Merck seeks a Global Submissions Publishing Specialist to manage the assembly, quality control, and delivery of regulatory dossiers to health authorities. The role ensures submission compliance with integral regulatory standards and internal guidelines while meeting critical project deadlines.
Responsibilities
Execute comprehensive submission publishing process including quality control, verification, and delivery of regulatory dossiers
Ensure timely finalization and submission of all dossier assemblies to meet project deadlines
Collaborate with authors, contributors, and cross-functional stakeholders to drive high-quality regulatory outputs
Identify, assess, and resolve risks or issues impacting submission completion; escalate as needed




Provide mentoring to internal and external stakeholders on regulatory requirements and publishing compliance
Requirements
Bachelor's degree plus 5 years of relevant regulatory publishing experience
Fluent English proficiency, written and verbal
Proficiency with publishing tools such as Veeva, Insight Publisher, or Lorenz Docubridge
Advanced skills in Microsoft Word and Adobe Acrobat Professional
Strong organizational and time management abilities for multiple concurrent assignments
Demonstrated problem-solving, critical thinking, and quality compliance awareness
Ability to communicate effectively across diverse cultural contexts

📌 Global Submissions Publishing Specialist (Regulatory Affairs) (Estado de México)
🏢 Merck
📍 Estado de México