Submission Specialist

Role Overview and Responsibilities

This position involves collaborating intensively with project management, account teams, editorial staff, copywriters, and junior submission specialists to guarantee that all elements of submission adhere strictly to platform standards.

• Attain expert-level knowledge of system submission requirements.
• Serve as the main contact point for submission-related needs and offer guidance accordingly.
• Act as the internal quality controller for submission packages.
• Participate in initial and ongoing training sessions regarding submission platform updates.
• Verify accuracy of the job starter form and project brief.
• Ensure mandatory components such as PI and ISI are accurately represented within submissions.
• Validate file formats and naming conventions in line with set guidelines.
• Check that all supporting materials, including references, layout markers, and functional annotations, are properly included.
• Oversee precise tagging and linking of references within the system.
• Develop familiarity with the reference library and monitor expiration dates.
• Work collectively to resolve submission-related queries and issues.
• Proactively enhance process standards to uphold quality benchmarks.
• Collaborate with account teams to assemble a comprehensive list of brand standards and global mandatory elements.
• Maintain an up-to-date submission calendar for brand teams.
• Understand OPDP submission mandates and conduct thorough quality control checks.
• Manage concurrent submissions while adhering to deadlines.
• Keep detailed and accurate documentation records.
• Mentor and provide direction to junior submission specialists as required.

Required Qualifications and Skills

• Minimum of 5 years’ experience in pharmaceutical advertising with a firm grasp of the regulatory review process.
• Exceptional organizational and planning abilities combined with meticulous attention to detail.
• Strong written and verbal communication skills with a foundational understanding of scientific content.
• Ideal candidates have a background in account or project management, though applicants from copywriting or editorial roles may also be considered and trained.
• Proficiency in MLR Submission Platforms, Microsoft Office Suite, and Adobe Acrobat.
• Self-motivated, adaptable, quick learner with a proactive approach.
• Bachelor’s degree or equivalent professional experience is mandatory.