Principal Regulatory Operations Publisher

Veristat•Quebec, ON

10d•$100,000 - $120,000

About The Position

The Principal Regulatory Operations Publisher independently leads regulatory publishing projects and supports Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams. The role leads the finalization and publishing of regulatory documents for electronic submission. It represents the Regulatory Operations group in critical business activities, mentors junior team members, and serves as an escalation point for technical questions and troubleshooting.

Requirements

Bachelor’s degree, preferably in a scientific discipline.
At least 8 years of relevant regulatory publishing experience in a CRO, pharmaceutical, biotechnology, or other clinical setting.
Proficiency in Adobe Acrobat, ISIToolbox, publishing software such as eCTDmanager, DocuBridge, or eCTDXpress, and advanced Microsoft Word formatting using styles and templates, including EndNote.
Demonstrated ability to effectively lead a project team.
Demonstrated ability to independently manage major dossier submissions or amendments of varying complexity and scope.
Excellent writing skills, including English usage, 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.

Nice To Haves

Experience with global submissions, including FDA and EMA submissions, and post-marketing submissions.

Responsibilities

Independently lead regulatory publishing projects through successful completion.
Support Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams.
Lead the finalization and publishing of regulatory documents for electronic submission.
Represent Regulatory Operations in critical business activities.
Mentor junior team members.
Serve as a point of escalation for technical questions and troubleshooting.
Manage major dossier submissions or amendments of varying complexity and scope.