Principal Regulatory Operations Publisher

Job Description:

Principal Regulatory Operations Publisher

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.

Make an Impact at Veristat!

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
• Learn more about our core values here!

What we offer:

The estimated hiring range for this role is $100K and $120K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data.  Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

•  Benefits vary by location and may include:
  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retirement plans 

What we look for:

• 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 (eg, 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.

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.

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