Regulatory Publishing Manager Job at Planet Pharma, Princeton, NJ

WHRMOHlQWmRFdlJHbDNNSUlPbnBvUStNUXc9PQ==
  • Planet Pharma
  • Princeton, NJ

Job Description

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:

  • Veeva Vault Experience
  • 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

Job Tags

Similar Jobs

Pacific Rail Services

Rail Terminal Laborer Job at Pacific Rail Services

**NO EXPERIENCE REQUIRED* - Entry level Position - Hiring Immediately! PRS Auto is seeking individuals to unload (drive) new automobiles...  ..., NC. OUT OF AREA candidates and/or those requiring a relocation will NOT be considered. You'll typically work first shift... 

Greco and Sons

Forklift Operator - Part Time Job at Greco and Sons

$18.50/hour Day Shift Part time - Flexible scheduling JOB SUMMARY Responsible for putting away inbound produce. RESPONSIBILITIES Receives and puts away all inbound produce. Ensures product is put away in proper rotation (FIFO). Safe operation... 

Century Rehabilitation

Speech Language Pathologist (SLP) - Full Time or PRN - Lena, IL Job at Century Rehabilitation

_*Caring.Committed.Compassionate.Complete*__*Speech Language Pathologist - Full Time w/ Benefits or PRN*__*** Must have current IL license***_ Century provides Physical Therapy, Occupational Therapy and Speech-Language Pathology to patients in skilled nursing and... 

Hudson Health

Summer Marketing Internship Job at Hudson Health

 ...Marketing Internship Location : New York City (Hybrid: In-Person & Remote) Type : Part-Time Company : Extension Health Reports...  .... Key Responsibilities Assist in writing and optimizing SEO-friendly blog posts, email newsletters, and web content Plan,... 

Jobot

Senior Estimator (Federal Projects) Job at Jobot

 ...Job Description Job Description Established, Top Tier General Contractor Seeks Estimator that will evolve into a leadership role This Jobot Job is hosted by: Ross Theel Are you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume...