Senior Associate, Regulatory Operations

Company 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 Return on investment.  

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 atmosphere of a startup company with the stability and experience of a global leader.

Job Description

The Senior Associate, Regulatory Operations 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 Publicis 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.

Additional Information

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

Compensation Range: $24.52- $36.06/hr. 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. This role may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. This role may also qualify for participation in our 401(k) plan after eligibility criteria have been met. The Company anticipates the application deadline for this job posting will be 10/02/2024.