Manager, Regulatory Operations (Freelance)

Publicis Groupe • Philadelphia, PA • 3h ago

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 Manager, Regulatory Operations is a subject matter expert specializing in the preparation of promotional materials to be submitted to our pharmaceutical clients' Medical, Legal, Regulatory (MLR) review in accordance with both client specific standards and requirements as well as internal guidelines. The Manager is responsible for tracking the progress of each project through the various stages of the MLR review process, as well as advising on submission timelines and resource requirements to ensure that the team is able to meet all submission deadlines. The Manager is also responsible for the delegation of projects across a team of direct and/or indirect reports at the Associate and Senior Associate levels. The Manager plays a key role in establishing procedures for internal teams, as well as advising on specific projects to aid a smooth and fast review by client teams.

Responsibilities

DUTIES & RESPONSIBILITIES:

Create and/or oversee the creation of the submissions and ensure they conform to both internal guidelines as well as client specific requirements.

Manage one or more direct reports at the Associate and Senior Associate level, including responsibility for interviewing, hiring, onboarding, training, and career development.

Determine the time and effort required to complete each submission.

Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines.

Follow up 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.

Advise Project Management team on submission timelines & resource requirements.

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.

Oversee work of reporting employee(s) on daily basis, providing advice on projects, and helping to address problems as they arise.

Qualifications

SKILLS & EXPERIENCE:

Required

Minimum of a bachelor's degree and 4-6 years of experience in the preparation of complex submission deliverables under tight deadline constraints

Commitment to leading by example

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 at least 1 direct report

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 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 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: $31.79 - $43.92 hourly. 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 06/04/2026.

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

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