Regulatory Document Specialist, Sponsor Dedicated, based in Serbia

Regulatory Document Specialist, Sponsor Dedicated, based in Serbia

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

At least level C1 English skills essential

The Document Specialist supports Regulatory and submission teams in the preparation of electronic regulatory submissions to health authorities worldwide. 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.

Using the electronic Document Management System (eDMS) and associated tools, the Document Specialist applies technical expertise to support document readiness, resolve document-related issues, and maintain compliance with established standards. The role serves as a knowledgeable resource to authors and stakeholders, provides guidance on document processes and systems, and contributes to continuous improvement initiatives that enhance efficiency, consistency, and compliance.

Ownership/Projects:

• 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 (Ready for Submission) standards, eDMS processes and associated tools within assigned areas of expertise.
• Provide training, guidance and day-to-day support to the users, including those in CROs to ensure documents are created, authored, reviewed and approved according to relevant standard operating procedures (SOPs) or guidelines and that technical standards of final approved documents are compliant with RFS requirements.
• Take ownership of assigned document activities, proactively identifying risks, escalating issues, and supporting resolution to maintain project timelines.

Process Improvement:

• Support small to medium-sized process improvement initiatives and project activities, coordinating stakeholders and tracking deliverables.
• Support the maintenance and continuous improvement of departmental processes, templates and guidance documents.
• Partner with stakeholders to identify document management needs, collect user feedback and recommend practical improvements.

Document Management:

• Binder management in the eDMS for clinical and nonclinical functions (=multi component packages) until approval, including relevant workflows.
• Ensure that all eDMS properties (metadata) are completed; assist users to complete eDMS properties for corresponding documents.
• Support appendix development activities and track progress against agreed timelines.
• Ensure hyperlinks between documents are created where required.
• Include clinical and nonclinical documents within relevant Regulatory Submission binder(s) within agreed timelines.

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 using approved tools and processes.
• Perform technical quality reviews of documents to ensure compliance with established RFS standards and submission requirements.
• Ensure correction of format or architecture errors identified by Regulatory Publishing in documents/binders for incorporation in submissions.

General:

• Attend and contribute to relevant team meetings covering assigned projects.
• Develop knowledge of eDMS, eCTD and associated tools as used for the preparation of submission documents.
• Ensure business support for testing and implementing the upgraded eDMS and authoring tool.

Provide support for the Legacy documents:

• Assist in identifying, locating, organizing the documents to upload into eDMS.
• Identify any need for reformatting the currently available documents.  

Communication:

• Manage the communication of the final (submitted & approved) regulatory documents in order to take appropriate subsequent actions.
• Work collaboratively with the team to ensure deadlines are met, and effectively communicate when support may be required to meet them.
• Work proactively to share expertise and knowledge across teams. 

EHS responsibilities:

• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements.
• Participate in mandatory EHS training.
• Knowledge & Experience (essential):
  • 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, with the ability to forecast and manage workload effectively
  • Experience with eDMS, Microsoft Word, PDF tools, and hyperlinking tools (e.g., ISI Toolbox)
  • Solid understanding of document management best practices and Good Clinical Practice (GCP)
  • Experience with eDMS and authoring tools, ideally Veeva Vault
  • Proficiency in Microsoft Office applications (Word, PowerPoint, Excel) and Adobe Acrobat

Knowledge & Experience (preferred):

• Experience within a pharmaceutical environment (vs CRO) would be advantageous

Education / Certifications (essential):

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or a related discipline.
• Candidates with an Associate degree may be considered with relevant experience

Education / Certifications (preferred):

• Advanced degree (MSc or PhD) in a relevant discipline is a plus.

Language(s) (essential):

• Fluent in English.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.