Promotion Submission Specialist

Job Description Summary
The Promotion Submission Specialist works with some independence under limited supervision to prepare and submit 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).

Job Description

Promotion Submission Specialist
Location – Hyderabad #LI Hybrid

Major Accountabilities:

- Responsible for the electronic submission preparation of promotional materials at time of first use.
- Responsible for the electronic submission preparation of other promotional materials, including requests for advisory comments and pre-submission of promotional materials for products under accelerated approval.
- Proficient with the electronic review system for promotional materials to perform assigned submission tasks.
- Assists in the development, implementation, and maintenance of administrative procedures, working practice documents, and SOPs relevant to the submission of promotional materials.
- Remain current on FDA regulations and guidance, legal requirements, and Novartis document standards relating to the preparation and submission of promotional materials.
- Responsible for prioritizing and tracking promotional submissions, including managing daily workload.
- Interfaces with Regulatory Advertising and Promotion Reviewers, DRA Ops, especially publishers, IT, CA&PE, Brand Marketing, and Ethics and Compliance.
- Leverages AI tools to streamline tasks, generate content, and support decision-making, demonstrating practical fluency in prompting, interpreting, and refining AI outputs to improve work quality and efficiency.

Minimum Requirements:

- BS Degree or equivalent in education and/or experience preferred.
- 1-2 years pharmaceutical experience preferred.
- A 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.

Location: Hyderabad NKC | Hybrid | 3 days a week in office is mandatory.

Availability and willingness to work and be available during US business hours (6:00 pm to 10:00 pm IST or 7:30 am to 11:30 am EST), schedule coordination in advance to ensure US Holiday coverage, and on call for critical matters, based on business needs.

Skills Desired
Clinical Research, Clinical Trials, Curious Mindset, Drug Development, Medical Information, Medical Writing, Military Intelligence, Patient Care, Physics, Technical Support