Senior Regulatory Publishing Lead — Remote

Veristat; United States; Remote; USD 100,000 - 120,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams. The role focuses on finalizing and publishing regulatory documents for electronic submission and mentoring junior members.

The role involves representing Regulatory Operations in critical business activities and collaborating across global teams to accelerate therapies for patients worldwide.

Qualifications

• Bachelor’s Degree in a scientific discipline with 8+ years regulatory publishing in CRO/pharma.
• Proficiency in Adobe Acrobat, ISIToolbox, and publishing software like eCTDmanager.
• Ability to lead a project team.
• Experience with global FDA/EMA submissions.
• Excellent writing and communication skills.

Responsibilities

• Lead publishing projects to successful completion and support cross-functional teams.
• Finalize and publish regulatory documents for electronic submission.
• Mentor junior team members and escalate technical questions as needed.
• Represent Regulatory Operations in critical business activities.

Skills

Project leadership

Regulatory publishing experience

Strong writing skills

Communication skills

English terminology proficiency

Education

Bachelor’s Degree in science

Tools

eCTDmanager

DocuBridge

eCTDXpress

ISIToolbox

EndNote

Microsoft Word styles

Job description

Veristat is seeking a Principal Regulatory Operations Publisher to independently lead publishing projects and support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams. The role focuses on finalizing and publishing regulatory documents for electronic submission and mentoring junior members.

The role involves representing Regulatory Operations in critical business activities and collaborating across global teams to accelerate therapies for patients worldwide.