Lead Associate, Regulatory Compliance

2 weeks ago

New York, New York, United States Publicis Health Full time
Job Overview

Company Overview:
Publicis Health is a cohesive, multidisciplinary team dedicated to delivering exceptional services in a dynamic and adaptable manner. We place our clients at the forefront, driving brand engagement swiftly by integrating real-time insights with top-tier creative, content, and media strategies to foster growth and maximize return on investment.

Our approach is a unified solution that merges data, media, and production capabilities. Leveraging the extensive Publicis Groupe network, we are uniquely equipped to provide innovative solutions and specialized expertise to our clients, while also offering enriching opportunities and inclusive benefits to our workforce. We pride ourselves on blending the innovative spirit of a startup with the reliability and expertise of a global leader.

Position Summary:

The Senior Associate, Regulatory Operations is responsible for adhering to the protocols established by our pharmaceutical clients during the submission of marketing materials for regulatory evaluation. This role encompasses the preparation of complete editorial content for the Medical-Legal-Regulatory (MLR) review board, which consists of professionals including medical doctors, legal experts, and FDA regulation specialists. Responsibilities include submitting materials to clients in accordance with their specifications and monitoring the progress of each project through the various phases of MLR review.

Key Responsibilities:
  • Assess the time and resources needed for each submission.
  • Develop a timeline and delegate responsibilities to team members for the delivery of submission components.
  • Oversee the creation of submission components, ensuring compliance with client and Publicis Health standards.
  • Maintain a detailed and accurate dashboard of all current and upcoming submissions, including review stages, job codes, and deadlines.
  • Timely follow-up with client representatives to ensure submissions are received punctually and meet all client expectations.
  • Serve as the primary liaison between the agency and the clients' MLR Review department, providing information on submission requirements and addressing procedural inquiries.
  • Develop, update, and share departmental procedures specific to the clients supported.
Qualifications:

A minimum of a bachelor’s degree and 2-4 years of experience in preparing complex deliverables under tight deadlines is essential. Proficiency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite is required. Experience in direct client communication is necessary. Strong attention to detail and clear communication skills are critical. Preferred qualifications include clear and concise technical writing abilities, along with experience in the Pharmaceutical or Healthcare sectors.

All information will be kept confidential in accordance with EEO guidelines.

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