Job Information
Publicis Groupe Vice President, Director, Regulatory Review in Philadelphia, Pennsylvania
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
Job Description
Within Digitas Health, the Vice President, Director, Regulatory Review will provide advice to creative, strategy, planning, marketing, and other capabilities on the latest updates from FDA and other regulatory authorities. This includes evaluating creative concepts and prospective campaigns to identify potential obstacles to approval and helping teams develop strategies for overcoming those obstacles. You will responsible for ensuring the smooth daily operations of the team of employees who submit materials for regulatory review by Digitas Health's external clients.
The Vice President, Director, Regulatory Review supports teams with managing their clients' review processes including participation in client planning and presentations. Internally, you will also be responsible for process improvement throughout Digitas Health in guiding materials through review and ensuring awareness of changing regulatory environment.
This is a hybrid role, requiring three days in-office each week. If you are contacted for an interview, your recruiter will discuss specifics with you, inclusive of any necessary reasonable accommodations.
Your Impact:
Provide expertise on the latest FDA regulations and industry updates
Provide leadership, career guidance and training opportunities for the department staff
Manage multiple reports (direct or indirect) at the Director, Manager and Senior Associate level including responsibility for interviewing, hiring, onboarding, and career development
Work with staffing, recruiting, and individual business managers to determine workload projections to ensure all client needs are met
Work with external clients to establish appropriate regulatory review procedures where procedure has previously been lacking
Advise external clients on streamlining their process, the latest FDA regulations and industry updates
Work with new external clients to uncover and document their review procedures
Contribute to new business development efforts
Train DH personnel on FDA regulations and the MLR review process
Be a advocate for the Regulatory Review Department internally and in front of external clients
Qualifications
Minimum of a bachelor's degree and 4+ years of experience preparing complex deliverables under tight deadline constraints is required with at least 3 years of management experience.
Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous pharmaceutical industry or healthcare experience is required.
At least 3 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Perform other responsibilities as assigned.
#LI-Hybrid
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 hrcompliance_usms@publicis.com .
All your information will be kept confidential according to EEO guidelines.
