Senior Regulatory Operations Specialist

Omnicom Precision Marketing; New York (NY); On-site; USD 80,000 - 90,000; Full time

Job summary

Omnicom Precision Marketing in New York City seeks a Senior Regulatory Operations Specialist to manage regulatory submissions across Client Medical, Legal and Regulatory groups. You will lead day-to-day submissions, build strong client and internal relationships, and ensure on-time, compliant packages across brands.

The role requires 4+ years of relevant experience, familiarity with MLR processes, and strong writing and organizational skills.

Qualifications

• 4+ years of experience in a relatable role preferred.
• Familiarity with agency submission process and MLR preferred.
• Strong writing and verbal skills; highly organized and detail oriented.
• Workload management and people supervisory experience a plus.

Responsibilities

• Serve as day-to-day submissions lead; manage and filter workload to team members
• Demonstrate general knowledge of Regulatory Affairs and guidelines that govern advertising and promotional material according to FDA
• Work cross functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions
• Learn client-based submission systems and be able to navigate for efficient use, including the tagging and linking of references based on annotations provided by Copy team
• Maintain reference library and asset library for internal cross-functional use
• Execute submissions in the following manner: Initiate the submission process; Track the project from kickoff through to final submission Client MLR approval; Organize submission materials in accordance with Client dictated requirements; Ensure integrity of submission materials to ensure adherence with Client MLR requirements; Submit materials via Client MLR submission platform/tool; Provide status updates on submission progresses; Support team with prepping and sending final samples, and 2253 materials when needed; Record keeping and knowledge base: Document and maintain project tracker; Document and maintain current Client requirements for MLR submission; Maintain knowledge of the Client MLR schedule; Utilize and maintain regulatory document control and appropriate distribution of regulatory documents.

Skills

Interpersonal skills

Problem-solving

Written & verbal communication

Organizational skills

MS Office proficiency

Multi-tasking

Cross-functional collaboration

Tools

Veeva Vault

Zinc

Web-based applications

Regulatory systems

Job description

Job Description MRM is part of the Omnicom Precision Marketing activation practice. This practice integrates CRM platform expertise, journey management, and first-party data capabilities with creative excellence and performance capabilities, enabling Omnicom to deliver intelligent activation across the full funnel with data-driven decisioning at scale to help clients move faster and deliver more connected customer experiences.

Agency

Omnicom Precision Marketing

Job Function

Production

Job Subfunction

Production Operations

Job Description

MRM is part of the Omnicom Precision Marketing activation practice. This practice integrates CRM platform expertise, journey management, and first-party data capabilities with creative excellence and performance capabilities, enabling Omnicom to deliver intelligent activation across the full funnel with data-driven decisioning at scale to help clients move faster and deliver more connected customer experiences. MRM is a modern relationship marketing agency dedicated to building enduring brand relationships. MRM's specialized capabilities drive relationship lifetime value and span CRM, Customer Experience, and Commerce with data and martech at the core. MRM operates in a borderless, integrated way to enable greater collaboration, creativity, and true speed to market. For more information, please visit www.mrm.com. The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) groups. This position will support the Princeton pharmaceutical/health Client base. The Senior Regulatory Operations Specialist will manage submission workflow and capacity for specific brands and work to achieve expert level status on Client regulatory submission, collaboration, and archive platforms/tools. This includes a supporting role in adhering to and maintaining processes and requirements for the capability.

In This Role, You Will

• Serve as day-to-day submissions lead; manage and filter workload to team members
• Demonstrate general knowledge of Regulatory Affairs and guidelines that govern advertising and promotional material according to FDA
• Work cross functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions
• Learn client-based submission systems and be able to navigate for efficient use, including the tagging and linking of references based on annotations provided by Copy team
• Maintain reference library and asset library for internal cross-functional use
• Execute submissions in the following manner:
• Initiate the submission process
• Track the project from kickoff through to final submission Client MLR approval
• Organize submission materials in accordance with the Client dictated requirements
• Ensure integrity of submission materials to ensure adherence with Client MLR requirements
• Submit materials via Client MLR submission platform/tool
• Provide status updates on submission progresses
• Support team with prepping and sending final samples, and 2253 materials when needed
• Record keeping and knowledge base:
• Document and maintain project tracker
• Document and maintain current Client requirements for MLR submission
• Maintain knowledge of the Client MLR schedule
• Utilize and maintain regulatory document control and appropriate distribution of regulatory documents

What We Are Looking For

• 4+ yearsof experience in a relatable role preferred
• Familiarity with agency submission process and MLR preferred
• Must have strong interpersonal and problem-solving skills; be able to build strong relationships within the agency and client organizations, and must be able to participate in client and internal agency meetings with senior personnel
• Must be able to manage multiple projects as one cohesive program
• Capacity for risk identification and management
• Strong sense of ownership of process and results
• Strong writing and verbal skills
• Highly organized and detail oriented with an ability to influence others in these areas
• Ability to find creative solutions to complex problems and multi-task
• Must be comfortable working in an environment that utilizes electronic docbases, databases, and computer systems (Microsoft Office, Veeva Vault, Zinc, and web-based applications)
• MS Office experience and competence required
• Workload management and people supervisory experience a plus

This role will be based in New York City. The salary range for this position is $80,000 to $90,000. Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; the associated discipline; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee’s/applicant’s background, pertinent experience, and qualifications.

$80,000-$90,000

Omnicom’s policy requires employees to work in the office for a minimum of three days a week, unless additional in-office days are directed by their agency or manager. Our objective is to increase this requirement over time, and many of our agencies as well as Omnicom’s corporate group already require five days of in-office attendance.

Omnicom is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you. We will process your personal data in accordance with our Recruitment Privacy Notice.

Link to Recruitment Privacy Notice: https://www.omc.com/privacy-notice

For US Job Seekers

It is the policy of Omnicom and any of its affiliates to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law. EOE/AA/M/D/V/F.

$80,000-$90,000