Regulatory Publishing Specialist- Veeva Experience Required

Regulatory Publishing Specialist - Veeva Experience Required Join to apply for the Regulatory Publishing Specialist - Veeva Experience Required role at Syneos Health. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously simplify and streamline our work to make Syneos Health easier to work with and easier for you 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 about changing lives. Job Responsibilities Performs assembler tasks within the document publishing system, including creating publications, modifying outlines, assigning and transforming documents, and adding cross references. Performs publishing tasks within the electronic publishing system, including adding special sheets, applying rules, preparing for publishing, and publishing. 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). Takes lead role in preparing full application submission builds. Troubleshoots issues with eCTD builds and provides guidance to the 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. Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals, etc.) for submission to global regulatory authorities. Leads the team to produce compliant, submission‑ready PDFs from the Word source files. Completes report‑level publishing (CSR, DSUR, PSUR, Protocols). Completes CSR submission assembly. Qualifications & Experience 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 to reduce time‑to‑file and promote global document reusability. SME on global submission‑ready standards, Word format, PDF formatting. Mid‑level position with assembler and publishing tasks within a 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. Equivalent experience, skills, and/or education considered; qualifications may differ from those listed. EEO Statement This 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. The company is fully compliant with the EU Equality Directive and all relevant national laws governing recruitment and employment. 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 according to defined processes and operating procedures, which may be subject to internal and external audit. #J-18808-Ljbffr