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

The 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.

DUTIES & 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

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.

The Power of One starts with our people!  To do powerful things, we offer powerful resources.  Our best-in-class wellness and benefits offerings include:

• Paid Family Care for parents and caregivers for 12 weeks or more
• Monetary assistance and support for Adoption, Surrogacy and Fertility
• Monetary assistance and support for pet adoption
• Employee Assistance Programs and Health/Wellness/Comfort reimbursements to help you invest in your future and work/life balance
• Tuition Assistance
• Paid time off that includes Flexible Time off Vacation, Annual Sick Days, Volunteer Days, Holiday and Identity days, and more
• Matching Gifts programs
• Flexible working arrangements
• ‘Work Your World’ Program encouraging employees to work from anywhere Publicis Groupe has an office for up to 6 weeks a year (based upon eligibility)
• Business Resource Groups that support multiple affinities and alliances

The benefits offerings listed are available to eligible U.S. Based employees, are reviewed on an annual basis, and are governed by the terms of the applicable plan documents.

Digitas Health is an Equal Opportunity Employer.  Our employment decisions are made without regard to actual or perceived race, color, ethnicity, religion, creed, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, childbirth and related medical conditions, national origin, ancestry, citizenship status, age, disability, medical condition as defined by applicable state law, genetic information, marital status, military service and veteran status, or any other characteristic protected by applicable federal, state or local laws and ordinances.

If you require accommodation or assistance with the application or onboarding process specifically, please contact [email protected].

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

Compensation Range:  $51,000 - $75,000 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. For this role, 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 6/1/2024.