Job Description:
Regulatory Operations Publisher
The Regulatory Operations Publisher will serve as an internal team member for electronic submission publishing projects, primarily in eCTD format. He/she will collaborate with colleagues and clients on routine, project related matters. The Regulatory Operations Publisher will be responsible for completing tasks assigned in order to support team members in meeting submission deadlines.
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 look for:
- Bachelor’s degree or equivalent experience
- Strong computer skills, including proficiency with MS Office and Microsoft Word functionality in terms of formatting documents using content templates or MS Word styles
- 0 - 3 years of prior experience using software applications including Adobe Acrobat and MS Office working in a professional environment that demands high utilization of computer and communication skills
- Technical knowledge of US, CA and EU eCTD submission requirements or willingness to learn
- Excellent IT/computer skills
- Excellent written and verbal communication skills
- Ability to compile regulatory submissions with supervision by team leaders
- Work in a role that demands strong attention to detail and organizational skills in a fast-paced environment
- Use simple rules, common sense and experiences to identify issues in the work product
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 or equivalent experience
- Proficiency with MS Office and Microsoft Word formatting using templates or styles
- Experience (0-3 years) using Adobe Acrobat and MS Office in a professional environment
- Technical knowledge of US, CA and EU eCTD submission requirements or willingness to learn
- Excellent IT/computer skills
- Excellent written and verbal communication skills
- Ability to compile regulatory submissions with supervision
- Strong attention to detail and organizational skills in a fast-paced environment
- Ability to identify issues in work product using rules, common sense, and experience
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
