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Publishing Specialist I

Company: Worldwide Clinical Trials - USA
Location: San Antonio
Posted on: August 7, 2022

Job Description:

Who we are: We re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. What you will do: The Publishing Specialist I will compile and publish scientific and regulatory reports according to Worldwide Clinical Trials, FDA and sponsor requirements. The Publisher's responsibilities include, but are not limited to, the following:

Reads source documentation, including protocols and standard operating procedures (SOPs), and understands proper approach for compilation of documents for clinical study reports (CSRs). Verifies all materials/information needed to compile the report are provided. If necessary, promptly notifies responsible party about need for additional information/material or clarification. Efficiently uses computer software (such as MS Word, MS Excel, Adobe Acrobat with ISI Toolbox and other publishing software) to compile and revise reports and other documents. Proofreads and edits own work for grammar, spelling, punctuation, and format. Meets timelines for producing draft and final CSRs. Notifies appropriate person if errors are noted in document and requests clarification or corrected document. Uses proper file naming conventions and creates/maintains proper network directory structure for the storage and archival of document files Distributes draft versions of CSRs and other documents to appropriate reviewers. Updates document as instructed by reviewers. Prepares CSRs and related regulatory documents for finalization in accordance FDA PDF Specifications document. Verifies published CSRs meet quality standards, ICH and eCTD requirements. Provides quality review of CSRs and other documents to assess accuracy and compliance. Prepares outgoing shipments and keeps records of completed reports. Updates notes for the department as needed.

What you will bring to the role: Advanced computer skills, including working knowledge of Microsoft Office products Ability to interact effectively with superiors, peers, and other employees Ability to work on multiple projects, prioritize tasks, and meet deadlines. Ability to prioritize and coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events Ability to interact professionally and to work independently or in teams Excellent oral and written skills

REQUIREMENTS: Required: Bachelor's degree Preferred: 1-2 years experience

Keywords: Worldwide Clinical Trials - USA, San Antonio , Publishing Specialist I, Advertising , San Antonio, Texas

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