ClinChoice - Labeling Operations Manager, Associate Consultant

Colombia2h ago

In Office Junior LATAM Life Sciences Associate Operations Manager Microsoft Word Documentation Team Management Reporting Document Management

Requirements

• Qualifications and skills necessary for performance of responsibilities, including education, relevant experience, licenses, certifications, and technical and managerial skills. • Education • Bachelor's degree required, preferably in a science or life sciences-related field. • 0-2 years of practical experience. • Labeling Operations Manager - Associate 1 • Excellent written and verbal communication skills. • Complete fluency in English. • Proven strength in logical, analytical and writing ability. • Clear and effective written and verbal communication skills. • High attention to detail. • Excellent computer skills and proficiency with Microsoft Word and similar applications. • Labeling Operations Manager - Associate 2 (in addition to Associate 1) • Identifies and resolves problems proactively. • Project Management Capability and Organizational Skills • Demonstrated project management skills and attention to detail. • Ability to assess and manage project timelines. • Ability to multitask, prioritize and manage multiple projects. • Ability to identify and resolve problems proactively. • Appropriate decision-making, including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders. • Ability to liaise with stakeholders using effective means of communication. • Ability to apply labeling regulatory guidance on formatting requirements. • Ability to consolidate comments from multiple sources, such as emails and meeting minutes. • Knowledge of labeling guidance and policies related to technical and formatting requirements, such as the QRD template and PLR format. • Ability to prepare submission-ready documents. • Organizational Relationships • Provide the primary groups or key roles with which this role interacts regularly, including external interactions as appropriate. • The Labeling Operations Manager, Associate reports to the Labeling Operations Manager, Team Lead.

Responsibilities

• Support the review and delivery of labeling documents and their associated Patient Labeling Documents. The LOM, Associate supports non-complex products and projects. • Labeling Operations Manager - Associate 1 • Provides operational support for project tasks, including: • Prepare comparison tables for labeling team discussions. • Generate necessary renditions, such as clean and marked PDF and clean and marked Microsoft Word, and bookmark renditions as appropriate. • Facilitate document management workflows through the appropriate document management system. • Finalize documents after QC. • Notify internal stakeholders of the availability of labeling documents. • Ensure compliance with Company submission standards, policies and procedures. Ensure all actions follow applicable SOPs and associated documents so that high-quality delivery and compliance are maintained. • Labeling Operations Manager - Associate 2 (in addition to Associate 1) • Provides operational support for simple projects, including: • Consolidate comments from Labeling reviewers and Regulatory Authorities. • Edit and format labeling documents and ensure compliance with the appropriate template, such as QRD or PLR. • Update and maintain the CDS log. • Set clear targets for review and approval timelines using effective project management. Follow up with Labeling Team members to ensure deadlines are met. • Ensure appropriate tracking of labeling projects through defined procedures and optimal use of systems. • Provide shadowing opportunities to Trainee LOMs.