Regulatory Operations Publisher
Veristat - MA, United States
Work at Veristat
Overview
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Overview
The Regulatory Operations Publisher supports the Medical Writing and Regulatory Affairs team with the finalization and publishing of regulatory documents for electronic submission. S/he plays a crucial role in representing the regulatory operations group in publishing pivotal research documentation, and its timely delivery therein.
The Regulatory Operations Publisher coordinates internal publishing activities, and provides training and support on publishing and formatting processes and software. S/he also performs quality control review tasks and administrative duties as requested.
What we do
For more than 30 years, Veristat has built a reputation as global experts in clinical development.
- 760+ Rare Disease Clinical Trials supported
- 160+ Marketing Applications supported
- In 2022 we supported 8 marketing application that received regulatory approval
- Learn more about our core values here!
What we offer
- The estimated hiring range for this role is $60,000 - $80,000 plus applicable bonus. This hiring range is specific to the US 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 with at least 1-2 years of 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.
- Excellent writing skills (e.g., English usage), a keen attention to detail, and strong verbal and interpersonal communication skills.
- Proficiency with medical and statistical terminology.
- Ability to communicate and collaborate effectively in project teams.
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.
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