Promotion Submission Specialist

Overview

The Promotion Submission Specialist prepares and submits promotional material submissions to the Office of Prescription Drug Promotion (OPDP) and the Advertising and Promotional Labeling Branch (APLB) at the Food and Drug Administration (FDA), working with some independence under limited supervision.

What you'll do

• Prepare electronic submissions of promotional materials at time of first use.
• Prepare electronic submissions of other promotional materials, including requests for advisory comments and pre-submission of promotional materials for products under accelerated approval.
• Use the electronic review system for promotional materials to perform assigned submission tasks.
• Assist in the development, implementation, and maintenance of administrative procedures, working practice documents, and SOPs relevant to the submission of promotional materials.
• Stay current on FDA regulations and guidance, legal requirements, and Novartis document standards relating to the preparation and submission of promotional materials.
• Prioritize and track promotional submissions, including managing daily workload.
• Interface with Regulatory Advertising and Promotion Reviewers, DRA Ops (especially publishers), IT, CA&PE, Brand Marketing, and Ethics and Compliance.
• Leverage AI tools to streamline tasks, generate content, and support decision-making, including prompting, interpreting, and refining AI outputs.

What you'll need

• BS Degree or equivalent in education and/or experience.
• Working knowledge of the PC desktop environment and the Microsoft suite of products.
• Experience with Adobe Acrobat and other operating submissions systems.
• Speed and flexibility focused on the timely delivery of quality submissions.
• Ability to plan and prioritize workload.
• Ability to learn new systems/programs.
• Analytical and problem-solving skills associated with document reviews and inquiries.
• Effective communication and interpersonal skills with the ability to interact with individuals at various levels of the organization.
• Highly motivated and a self-starter.

Nice to have

• 1-2 years pharmaceutical experience.

Details

• Location: Hyderabad NKC, hybrid, with 3 days a week in office mandatory.
• Availability and willingness to work during US business hours (6:00 pm to 10:00 pm IST or 7:30 am to 11:30 am EST), with schedule coordination in advance to ensure US holiday coverage, and on call for critical matters based on business needs.