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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Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Skills Required
- Bachelor's degree, preferably in a scientific discipline
- At least 8 years of relevant regulatory publishing experience in a CRO, pharmaceutical, biotechnology, or clinical setting
- Proficiency in Adobe Acrobat, ISIToolbox, and publishing software such as eCTDmanager, DocuBridge, or eCTDXpress
- Advanced formatting experience using Microsoft Word styles and templates
- Proficiency with EndNote software
- Ability to effectively lead a project team
- Ability to independently manage major dossier submissions or amendments of varying complexity and scope
- Experience with global submissions, including FDA and EMA
- Experience with post-marketing submissions
- Excellent writing skills and English usage
- Keen attention to detail
- Strong verbal and interpersonal communication skills
- Proficiency in medical and statistical terminology
- Ability to communicate and collaborate effectively in project teams
What We Do
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant
