Net2Source Inc.
Regulatory Publishing Manager
Net2Source Inc. - San Diego, California, United States, 92189
Work at Net2Source Inc.
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$53.59/hr - $56.27/hr Direct message the job poster from Net2Source Inc. Certified LinkedIn recruiter, Senior Talent Acquisition Specialist @ Net2Source Inc. | Postgraduate DegreeOpen for relocation anywhere in…
Title- Regulatory Publishing Manager Duration-06 Months Contract Duties The Manager/Sr. 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 client's 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 client's 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: • Thorough working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies. • 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 Bachelor's degree in business administration, a life sciences discipline, information technology, etc.. A minimum of 5 years in Regulatory Operations or a related, relevant function. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Research, Administrative, and Science Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Net2Source Inc. by 2x Get notified about new Regulatory Specialist jobs in
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$53.59/hr - $56.27/hr Direct message the job poster from Net2Source Inc. Certified LinkedIn recruiter, Senior Talent Acquisition Specialist @ Net2Source Inc. | Postgraduate DegreeOpen for relocation anywhere in…
Title- Regulatory Publishing Manager Duration-06 Months Contract Duties The Manager/Sr. 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 client's 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 client's 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: • Thorough working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies. • 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 Bachelor's degree in business administration, a life sciences discipline, information technology, etc.. A minimum of 5 years in Regulatory Operations or a related, relevant function. Seniority level
Seniority level Associate Employment type
Employment type Contract Job function
Job function Research, Administrative, and Science Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Net2Source Inc. by 2x Get notified about new Regulatory Specialist jobs in
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr