Principal Regulatory Operations Publisher
Veristat
Job Overview
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Job Description
Principal Regulatory Operations Publisher at Veristat
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. This role 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.
Veristat offers a flexible, inclusive culture with a 70% remote workforce and 66% women-led teams, accelerating life-changing therapies globally for over 30 years.
What Veristat Offers
- Remote working opportunities
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
The estimated hiring range for this role in the USA is $100K and $120K plus applicable bonus. Final salary is determined by various factors including skills, experience, certifications, education, location, and market data.
What Veristat Looks For
- Bachelor’s Degree, preferably in a scientific discipline, with at least 6-8 years of relevant experience in regulatory publishing in a contract research organization (CRO), pharmaceutical, biotechnology, or other clinical setting.
- 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.
- Demonstrated ability to effectively lead a project team.
- Demonstrated ability to independently manage major dossier submissions or amendments of varying complexity and scope.
- 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; ability to serve as a consultative partner.
- Proficiency with medical and statistical terminology.
- Ability to communicate and collaborate effectively in project teams.
Key skills/competency
- Regulatory Submissions
- eCTD Publishing
- Document Finalization
- Project Leadership
- Regulatory Affairs
- Adobe Acrobat
- Microsoft Word Formatting
- ISIToolbox
- Global Submissions (FDA, EMA)
- Mentorship
How to Get Hired at Veristat
- Research Veristat's culture: Study their mission, values, recent news, and employee testimonials on LinkedIn and Glassdoor to understand their patient-centric focus and remote-friendly environment.
- Tailor your resume: Customize your resume to highlight experience in regulatory operations, eCTD publishing, project leadership, and proficiency with specific publishing software mentioned for Veristat.
- Showcase technical expertise: During interviews, emphasize your hands-on experience with Adobe Acrobat, ISIToolbox, eCTDmanager, DocuBridge, and advanced Microsoft Word formatting skills.
- Prepare for behavioral questions: Be ready to discuss past experiences leading projects, mentoring junior team members, and managing complex global regulatory submissions effectively at Veristat.
- Demonstrate attention to detail: Highlight your meticulous writing skills, accuracy in documentation, and ability to ensure regulatory compliance, critical for a Principal Regulatory Operations Publisher.
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