Associate Specialist

About the Role

The Associate Specialist, Global Submissions Publishing (GSP) supports the Regulatory Planning and Publishing (RPP) department. This role is responsible for assembling, linking, and delivering high-quality regulatory dossiers to health authorities, ensuring timely agency reviews.

Key Responsibilities

• Submission Activities Support
• Execute the comprehensive publishing process, including quality control, verification, finalization, delivery of submission dossiers, and archiving.
• Ensure compliance with industry standards and regulatory requirements.
• Timely Completion of Submission Assemblies
• Finalize and submit all dossiers by specified deadlines to uphold project schedules and achieve organizational objectives.
• Collaboration
• Work with authors, contributors, and stakeholders to ensure high-quality outputs and enhance project outcomes.
• Testing and Implementation of New Tools and Processes
• Engage in testing and evaluating 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.
• Continuous Learning and Development
• Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.

Requirements & Tech Stack

• Core Skills
• Interpersonal Skills: Ability to work collaboratively and communicate effectively, verbally and in writing.
• Technical Proficiency: Knowledge of computer programs such as MS Word and Adobe Acrobat Professional. 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 and stay current with new and updated processes.
• Cultural Sensitivity: Good interpersonal skills and experience in handling diverse cultures. Effective communication skills in English and regional languages.
• Quality and Compliance Awareness: Understanding of the business value of quality and compliance, recognizing 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 within job responsibilities.
• Additional Skills (from provided list, not explicitly assigned as responsibilities)
• Adverse Event Report
• Audits Compliance
• Change Management
• Competency Management
• Conceptual Thinking
• Continuous Development
• Data Quality Assurance
• Documentation Maintenance
• Documentation Preparation
• Document Control Systems
• Document Management
• Efficiency Improvements
• Electronic Common Technical Document (eCTD)
• Employee Training Programs
• Lateral Thinking
• Microsoft Word
• Multitasking
• Performance Improvements
• Policy Implementation
• Process Improvements
• Product Delivery
• Records Retention Management
• Regulatory Applications
• Regulatory Communications

Qualifications

• Education
• Minimum Requirement: High School Diploma or equivalent (no relative experience).