**: Syneos Health
**Location**: Belgrade
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/SRB-Belgrade/Regulatory-Document-Specialist--Sponsor-Dedicated--based-in-Serbia_25113896?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f46ca565-593

## Description

Syneos Health is seeking a Regulatory Document Specialist, Sponsor Dedicated, based in Serbia.

The role independently manages assigned document deliverables and workflows, ensuring documents are completed in high-quality, Ready for Submission (RFS) format within agreed timelines and in accordance with regulatory and organizational requirements.

**Key Responsibilities:**

- Independently manage assigned document packages and associated workflows to support timely delivery of submission-ready documentation.

- Serve as a knowledgeable resource to colleagues and stakeholders on document preparation, RFS standards, eDMS processes and associated tools.

- Provide training, guidance and day-to-day support to users, including those in CROs.

- Take ownership of assigned document activities, proactively identifying risks, escalating issues, and supporting resolution.

**Process Improvement:**

- Support small to medium-sized process improvement initiatives and project activities.

- Support the maintenance and continuous improvement of departmental processes, templates and guidance documents.

- Partner with stakeholders to identify document management needs and recommend practical improvements.

**Document Management:**

- Binder management in the eDMS for clinical and nonclinical functions.

- Ensure that all eDMS properties are completed.

- Support appendix development activities and track progress.

- Ensure hyperlinks between documents are created where required.

**Technical Expertise:**

- Maintain up-to-date working knowledge of Regulatory guidance on eCTD-compliance.

- Apply technical expertise to evaluate and resolve document formatting, metadata, workflow and structural issues.

- Perform technical quality reviews of documents.

**Requirements:**

- 2-5 years of experience as a Document Specialist within a CRO or pharmaceutical environment.

- Strong interest in leveraging and implementing new technical tools.

- Flexible and adaptable, with the ability to reprioritize and work effectively under pressure.

- Excellent time management skills.

- Experience with eDMS, Microsoft Word, PDF tools, and hyperlinking tools.

- Solid understanding of document management best practices and Good Clinical Practice (GCP).

- Proficiency in Microsoft Office applications and Adobe Acrobat.

**Nice to Have:**

- Experience within a pharmaceutical environment.

- Advanced degree in a relevant discipline.

## Skills

### Required
- eDMS
- Microsoft Word
- PDF tools
- hyperlinking tools
- document management
- Good Clinical Practice

### Nice to have
- Veeva Vault
- authoring tools

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/SRB-Belgrade/Regulatory-Document-Specialist--Sponsor-Dedicated--based-in-Serbia_25113896?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)