Associate, Regulatory Operations

Associate, Regulatory Operations

19 Nov 2024
New York, New york city 00000 New york city USA

Associate, Regulatory Operations

Company DescriptionCoLab 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.OverviewThe Associate, Regulatory Promotional Operations, plays a crucial role in supporting the preparation and delivery of submission packages for promotional materials to be reviewed through the client Medica, Legal, Regulatory (MLR) process. The Associate maintains a strong working knowledge of the client-specific guidelines and requirements for submission, as well as the tools utilized to manage the MLR process. The Associate tracks projects through the MLR process and facilitates effective communication among team members regarding project statuses.Responsibilities

Support the preparation and delivering high-quality submission packages through taking screenshots, organizing materials to output a compliant submission PDF, and annotating pertinent information.

Ensure compliance with client-specific guidelines and internal requirements.

Route submission materials to internal team and implement revisions as needed.

Facilitate communication within the team to track project statuses.

Link references in client system (Veeva Vault PromoMats) and attach any ancillary documentation.

Retrieve MLR comments from client system and determine next steps in MLR process.

Comfortably balance multiple assignments simultaneously.

Directly communicate in a clear and concise manner with internal stakeholders.

Assist in maintaining departmental archive.

QualificationsRequired

Bachelor’s degree in a relevant field.

Technical competency in Adobe Acrobat Pro DC and Microsoft Office Suite.

Exceptional communication skills.

Meticulous attention to detail.

Superior organizational skills and ability to effectively manage multiple tasks.

Preferred

Experience in Veeva Vault PromoMats.

Experience preparing complex submission deliverables under tight deadlines.

Strong technical writing skills, with the ability to produce clear and concise documentation.

Previous internship, co-op, or professional experience in a related field.

Desirable

Experience in the pharmaceutical industry, healthcare, or a similar regulatory environment.

Agency and/or project management experience.

Proven experience working within cross-functional teams.

Working knowledge of Adobe InDesign and Photoshop.

Additional InformationOur Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.If you require accommodation or assistance with the application or onboarding process specifically, please contact USMSTACompliance@publicis.com. All your information will be kept confidential according to EEO guidelines.Compensation Range: $35,000 - $52,000 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 01/19/2025.

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