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Regulatory Publishing Manager (Contract)

Roles & Responsibilities

  • 5–7 years of global regulatory publishing experience
  • Strong knowledge of eCTD structure and electronic submission requirements
  • Advanced Microsoft Word formatting expertise and experience generating submission-ready PDFs
  • Experience with Veeva Vault Publishing (direct experience strongly preferred)

Requirements:

  • Format and structure complex regulatory documents in Word to submission-ready standards, including hyperlinks, bookmarks, cross-references, and linking best practices
  • Convert Word source files into compliant, high-quality PDFs and manage document workflows within Veeva Vault Publishing, including dynamic linking
  • Support submission-level publishing for reports (clinical reports, protocols, periodic reports) and ensure alignment with global regulatory standards and eCTD requirements
  • Collaborate with authors and subject-matter experts to embed quality early, guide submission-ready formatting standards, refine templates/checklists, and manage multiple concurrent document priorities independently

Job description

Job Description:

The Regulatory Publishing Manager supports document-level regulatory publishing activities within a global Veeva Vault Publishing environment. This role focuses on preparing submission-ready regulatory documents through advanced Microsoft Word formatting, dynamic linking within Veeva, and compliant PDF generation. This position works within submission documents to ensure technical accuracy, formatting quality, and alignment with global regulatory standards. The role partners closely with document authors and regulatory stakeholders to embed quality into source documents, reduce time-to-file, and improve document reusability. This is an evolving environment requiring a self-starter comfortable working with refining templates, checklists, and processes.

 

Key Duties and Responsibilities

  • Format complex regulatory documents in Microsoft Word to meet submission-ready standards.
  • Apply structured formatting, hyperlinks, bookmarks, cross-references, and linking best practices.
  • Convert Word source files into compliant, high-quality PDFs.
  • Work within Veeva Vault Publishing to manage document workflows and dynamic linking functionality.
  • Support report-level publishing (e.g., clinical reports, protocols, periodic reports).
  • Ensure alignment with global regulatory publishing standards and eCTD requirements.
  • Partner with document authors and SMEs to build quality into Word source documents early.
  • Provide guidance on submission-ready formatting standards.
  • Support refinement of evolving submission checklists and templates.
  • Manage multiple concurrent document priorities independently.

Knowledge and Skills

  • 5–7 years of global regulatory publishing experience.
  • Strong knowledge of eCTD structure and electronic submission requirements.
  • Experience with Veeva Vault Publishing (direct experience strongly preferred).
  • Advanced Microsoft Word formatting expertise.
  • Experience generating submission-ready PDFs.
  • Ability to work independently in a developing, non–cookie-cutter environment.
  • Strong attention to detail and quality mindset.
  • Effective cross-functional communication skills.

Education and Experience

  • Bachelor’s degree preferred but not required.
  • Experience supporting global regulatory submissions required.
  • Experience working in a system transition or evolving publishing environment preferred.

Contract Length: Through the end of the year, with the chance to extend

Pay Range:

Pay dependant upon experience

Shift/Hours:

Monday - Friday. Remote. EST hours. 

Requisition Disclaimer:

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.

 

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

 

No C2C or Third-Party Vendors

 

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