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Lead Manager, Regulatory Compliance Operations

2 months ago

New York, New York, United States Publicis Groupe Full time
Company Overview

Publicis Groupe is a comprehensive, multi-disciplinary organization that delivers exceptional services in a dynamic and adaptable manner. With our clients at the forefront, we drive brand engagement at the pace of everyday life by integrating real-time insights with top-tier creative, content, and media strategies to foster growth and maximize return on investment.

Publicis Groupe operates as a unified solution, encompassing data analytics, media strategies, and production capabilities. By leveraging the extensive resources of our global 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 take pride in merging the entrepreneurial spirit of a startup with the reliability and expertise of a global leader.

Position Overview

The Lead Manager, Regulatory Compliance Operations is tasked with overseeing a substantial team of Associates, Senior Associates, and Managers to guarantee that marketing materials for clients adhere to the protocols established by our pharmaceutical partners for regulatory assessment. This role is pivotal in formulating procedures for internal teams and providing guidance on specific initiatives to facilitate efficient and expedited reviews by clients. The Lead Manager is responsible for identifying and addressing potential challenges across their assigned accounts.

Furthermore, the Lead Manager, Regulatory Compliance Operations must effectively manage, coordinate, and allocate all tasks flowing through their designated brands to ensure the team meets all project deadlines.

Key Responsibilities:
  • Supervise multiple direct reports at the Associate, Senior Associate, and Manager levels, including responsibilities for recruitment, onboarding, training, and professional development.
  • Provide estimates for Statement of Work (SOW) development.
  • Collaborate with the Director of Regulatory Review to develop departmental Standard Operating Procedures (SOPs).
  • Oversee the daily activities of reporting employees, offering project guidance and addressing issues as they arise.
  • Coordinate workflows among reporting staff to ensure adequate coverage for all client requirements, including during absences.
  • Assess the time and resources needed to complete each submission.
  • Establish timelines and assign responsibilities to appropriate team members for the delivery of submission components.
  • Oversee the creation of submission components, ensuring compliance with client and Publicis Health guidelines.
  • Maintain a detailed and accurate dashboard of all current and upcoming submissions, including review stages, job codes, and deadlines.
  • Act as the primary liaison with client MLR representatives.
  • Follow up with client liaisons promptly to ensure submissions are received on time and meet all client expectations and specifications.
  • Create, update, and disseminate client-specific procedures to the department.
Qualifications:

A minimum of a bachelor's degree and 5-8 years of experience in preparing complex deliverables under tight deadlines is required. Proficiency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite is essential. Experience in direct client communication is necessary. A demonstrated understanding of FDA pharmaceutical advertising regulations through appropriate training or prior experience is preferred. Strong communication skills and attention to detail are critical. Excellent technical writing skills are highly desirable. At least one year of experience in the Pharmaceutical Industry, Healthcare, or Advertising Agency is required.

Additional Information:

At Publicis Groupe, we embrace the motto "Viva La Différence," which signifies that we are stronger together, celebrating all identities across various dimensions of intersectionality. This principle underlies our organizational culture. We are committed to fostering a sense of belonging and creating equitable and inclusive experiences for all talent.

Publicis Groupe offers a comprehensive and inclusive benefits package to support the diverse and evolving needs of our workforce, enabling every individual to grow and thrive. Our benefits include medical coverage, dental and vision plans, disability insurance, a 401K plan, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

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