Manager, Regulatory Promotional Operations

Company Description

CoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people's lives by connecting real-time data with world-class creative, content, and media in service of growth and Return on investment.

CoLab is a "power of one" solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the atmosphere of a startup company with the stability and experience of a global leader.

Job Description

The Manager, Regulatory Promotional Operations, is a subject matter expert specializing in the preparation and delivery of submission packages for promotional materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a brand lead, the Manager is responsible for tracking the progress of each project through the various stages of the MLR review process. The Manager provides expert guidance on submission timelines and resource requirements to ensure all submission deadlines are met. Additionally, the Manager is responsible for delegating projects across a team of direct and/or indirect reports, including Associates and Senior Associates.

The Manager plays a critical role in establishing and refining procedures for internal teams and advising on specific projects to facilitate a smooth and efficient review process. Their expertise and leadership are essential in driving the success of the submission process and ensuring compliance with client-specific and regulatory requirements.

DUTIES & RESPONSIBILITIES:

• Act as a brand lead, overseeing the submission process and ensuring alignment with client expectations and regulatory requirements.
• Independently prepare and deliver high-quality submission packages through taking screenshots, organizing materials to output a compliant submission PDF, and annotating pertinent information.
• Assess the time and effort required to complete each submission and partner with Project Management team to develop submission timelines and allocate resource accordingly.
• Maintain a comprehensive and accurate dashboard of all current and upcoming submissions, including the stage of review and submission deadline.
• Follow up directly with client liaisons to ensure submissions are received on time and meet all client expectations and specifications.
• Create, update, and disseminate to department/team documentation on client specific guidelines.
• Actively manage team expectations; directly interface with clients as required.
• Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage.
• Manage one or more direct reports at the Associate and Senior Associate level, including responsibility for interviewing, hiring, onboarding, training, and career development.
• Oversee work of reporting employee(s) on daily basis, providing advice on projects, and helping to address problems as they arise.

Qualifications

Required

• Bachelor’s degree in a relevant field and 3-4 years relevant experience preparing complex submission deliverables under tight deadlines.

• Technical competency in Adobe Acrobat Pro DC and Microsoft Office Suite.
• Proficiency in Veeva Vault PromoMats.
• Meticulous attention to detail.
• Superior organizational skills and ability to effectively manage multiple tasks efficiently.
• Exceptional communication skills and experience communicating with clients directly.
• Commitment to leading by example.

Preferred

• Agency and/or project management experience.
• Proven experience working within cross-functional teams.
• Clear, concise technical writing ability.
• Experience managing at least one direct report.
• Working knowledge of Adobe InDesign and Photoshop.

Desirable

• Demonstrated knowledge of FDA regulations for promotional materials, gained through appropriate training or previous experience.

Additional Information

Our Publicis Groupe motto "Viva La Différence" means we're better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.

Publicis Groupe provides robust and inclusive benefit programs and policies