Document Publishing Specialist

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $47k - $79.9k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Provide support and guidance for the Document Finalization Team • Provide guidance and training for other team members • Assist management with assigning and prioritizing publishing projects and tasks • Anticipate and resolve technical and operational problems • Respond to customer needs and handle non-standard requests • Contribute to or implement SOPs and work instructions for controlled, compliant regulatory documents and systems • Influence management on key team-impacting decisions • Represent the subject matter expert in cross-functional projects and initiatives • Produce final eCTD-compliant PDFs of medical regulatory documents using publishing software • Review and format Word files to embed compliance requirements in source files • Render Word files into PDFs • Perform bookmarking and hyperlinking • Review and edit PDFs to meet regulatory requirements • Perform peer review of documents published by colleagues • Format documents according to style and template requirements • Upload and retrieve documents from document management databases • Deliver new document types as internal and external environments change • Perform editing and quality reviews • Partner with document delivery areas to ensure smooth delivery of final documents

🎯 Requirements

• Strong attention to detail • Excellent organizational skills • Thorough understanding of electronic document publishing principles • Understanding of regulatory submission requirements • Understanding of document lifecycle management within a regulated environment • Expertise in document management, formatting, and publishing • Knowledge of electronic publishing requirements and regulatory document standards • Experience producing eCTD-compliant PDFs using publishing software • Ability to review and format Microsoft Word files for compliance • Ability to perform PDF bookmarking and hyperlinking • Ability to conduct document reviews, editing, and quality control • Ability to upload and retrieve documents from document management databases • Ability to provide guidance and training to team members • Ability to anticipate and resolve technical and operational problems

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive work culture • Company car or car allowance • Medical, dental, and vision health benefits • Company match 401(k) • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations, when appropriate