Senior Regulatory Operations Specialist

MRM McCann; New York (NY); On-site; USD 80,000 - 90,000; Full time

Job summary

Omnicom Precision Marketing in New York City is seeking a submissions lead in Production Operations to manage day-to-day submissions, coordinate with PM, and ensure MLR compliance across materials. The role requires strong organization, problem-solving, and stakeholder communication to keep multiple campaigns on track.

Candidates should have 4+ years' related experience, MS Office proficiency, and familiarity with regulatory submission processes.

Qualifications

• 4+ years of related experience
• Familiarity with agency submission process and MLR
• Strong interpersonal and problem-solving skills; ability to engage senior personnel
• Ability to manage multiple projects as one cohesive program
• Capacity for risk identification and management
• Ownership of process and results
• Strong writing and verbal communication
• Highly organized and detail oriented with influencing others
• Creative solutions to complex problems and multitasking
• Comfort with electronic docbases, databases, and MS Office, Veeva Vault, Zinc

Responsibilities

• Serve as day-to-day submissions lead; manage workload to team members
• Ensure submission timelines; gather material for accurate submissions
• Cross-functional work with Project Management to meet deadlines
• Learn and navigate client-based submission systems for efficient use
• Maintain reference and asset libraries for internal use
• Initiate submission processes and track from kickoff to final submission
• Organize submission materials per client requirements and ensure MLR compliance
• Submit materials via Client MLR submission platform
• Provide status updates on submission progress
• Record keeping and knowledge base: maintain project tracker
• Document current client requirements for MLR submissions

Skills

Interpersonal skills

Problem solving

Multitasking / project management

Risk identification & management

Ownership of process & results

Written & verbal communication

Organized & detail oriented

Influence others

Creative problem solving

MS Office proficiency

Tools

MS Office

Veeva Vault

Zinc

Web-based applications

Job description

Agency:

Omnicom Precision Marketing

Job Function:

Production

Job Subfunction:

Production Operations

Job Description:

MRM is part of theOmnicomPrecision Marketing activation practice.This practice integrates CRM platform expertise, journey management, and first-party data capabilities with creative excellence and performance capabilities, enablingOmnicomto 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 visitwww.mrm.com.

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+ years of 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.