Job Title

Regulatory Publishing Specialist- Veeva Experience Required Job Summary Mid-level position that performs assembler and publishing tasks within the publishing system. Under supervision, will support filtering, cleaning, migration, analysis, reporting and publication of regulatory data and information, undertaken according to defined processes and operating procedures, which will be subject to internal and external audit. Company Overview Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a FullService environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Key Responsibilities Perform assembler tasks within the document publishing system, including creating publications, modifying outlines, assigning and transforming documents, and adding cross references. Perform publishing tasks within the electronic publishing system, including adding special sheets, applying rules, preparing for publishing, and publishing. Perform QC tasks within the electronic publishing system and QC of the published output. May QC materials prepared by team or client. May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities. Takes lead role in preparing full application submission builds. Troubleshoot issues with eCTD builds and provide guidance to the entry level publishers. Provide assistance and guidance to entrylevel publishers. May review documents for legibility, completeness, and accuracy. May log and track regulatory documents, publications, and other relevant materials. May organize and compile regulatory documentation, perform pagination, cleanup, and duplication tasks. May receive and deliver client information/documents, with significant supervision. Prepare and assemble applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals, etc.) for submission to global regulatory authorities. Lead team to produce compliant, submissionready PDFs from the Word source files. Complete reportlevel publishing (CSR, DSUR, PSUR, Protocols). Complete CSR submission assembly. Experience with collaborative authoring and Dynamic Linking in Veeva Vault Publishing is highly preferable. Experience working closely with Document authors/functional SMEs to ensure global quality is built into the Word source docs. SME on global submissionready standards, Word format, PDF formatting. Qualifications Midlevel professional with experience in regulatory publishing, document assembly, and electronic publishing systems. Proficiency with Veeva Vault Publishing, eCTDManager, eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, or equivalent. Strong understanding of global regulatory submission requirements and experience preparing IND, NDA, ANDA, DMF and related documents. Excellent attention to detail, strong problemsolving skills, and ability to work independently and as part of a team. Good communication skills and ability to guide junior staff. Benefits & Culture Passionate about developing our people career development, progression, supportive line management, technical and therapeutic area training. Committed to a Total Self culture that promotes authenticity and belonging. Continuous opportunities for learning and growth within a global organization. EEO Statement Syneos Health complies with the Americans with Disabilities Act and the EU Equality Directive, ensuring reasonable accommodations are provided when required. No discrimination will be tolerated in hiring or employment based on race, color, religion, sex, national origin, disability, or any other protected status. Seniority Level Entry level Employment Type Fulltime Job Function Legal #J-18808-Ljbffr