Submissions Sr. Publisher

The Submissions Sr. Publisher performs the preparation, compilation, and publication of electronic common technical documents (eCTD) and other regulatory submissions for investigational, new, and marketed drugs and devices. The Submissions Sr. Publisher has an increasing level of responsibility and is highly knowledgeable and experienced with complex types of submissions across different regulatory regions and Health Authority communications. The Submissions Sr. Publisher mentors junior team publishers within the Publishing & Submissions department.

The Submissions Sr. Publisher may act as a Subject Matter Expert (SME) in the field of Publishing activities on assigned project teams or may lead a team of Specialists and Publishers. The Submissions Sr. Publisher may have 1 or more direct reports.

• Manages submission timelines and activities for assigned projects to meet or exceed required deadlines
• Performs the formatting, compilation, and publication of regulatory submissions to meet or exceed sponsor and agency requirements and expectations
• Increases skills, knowledge and experience of increasingly complex documents, applications and submission types, amendments to existing applications for lifecycle management purposes
• Develops knowledge and experience of submissions across different regulatory regions as corporate needs dictate
• Learns and keeps abreast of updates to regulatory guidance, law, and best practice related to job functionality
• Mentors less experienced Publishers and Submissions Specialists
• Assists with development and presentation of internal and sponsor training

• With increasing knowledge and experience, manages and oversees submission processes
• May interact with project teams to educate sponsors on technical requirements for submissions
• With increasing knowledge and experience participates in submissions software evaluation, selection, and validation
• Assists with or leads development and improvement of internal best practices and standards for regulatory operations activities. Interacts with regulatory agency technical counterparts to resolve issues and
• Participates in interdepartmental communications to assist with compliance with regulations pertaining to eCTD and other submission types
• Submissions Sr. Publisher with or without direct line reports:
  • Actively supports staff learning & development within the company
    • Provides guidance and advises Project Leads, and/or Project Teams on submissions requirements
    • Participates in meetings with clients to discuss submissions requirement
    • Provides mentorship to team members
    • Acts professionally with peers and clients, knows business etiquette
• Draft and contribute as Subject Matter Expert (SME) in the field of Publishing activities to the evaluation/improvement of processes and procedures within the Quality Management System
• Assures good communication and relationships with (future) clients
• Provide regulatory operations input to proposals and bids·
• Actively manages, develops, and strengthens client relationships, drives repeat business
• Contribute and take part in client evaluations, visits and bid defenses

Requirements

• B.S., M.S., Ph.D., or equivalent degree, in a scientific area preferred, and equivalent combination of relevant experience
• Strong communication skills (written and oral), commensurate with experience, to communicate effectively with a project team and clients, command of English language

• Ability to manage multiple projects and team members to prioritize submissions based on regulatory and sponsor deadlines, complexity, and client cooperation

• Experience with formatting, publishing, and compiling simple and complex eCTD and other submission types

• Strong computer skills, including extensive experience with regulatory submissions software such as DocuBridge and ISI Toolbox, SharePoint, Word, Excel, and PowerPoint required

• RAC Certification preferred

• >2 years’ experience with submissions to US FDA, Health Canada, and European authorities
• Strong regulatory knowledge of drug, biologic, or device development focusing on submission requirements

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