The Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices.
Primary Responsibilities:
• Using eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices.
• For authored documents, ensure formatting is applied consistently according to Style Guide.
• As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness.
• QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues.
• Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM.
• For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices).
• For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion.
• As needed, work with system business owners, IT, and QA to support system. implementations and updates including execution of validation scripts.
Skills
Must have experience with/be proficiency in the following:
• Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems.
• Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems.
• Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates).
• Understanding of computer system validation principles and change control processes.
• Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports.
• Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions.
Education
...and in the Springfield, Oregon area and coordination of day-to-day clinic operations; monitors the activities of all direct patient care office operations components to ensure clinical objectives are met. The Practice Manager provides expertise and leads by example to...
...potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect. If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.****@*****.***...
...compassionate care environment, empowering you. Business Office Manager (BOM) Benefits: ~ Medical/Dental/Vision/Life coverage ~401K... ...: Bachelor's degree or equivalent. SNF (Skilled Nursing Facility) BOM or Assistant BOM experience required. Working knowledge...
...potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect. If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.****@*****.***...
...SBT is the exclusive executive recruiting firm for this confidential position. This confidential company is strategically bringing on a hands-on technical STA lead. In this role, the timing design expert will be collaborating cross-functionally with a talented team...