Document Publishing Specialist

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.

About the role

The Document Specialist is responsible for providing document management, formatting, and publishing services to support the creation of electronically compliant documents for global regulatory submissions and transparency requirements. This role provides expertise and guidance on regulatory document standards and electronic publishing requirements to ensure submission-ready content that meets health authority and industry specifications, including those of the FDA, EMA, and other global regulatory agencies.

The Document Specialist collaborates closely with cross-functional teams to prepare, format, review, and publish regulatory submission documents, scientific reports, and external publications. The role is actively involved in document production activities, ensuring consistency, quality, compliance, and adherence to established templates, style guides, and regulatory standards.

Responsibilities

• Provide support and guidance for the Document Finalization Team.
• Provide guidance and training for other team members.
• Assist management with assigning and prioritizing publishing projects and tasks.
• Anticipate and resolve key technical and operational problems.
• Respond to and/or anticipate customer needs and handle non-standard requests.
• Contribute to and/or implement SOPs or work instructions to ensure regulatory documents and systems are well controlled and comply with applicable regulations.
• Influence management on key decisions impacting the team.
• Represent as subject matter expert in cross-functional projects/initiatives.
• Perform document finalization/publishing services, including:
  • Function as subject matter expert in document finalization/publishing.
  • Produce final eCTD-compliant PDFs of medical regulatory documents using publishing software.
  • Review and format Word files to ensure as many compliance requirements are in the source file as possible.
  • Render the Word files into PDFs.
  • Perform bookmarking and hyperlinking as needed.
  • Review the PDFs and edit them as needed to ensure that all regulatory requirements are met.
  • Perform peer review of documents published by other colleagues.
• Perform other document tasks as needed:
  • Formatting documents to meet style/template requirements.
  • Uploading and/or retrieving documents from document management databases to meet customer needs.
  • Delivering new document types as internal and external environment changes.
  • Editing / Quality reviews.
• Partner effectively with other document delivery areas to ensure smooth delivery of final documents.

Qualifications

The successful candidate will possess strong attention to detail, excellent organizational skills, and a thorough understanding of electronic document publishing principles, regulatory submission requirements, and document lifecycle management within a regulated environment.

Benefits

• Company car or car allowance.
• Health benefits to include Medical, Dental and Vision.
• Company match 401k.
• Eligibility to participate in Employee Stock Purchase Plan.
• Eligibility to earn commissions/bonus based on company and individual performance.
• Flexible paid time off (PTO) and sick time.

Pay

Salary Range: $47,000.00 - $79,900.00. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.