Key Duties & Responsibilities
Manages portfolio views of upcoming submissions and publishing interdependencies and serves as Global Regulatory Publishing subject matter expert
Serve as primary point of contact between cross‑functional team and regulatory publishing vendor.
Monitor vendor KPIs, SLAs, and quality metrics; escalate performance issues or capacity constraints.
Stay current on regulatory publishing trends and best practices, and assess implications for internal processes and vendor partnerships, and ensure vendor adherence to company SOPs, global regulatory requirements, and evolving health authority guidance.
Partner with cross‑functional teams to develop and manage submission publishing timelines, publishing strategy, and resource forecasting.
Ensure submission content is tracked, compiled, validated, and delivered in the required format in compliance with regional requirements.
Perform quality control (QC) reviews on vendor work to ensure submission content meets regulatory and internal standards.
Lead or contribute to the development and continuous improvement of publishing processes, templates, checklists, and SOPs.
Participate in cross‑functional or global working groups focused on submission process innovation or regulatory technology and provide training or guidance to stakeholders on publishing timelines and requirements.
Contribute to long‑term resource planning, including publishing capacity needs.
Required Education Level
Bachelor’s Degree in life sciences or technology area
Required Experience
Typically requires 9 years of Regulatory Operations/Publishing experience or the equivalent combination of education and experience.
Required Knowledge/Skills
Extensive experience in industry‑standard publishing software and validation systems
Vendor management/outsourcing experience
Ability to prioritize a portfolio of publishing activities on selected programs
Ability to train and educate other team members and influence cross‑functional stakeholders in submission‑ready concepts
Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
Strong organization, written/verbal communication, and attention to detail
Knowledge of health authority procedures/guidance regarding electronic submissions.
Expert in Electronic Document Management Systems.
Contract Length
Through the end of the year, with the chance to extend
Pay Range
$90/hr. - $100/hr.
Shift/Hours
Monday - Friday. EST hours. Remote.
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