[Hiring] Principal Regulatory Operations Publisher @Veristat

Role Description

The Principal Regulatory Operations Publisher independently leads publishing projects to success and internally supports the Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams in doing so. S/he leads the finalization and publishing of regulatory documents for electronic submission. The Principal Regulatory Operations Publisher plays a crucial role in representing the Regulatory Operations group in critical business activities, serves as a mentor to junior team members, and acts as a point of escalation for technical questions and troubleshooting.

Qualifications

• Bachelor’s Degree, preferably in a scientific discipline, with at least 8 years of relevant experience in regulatory publishing in a contract research organization (CRO), pharmaceutical, biotechnology, or other clinical setting required.
• Proficiency in Adobe Acrobat, ISIToolbox, publishing software (e.g., eCTDmanager, DocuBridge, eCTDXpress, etc.) and advanced formatting using Microsoft Word styles and templates, including EndNote software required.
• Demonstrated ability to effectively lead a project team required.
• Demonstrated ability to independently manage major dossier submissions or amendments of varying complexity and scope required.
• Experience with global submissions (including FDA and EMA) and post-marketing submissions strongly preferred.
• Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills required; ability to serve as a consultative partner therein.
• Proficiency with medical and statistical terminology required.
• Ability to communicate and collaborate effectively in project teams required.

Requirements

• Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

Company Description

• Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
• 105+ approved therapies for marketing applications prepared by Veristat.
• 480+ oncology projects in the past 5 years.
• 350+ rare disease projects delivered in the past 5 years.
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams.