Document Publishing Specialist

This is a fully remote position, open to applicants in California.

📋 Description

• Offer support and direction for the Document Finalization Team

• Provide training and mentorship for fellow team members

• Assist management in the allocation and prioritization of publishing projects and tasks

• Anticipate and address technical and operational challenges

• Respond to customer requirements and manage non-standard requests

• Contribute to or establish SOPs and work instructions for controlled, compliant regulatory documents and systems

• Influence management on significant decisions impacting the team

• Act as the subject matter expert in cross-functional projects and initiatives

• Generate final eCTD-compliant PDFs of medical regulatory documents utilizing publishing software

• Review and format Word documents to integrate compliance requirements in source files

• Convert Word files into PDFs

• Execute bookmarking and hyperlinking

• Review and edit PDFs to align with regulatory standards

• Conduct peer reviews of documents produced by colleagues

• Format documents in accordance with style and template specifications

• Upload and retrieve documents from document management systems

• Deliver new document types as internal and external environments evolve

• Perform editing and quality reviews

• Collaborate with document delivery teams to ensure seamless delivery of final documents

⛳️ Requirements

• Exceptional attention to detail

• Strong organizational capabilities

• In-depth understanding of electronic document publishing principles

• Familiarity with regulatory submission requirements

• Knowledge of document lifecycle management in a regulated context

• Proficiency in document management, formatting, and publishing

• Awareness of electronic publishing standards and regulatory document requirements

• Experience in generating eCTD-compliant PDFs with publishing software

• Capacity to review and format Microsoft Word documents for compliance

• Skill in performing PDF bookmarking and hyperlinking

• Ability to conduct document reviews, editing, and quality assurance

• Competence in uploading and retrieving documents from document management systems

• Capability to provide guidance and training for team members

• Proactive in anticipating and resolving technical and operational issues

🏝️ Benefits

• Opportunities for career development and advancement

• Supportive and engaged management

• Training in technical and therapeutic areas

• Peer recognition and comprehensive rewards program

• Inclusive workplace culture

• Company car or car allowance

• Medical, dental, and vision health benefits

• 401(k) company match

• Option to participate in Employee Stock Purchase Plan

• Potential to earn commissions or bonuses based on company and individual performance

• Flexible paid time off (PTO)

• Sick leave

• Reasonable accommodations when applicable