Global Submissions Publishing Specialist (Regulatory Affairs)

Job Description

Position Title  

Specialist, Global Submissions Publishing (GSP) 

Department 

Regulatory Planning and Publishing (RPP) 

Brief Description of Position 

Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions. 

Submission Publishing is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, facilitating expeditious agency reviews that align with industry cycle times.  

Key Responsibilities of Submission Publishing:  

• Submission Activities Support: Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers and archiving to ensure compliance with industry standards and regulatory requirements. 

• Timely Completion of Submission Assemblies: Ensure that all dossiers are finalized and submitted by the specified deadlines to uphold project schedules and achieve organizational objectives. 

Shared Responsibilities: 

• Collaboration: Collaborate with authors, contributors and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success. 

• Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness. 

• Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines and training materials to support publishing processes. 

• Continuous Learning and Development: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.  

• Risk Management and Issue Resolution: Identify, assess, and actively resolve or escalate any risks or issues that could impact the successful completion of submissions. Collaborate with cross-functional teams to ensure timely identification and mitigation of potential challenges.  

• Mentoring: Provide mentoring to inter-departmental and external stakeholders to enhance understanding and compliance with regulatory requirements.  

Qualifications, Skills & Experience  

Education Minimum Requirement:   

• Bachelor’s Degree plus 5 years of relevant experience  
• Fluent- Full English Porcifiency
• Publishing experience
• Familiarity with tools like, with tools such as: Veeva, Insight Publisher, Lorenz Docubridge
• Computer Systems Aptitude

Required Experience:  

• Interpersonal Skills: Ability to work collaboratively with others and communicate effectively, both verbally and in writing.  

• Technical Proficiency: Proficient in computer programs such as MS Word and Adobe Acrobat Professional, with a demonstrated ability to learn new systems and technologies quickly.  

• Time Management: Strong organizational skills to manage multiple time-sensitive assignments efficiently.  

• Adaptability: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.  

• Cultural Sensitivity: Good interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.  

• Quality and Compliance Awareness: Demonstrates an understanding and executes the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.  

• Problem Solving and Critical Thinking: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.  

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