Submission Specialist

Job Overview

The Submission Specialist will collaborate closely with project management, account teams, editorial staff, copy, and junior specialists to ensure submissions adhere strictly to all platform criteria.

Key Responsibilities

• Master the requirements of submission platforms to become the go-to expert.
• Act as the main liaison for all submission-related inquiries and instructions.
• Serve as the internal quality controller for submission packages.
• Participate in initial and ongoing training to stay current on submission protocols.
• Verify the accuracy of information in job starter forms and project briefs.
• Ensure mandatory materials such as PI and ISI are correctly represented in submissions.
• Validate file formats and naming conventions according to guidelines.
• Confirm inclusion of all supporting materials including references, layout markers, and functional notes.
• Check tagging and referencing within systems for correctness.
• Build knowledge of the reference library and monitor expiration dates.
• Work alongside team members to address issues and questions related to submissions.
• Continuously seek improvements in process and quality standards.
• Coordinate with account teams to list brand standards and global mandatory requirements.
• Manage and update a submission calendar for the brand team.
• Understand OPDP submission guidelines and perform quality control reviews.
• Handle multiple submissions and deadlines simultaneously.
• Keep accurate documentation of submission activities.
• Offer guidance and support to junior submission specialists as required.

Qualifications and Requirements

• Minimum of five years' experience in pharmaceutical advertising with a firm grasp of regulatory review procedures.
• Exceptional organizational and planning abilities, combined with meticulous attention to detail.
• Strong oral and written communication skills, with fundamental understanding of scientific material.
• Prior experience in account management or project management is preferred; however, candidates from copywriting or editorial fields are eligible and can be trained.
• Proficient use of MLR Submission Platforms, Microsoft Office Suite, and Adobe Acrobat.
• Self-motivated, adaptable, quick to learn, and capable of working independently.
• Bachelor’s degree or comparable professional experience is required.