Freelance Senior Regulatory Affairs Specialist

4+ years

Not Disclosed

Princeton Junction

15 June 20, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About the job

Job Title: Freelance Senior Regulatory Operations Specialist

About this role:

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.

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 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

Requirements:

4+ years of experience in a relatable role preferred
Familiarity with agency submission process and MLR preferred
Must be familiar with FUSE
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, FUSE, Zinc, and web based applications)
MS Office experience and competence required
Workload management and people supervisory experience a plus

About MRM

MRM is a modern relationship marketing agency that delivers transformative creative solutions at the intersection of business, culture, and technology. MRM operates in a borderless, integrated way, to allow for greater collaboration and velocity—all to the service of helping businesses grow meaningful relationships with people. MRM is part of McCann Worldgroup and the Interpublic Group of companies (NYSE: IPG), and spans 35 offices across North America, Latin America, Europe, the Middle East, and Asia Pacific. For more information, please visit www.mrm.com.

We love our diverse workplace! MRM is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status or any other occupationally irrelevant criteria.

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Freelance Senior Regulatory Affairs Specialist

Job Description

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