Senior Regulatory Operations Publisher at Veristat | Torre
Senior Regulatory Operations Publisher
trending_up Invest in Torre
Veristat

Senior Regulatory Operations Publisher

Veristat
Posted by
Manuela Vargas Jaramillo
Full-time

Legal agreement: To be defined

Compensation USD11/hour
Non-negotiable
location_on
Hybrid (United States)
Posted about 6 years ago

Responsibilities

• Serve as publishing lead on cross-functional programs (INDs, NDAs, BLAs) • Serve as the client contact for publishing, including hosting and leading client meetings on publishing • Be responsible for the creation of table of contents tracker for major submissions, including timelines and delegation of specific sections to other members of the publishing team • Be responsible for ensuring that the final exported sequence for submissions contains all of the documents listed in the TOC and ensuring the correct version is included • Be responsible for communicating any potential concerns regarding timelines to the project managers as needed and escalating when appropriate • Format documents in compliance with applicable regulatory agencies and sponsor requirements using Microsoft Word • Create, assemble, and publish major and routine electronic submissions in eCTD format per regulatory and client requirements, including NDAs/BLAs, INDs, annual reports, supplements, amendments, etc. • Serve as the coordinator for internal publishing activities, interacting with project teams to assist with timelines and deliverables related to submission documents and projects • Interface with project managers and medical writers to discuss submission preparation and provide regular updates regarding deliverables • Create submission planners for major submissions (per submission type) • Maintain working knowledge of regulations governing the content and formatting of submission documents, as required by the FDA, ICH, and other regulatory bodies • Perform quality control review tasks and administrative duties as requested • Serve as the internal subject matter expert for training and support on publishing and formatting processes and software • Create and maintain Veristat document templates and styles • Ensure compliance with Veristat internal SOPs and work instructions • Prepare budget estimates and text for proposals that include a publishing component.
This job post is closed.