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 Senior Associate, Regulatory Review must follow the protocol established by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the Medical-Legal-Regulatory (MLR) review board (a board of experts typically consisting of medical doctors, lawyers and experts in FDA regulations), submitting materials to the client (both electronically and/or in hard copy as determined by the clients' specifications), and tracking the progress of each project through the various stages of MLR review.Responsibilities
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
Act as the primary point of contact between the agency and the clients' MLR Review department, both to get information regarding submissions requirements and to answer procedural questions that arise during the MLR review process
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 2-4 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.
Clear communication and attention to detail are essential.
Clear, concise technical writing ability is strongly preferred.
Experience in Pharmaceutical Industry or Healthcare is preferred.
Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Performs other duties (or functions) as assigned.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.