Job Description
Must Have
Associate Scientific Writing
Role Overview
As the Promotional Review & Veeva Submissions Specialist, the ideal candidate will drive the promotional review and approval (MLR) process. The candidate will manage content annotations, execute Veeva Vault submissions, and provide real-time support during review meetings. The focus of this role is to ensure all brand assets meet regulatory standards while maintaining efficient and compliant content workflows. Core responsibility is to support submission activities, consult with brands for their MLR/PRC (promotional review committee) requirements, notify stakeholders about the status, and resolve and solution MLR comments.
Core Responsibilities
Veeva Vault Submissions & Management
• Prepare, upload, and submit promotional materials for MLR review using Veeva Vault PromoMats.
• Verify job metadata, claims documentation, and proper categorization before workflow initiation.
• Track submission progress, approvals, version histories, and re-approvals, including label-update submissions.
• Create and manage different Veeva document version like Review Versions (RV) and Compliance Versions (CV).
Content Review & Annotation
• Add and manage diverse annotation types—including direct pick, functional, medical, and label annotations—to provide precise guidance for asset updates.
• Ensure all files are accurately linked to appropriate job folders and aligned with brand guidelines.
• Review and structure annotations to support smooth approval workflows and maintain clarity throughout the asset lifecycle.
MLR Meeting Coordination
• Attend MLR meetings to assist reviewers and brand teams in real time.
• Provide background information, annotated materials, and reference documents during reviews.
• Capture feedback, decisions, and next steps directly into Veeva or tracking templates.
• Coordinate review schedules, agenda updates, and meeting invites.
• Resolve MLR comments and consult with brands on their specific requirements.
Cross-Functional Communication
• Maintain clear, concise, and well structured communication across teams to ensure consistent understanding of project goals and requirements.
• Coordinate effectively with cross functional stakeholders through timely updates, transparent discussions, and proactive clarification of expectations.
• Document and communicate key decisions, action items, and progress status to support smooth workflows and team alignment.
Quality Assurance & Operations
• Perform audits of assets to verify all required materials are in place before initiating workflows.
• Conduct thorough quality checks to ensure submissions are accurate, complete, and error-free.
• Maintain weekly review status reports, re-review alerts, and the MLR submission scheduler.
• Identify process challenges and leverage AI-based tools (when needed) to streamline asset categorization and submission process.
• Support internal audits related to MLR operations.
• Leverage AI based tools to efficiently capture, organize, and manage screenshots for creating RV and CV files (if needed).
Good to have
Desired Profile
1. Minimum 2 to 3 years of experience in pharmaceutical industry setting either pharmaceutical companies or agencies in any of the following functions—medical services / medico-marketing / clinical research / regulatory affairs or in medical writing / developing / publishing medical content.
OR
2. A minimum of 2 to 3 years of experience in any clinical practice
3. Candidates with journal publishing and/or conference publications during academia is added advantage.
4. Understanding of any specialty area of medicine (preferred) or an overall understanding of the pharmaceutical and medical knowledge is must.
5. Strong flair and passion for writing.
6. Strong written and verbal communication/presentation skills.
7. Passion for networking.
8. Being up to date with the latest technical/scientific developments and relating them to various projects.
Soft Skills
a. Client focus
b. Result orientation
c. Communicating with Impact
d. Team player
e. Process oriented