Promotion Submission Specialist

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.