Regulatory Publishing Manager – Contract

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $65 - $75 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Vertex Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1989

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Vertex Pharmaceuticals is a global biotechnology company focused on creating transformative medicines for people with serious diseases. With a commitment to scientific innovation, Vertex engages in the discovery, development, and production of cutting-edge therapies, particularly for conditions such as cystic fibrosis, sickle cell disease, and pain management. The company also emphasizes corporate responsibility and diversity within its inclusive culture to drive innovation and improve patient lives.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. • Overtime pay in accordance with federal and state requirements.