Regulatory Operations Specialist

Agency:

Biolumina

Job Function:

Production

Job Subfunction:

Production Operations

Job Description:

Title: Regulatory Operations Specialist 

Company: Omnicom Health 
Manager: Alex Polk

Schedule: 9:00 AM – 6:00 PM EST 

 

The Regulatory Operations Specialist 's main responsibility is to manage regulatory submissions and associated tasks for 1-3 client brands, while adhering to industry standards and agency- and client-established processes. The Specialist will partner with agency brand teams to help prepare and upload submission materials into client submission portals. This role requires excellent planning, problem-solving, organizational, written, and verbal communication skills to ensure accuracy and efficiency of submissions, as well as the ability to work in a fast-paced, deadline-driven environment. The Specialist must be a critical thinker and be able to learn new systems and processes for the agency and their assigned client brands. Proficiency in Excel, Word, PowerPoint, Outlook, and TEAMS required. You will be responsible for managing and overseeing end-to-end content submission processes while ensuring submissions are timely, accurate, and compliant with the given Brand/AMA guidelines. 

 

This role requires effective collaboration with cross-functional teams to facilitate seamless submission processes and address any content-related queries. 

 

Role Responsibilities: 

 

·       Expertly manage the tagging and linking of references cited in promotional materials within client submission systems. 

·       Collaborate with editors, medical writers, and project managers to manage timelines, resolve queries, and address reviewer feedback.  

·       Successfully manage day-to-day workload for 1-3 client brands. 

·       Stay up to date on the latest standard operating procedures for each assigned client brand. 

·       Prioritize workload to meet each client's deadline successfully. 

·       Communicate clearly and effectively with appropriate agency team members about status, requirements, and challenges when working on submissions. 

·       Maintain updated trackers and assist with updating client brand process decks. 

·       Communicate changes in processes to the extended internal teams. 

·       Attend agency team meetings for assigned client brands. 

·       Comply with agency administrative processes and ways of working. 

·       Upload clean, properly named documents, and annotated pieces with appropriate references. 

·       Open placeholders for submissions as required by the client process. Flag missing information (metadata) to the account team, where applicable 

·       Responsible for resubmissions, final submissions, validation, functional annotations, etc., as specified by the assigned client brands regulatory process needs. 

·       Upload relevant supporting documents to accompany submissions. 

·       Link tactics to relevant component assets as per the assigned client brand’s regulatory process 

·       Track status of submitted tactics in the MLR portal. 

·       Download MLR comments from the submission portal and share with Account Services, Project Management, and Copy  

·       Upload references and assets to the submission portal for approval.  

·       Identify process gaps, suggest improvements, and support workflow optimization to enhance submission efficiency.      

·       Uphold the highest quality standards by ensuring error-free submissions and strict compliance with editorial and regulatory guidelines. 

·       Provide guidance and mentorship to junior submission specialists to improve process understanding and skill development. 

·       Stay ahead of industry trends by actively participating in product status meetings and leveraging expertise to improve editorial workflows.        

 

 

Your Day-to-Day Deliverables will include: 

 

·       Manage content submissions, ensuring accuracy and compliance with submission standards. 

·       Oversee the complete asset lifecycle on Veeva PromoMats, ensuring proper organization and version control. 

·       Proactively enhance submission workflows and collaborate with internal and external stakeholders. 

·       Ensure adherence to the AMA Style Guide and brand guidelines in all submissions. 

·       Track, document, and maintain digital asset management (DAM) systems, troubleshooting and resolving issues efficiently. 

#LI-AV1

$48,000 - $60,000 

To the extent permissible by local law, 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.

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