Address
Form of workCompany Description
CoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people's lives by connecting real-time data with world-class creative, content, and media in service of growth and ROI.
CoLab is a "power of one" solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the energetic atmosphere of a startup company with the stability and experience of a global leader.
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:
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 Information
All your information will be kept confidential according to EEO guidelines.
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/
CoLab is a fully integrated, cross-discipline team that provides best-in-class services in a fluid and modular way. With our clients at the center, we create brand movement at the speed of people's lives by connecting real-time data with world-class creative, content, and media in service of growth and ROI.
CoLab is a "power of one" solution, encompassing data, media, and production. By drawing from across the vast Publicis Groupe network, we are uniquely positioned to deliver innovation and specialized skills to our clients, as well as enriching opportunities and inclusive benefits to our employees. We pride ourselves on combining the energetic atmosphere of a startup company with the stability and experience of a global leader.
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
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
All your information will be kept confidential according to EEO guidelines.
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/
