Senior Regulatory Operations Manager
1 week ago
Company Overview:
Publicis Health is a comprehensive, multi-disciplinary organization that delivers exceptional services in a dynamic and adaptable manner. Our client-centric approach enables us to drive brand engagement at the pace of modern life by integrating real-time insights with top-tier creative, content, and media solutions to foster growth and maximize return on investment.
As a unified solution, Publicis Health combines data, media, and production capabilities. Leveraging the extensive resources of the 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 team members. We pride ourselves on merging the innovative spirit of a startup with the reliability and experience of a global leader.
Position Summary:The Senior Manager, Regulatory Promotional Operations is tasked with overseeing a substantial team of Associates, Senior Associates, and Managers to guarantee that marketing materials for assigned clients adhere to the regulatory protocols established by our pharmaceutical partners. This role is crucial in formulating internal procedures and providing guidance on specific projects to facilitate efficient and timely reviews by clients. The Senior Manager is also responsible for identifying and addressing potential challenges across their accounts.
In addition, the Senior Manager, Regulatory Promotional Operations must effectively manage and allocate all tasks flowing through their designated brands to ensure the team meets all 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 workflow among team members to ensure adequate coverage for all client requirements, including vacation management.
- Assess the time and resources needed for each submission.
- Establish timelines and assign responsibilities to 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 point of contact with the client’s Medical, Legal, and Regulatory (MLR) liaison.
- Follow up with the client liaison promptly to ensure submissions are received on time and meet all client expectations and specifications.
- Create, update, and distribute procedures specific to the clients supported.
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. Demonstrated knowledge of FDA pharmaceutical advertising regulations through relevant training or prior experience is preferred. Strong communication skills and attention to detail are critical. Clear and concise technical writing abilities are highly desirable. At least one year of experience in the Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
Additional Information:Publicis Groupe is committed to fostering an inclusive environment that celebrates diversity and promotes belonging. We offer comprehensive and inclusive benefits programs to support the diverse needs of our talent, enabling every individual to thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.
All information will be kept confidential according to EEO guidelines.
Compensation Range: $73,500 - $123,500 annually. This range reflects the company’s anticipated pay for this position at the time of posting. Compensation will be determined based on the applicant's skills, qualifications, and experience, as well as the position's requirements. The company reserves the right to modify this pay range at any time.
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