Senior Associate, Regulatory Review

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

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

Qualifications

SKILLS & EXPERIENCE:

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 Information

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.

About Publicis Health 

Publicis Health is the premier global health and wellness communications network. We are one of the four solutions hubs of Publicis Groupe, the third-largest advertising and media company in the world, giving us unparalleled global reach. We manage top-tier agencies specializing in promoting innovative solutions in advertising, medical education, clinical trial program development, sales and marketing, digital, market access, and medical and scientific affairs. Our nearly 6,500 employees work at 15 agency brands across 60 offices located in 10 countries. We are a connected solutions hub, equipped for continual business  
transformation in today’s world. We integrate services across our global offices and brands to deliver on our clients’ needs. Each of our agencies brings a unique approach to business, which makes us even s