Company DescriptionDigitas 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/digitashealthOverviewThe Manager, Regulatory Review is responsible for managing a team of Associates and Senior Associates to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review. The Manager plays a key role in establishing procedures for internal teams and advising on specific projects to aid smooth and fast review by clients.Additionally the Manager, Regulatory Review must traffic, manage and assign all work flowing through their assigned brands to ensure the team is able to meet all deadlines.Responsibilities
Manage multiple direct reports at the Associate, Senior Associate, and Manager level including responsibility for interviewing, hiring, onboarding, training, and career development
Provide estimates for SOW development
Work with the Director, Regulatory Review in the development of departmental SOPs
Oversee work of reporting employees on daily basis, providing advice on projects, and helping to address problems as they arise
Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage
Determine the time and effort required to complete each submission
Establish a timeline and assign responsibility to the appropriate team members for the delivery of the components of the submission
Create and/or oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
Follow up with client liaison in a timely manner to ensure the submission is received on time and meets 100% of client expectations and specifications
Create, update, and disseminate to the rest of the department procedure(s) specific to the clients supported
Qualifications
Minimum of a bachelor's degree and 4-6 years of experience in the preparation of complex deliverables under tight deadline constraints is required.
Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
Experience communicating with clients directly is required.
Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience is preferred.
Clear communication and attention to detail are essential.
Clear, concise technical writing ability is strongly preferred.
At least one year of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
Additional InformationOur 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.All your information will be kept confidential according to EEO guidelines.
