Senior Manager, Regulatory Operations

Company Description

Digitas Health is the Agency of Now: the first global connected-health agency, purpose-built for marketing today. Digitas Health specializes in helping health brands navigate a complex and shifting media environment to create deeper, more relevant connections with their consumer and professional customers. With offices in Philadelphia, New York, San Francisco, and London, it is a member of the world's largest healthcare communications network,

Publicis Health. As a member of this elite network, Digitas Health is also a member of the Paris-based Publicis Groupe S.A. (Euronext Paris: FR0000130577), the world's third-largest communications group, second-largest media counsel and buying group, and a leader in digital communications.

Web: www.digitashealth.com | Facebook: www.facebook.com/digitashealth| Twitter: www.twitter.com/digitas_health

Overview

The Senior Manager, Regulatory Promotional Operations is responsible for managing a team of Associates, Senior Associates, and Managers to ensure promotional materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for Medical, Legal, Regulatory (MLR) review.

The Senior Manager plays a key role in establishing procedures for internal teams and advising on specific projects to aid smooth and fast review by clients. The Senior Manager is responsible for identifying and solving potential issues across their account(s). Additionally, the Senior Manager is responsible for the delegation of projects across a team of direct and/or indirect reports for their assigned brands to ensure the team is able to meet all deadlines.

Responsibilities

• Create and/or oversee the creation of the components and ensure they conform to client and Digitals Health guidelines
• Manage multiple direct reports at the Associate, Senior Associate, and Manager level, including responsibility for interviewing, hiring, onboarding, training, and career development.
• Coordinate delegation of work among reporting staff to manage workflow across an account. Ensure appropriate resources are available to meet client demands.
• Provide oversight to work of reporting employees on daily basis. Offer advice on projects, act as a resource to assist with problem solving as needed, and simultaneously manage projects directly.
• Provide estimates for SOW development.
• Advise Project Management team on submission timelines & resource requirements.
• Work with the VP, Regulatory Promotional Operations in the development of departmental SOPs.
• Create, update, and disseminate to department/team documentation on client specific guidelines.
• Actively manage team expectations; directly interface with clients as required.
• Establish procedures to optimize and improve the submission process.
• Develop a rapport with client MLR liaison, acting as the primary point of contact.
• Work closely with client MLR liaison to ensure all submissions are received on time and meet all client expectations and specifications.
• Collaborate with client MLR liaison to offer recommendations on best practices and drive process forward.
• Partner with other capability leads to constantly improve and refine internal processes and put forth the best work possible.
• Oversee work of reporting employees on daily basis, providing advice on projects, and helping to address problems as they arise.

Qualifications

Required

• Minimum of a bachelor's degree and 5-8 years of experience in the preparation of complex submission deliverables under tight deadline constraints
• Courageous leadership skills
• Technical competency in Adobe Acrobat and the Microsoft Office Suite
• Experience communicating with clients directly
• Clear communication and attention to detail
• Top notch organizational skills
• Experience managing diverse direct reports with a personal interest in growing talent
• At least one year of experience in Pharmaceutical Industry, Healthcare, or similar environment

Preferred

• Agency and/or project management experience
• Experience working on cross-functional teams
• Clear, concise technical writing ability
• Working knowledge of Adobe InDesign and Photoshop

Desirable

• Experience working in content management systems such as Veeva Vault
• Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience

Additional Information

Our Publicis Groupe motto "Viva La Diffrence" 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 to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

If you require accommodation or assistance with the application or onboarding process specifically, please contact USMSTACompliance@publicis.com.

Compensation Range: $79,990 - $125,925 annually. This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time. Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. Temporary roles may also qualify for participation in our 401(k) plan after eligibility criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off. The Company anticipates the application deadline for this job posting will be 05/24/2025.

All your information will be kept confidential according to EEO guidelines.

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