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.