Regulatory Publishing Specialist- Veeva Experience Required

Syneos Health, Inc.; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading biopharmaceutical solutions organization in São Paulo is seeking a Regulatory Publishing Specialist with Veeva experience. The role involves assembling and publishing regulatory documents under supervision, including quality control and team leadership in creating submission-ready materials. The ideal candidate should be detail-oriented and capable of collaborating with various stakeholders to ensure compliance with global standards. This mid-level position offers an opportunity to impact biopharmaceutical success and innovation.

Qualificações

• Experience with document publishing systems, especially Veeva.
• Ability to lead teams in producing compliant submission-ready documents.
• Strong attention to detail and quality assurance in document handling.

Responsabilidades

• Create and modify regulatory publications and documents.
• Perform quality control of published outputs.
• Compile regulatory documentation for submissions.

Conhecimentos

Assembling publications

Publishing tasks in electronic systems

Quality control

Document review

Collaborative authoring

Dynamic Linking in Veeva Vault

Ferramentas

Veeva Vault Publishing

Extedo’s eCTDManager

ISI Publisher

Acrobat

Descrição da oferta de emprego

Regulatory Publishing Specialist- Veeva Experience Required

Description

Regulatory Publishing Specialist- Veeva Experience Required

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 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

• Under supervision and with guidance from more senior service line colleagues:
  • 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 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 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, NDA, ANDAs, DMFs, variations, routine reports, renewals, etc.) for submission to global regulatory authorities.
• Leads team to produce compliant, submission‑ready PDFs from 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 is highly preferable.
• Experience working closely with document authors/functional SMEs to ensure global quality is built into Word source docs to reduce time‑to‑file and promote document reusability.
• SME on global submission‑ready standards, Word format, PDF formatting.

Get to know Syneos Health

Over 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 in a highly competitive and ever‑changing environment.

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.

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.

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.