Job ResponsibilitiesThe 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.Key responsibilities include supporting the preparation and publication of regulatory submission content, applying electronic document compliance requirements, managing document quality control processes, resolving formatting and technical issues, and contributing to the continuous improvement of document production workflows and best practices.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.Primary 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 possibleRender 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 requirementsUploading and/or retrieving documents from document management databases to meet customer needsDelivering new document types as internal and external environment changesEditing / Quality reviewsPartner effectively with other document delivery areas to ensure smooth delivery of final documents.At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a 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, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.Salary Range:$47,000.00 - $79,900.00The 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.Get to know Syneos HealthOver 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.Additional InformationTasks, 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.
about 2 months ago