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Regulatory Publishing Specialist- Veeva Experience Required

2 semanas atrás

São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro

Description
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 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 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.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE
Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

Under supervision and with guidance from more senior service line colleagues:

  • Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references.
  • Performs Publishing tasks within the electronic publishing system, including, but not limited to, 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 provide 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 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

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 with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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.