- Publicis Worldwide
1103 Market St
About Digitas Health
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: FR000#######), 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 Manager, Regulatory Review is responsible for managing a large team of Associates, Senior Associates, and Managers to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review. The Senior Manager plays a key role in establishing procedures for internal teams and advising on specific projects to aid smooth and fast review by clients. The Senior Manager is responsible for identifying and solving potential issues across their account(s).
Additionally the Senior 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.
DUTIES & 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 a 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
* Establish and manage role as a primary point of contact with client MLR liaison
* 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
SKILLS & EXPERIENCE:
* Minimum of a bachelor's degree and 5-8 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.
* At least one year of experience in the Pharmaceutical Industry, Healthcare, or Advertising Agency is required.
* Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience is preferred
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 stronger together. We understand the rapidly changing healthcare environment and leverage it to maximize the potential of our clients' brands.
Web: www.publicishealth.com - Facebook: www.facebook.com/publicishealth
Twitter: www.twitter.com/PublicisHealth/* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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