Regulatory Publishing Specialist- Veeva Experience Required

Virginia Commonwealth University; Buenos Aires; Presencial; ARS 700.000 - 900.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical solutions organization is seeking a Regulatory Publishing Specialist in Buenos Aires. The role involves managing document publishing tasks, ensuring compliance with global standards, and leading a team to produce high-quality submission-ready documents. Candidates should have experience with regulatory publishing tools, particularly Veeva Vault Publishing, along with strong collaboration skills. This position offers an opportunity to work in an agile and innovative environment, contributing to the success of therapeutic deliveries.

Formación

• Experience with collaborative authoring and document management.
• Strong understanding of submission-ready standards and formatting requirements.
• Ability to create compliant PDF documents from Word source files.

Responsabilidades

• Perform tasks within the document publishing system, including creating publications.
• Conduct quality control tasks for the publishing output.
• Review and ensure documentation accuracy and compliance.
• Lead the team in producing compliant, submission-ready PDFs.

Conocimientos

Experience with eCTD builds

Knowledge of Veeva Vault Publishing

Attention to detail

Ability to collaborate with SMEs

Herramientas

Extedo’s eCTDManager

eValidator

Acrobat

Descripción del empleo

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.)

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