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Regulatory Publishing Specialist - Veeva Experience Required Syneos - Clinical and Corporate - Prod Regulatory Publishing Specialist - Veeva Experience Required 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 continuously look 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 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 accelerate the delivery of therapies, because we are passionate to change lives. Responsibilities Performs assembler tasks within the document publishing system, including creating publications, modifying outlines, assigning and transforming documents, and adding cross references. Performs 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 (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others). Troubleshoots issues with eCTD builds and provides guidance to entry‑level publishers. Provides assistance and guidance to entry‑level 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, clean‑up, and duplication tasks. May receive and deliver client information/documents, with significant supervision. May provide alternatives for completing assigned tasks. Leads team to produce compliant, submission‑ready PDFs from the Word source files. Completes report‑level publishing (CSR, DSUR, PSUR, Protocols). Completes CSR submission assembly. Experience with collaborative authoring and Dynamic Linking in Veeva Vault Publishing would be highly preferable. Experience working closely with Document authors/functional SMEs to ensure global quality is built into the Word source docs to reduce time‑to‑file and promote global document reusability. SME on global submission‑ready standards, Word format, PDF formatting. 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. (The rest of the legal compliance and EEO statement is provided in the original source, omitted here for brevity.) We are committed to compliance with the Americans with Disabilities Act, including the provi… #J-18808-Ljbffr
