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Regulatory Operations Manager

New York, New York, United States

Remote/Hybrid 

Regulatory Operations Manager

Job Description

About Us

Virgo Health works for pharmaceutical, biotech, and device companies to inform and educate healthcare professionals about the latest developments in clinical research and therapeutic approaches. We leverage our meetings, digital, and interactive expertise to understand what’s easy and relevant for healthcare professionals to engage with. We tailor our content and design it to offer choice and active participation. Real, relevant, and human.

Job Overview

The regulatory operations manager oversees and supports the medical/legal/regulatory submission of high-quality medical education materials for multiple brands.

Core Responsibilities

• Work with brand teams to prepare and submit completed digital and print creatives for medical/legal/regulatory (MLR) submissions
• Train and supervise junior staff members
• Establish and cultivate relationships with MLR counterparts to discuss submissions, MLR reviews, and any relevant updates
• Enforce industry standards for all MLR submissions per FDA/OPDP regulations and per Virgo Health and pharmaceutical client specifications
• Tag and link references in Veeva Vault and other client-specific systems for multiple brands
• Schedule and manage weekly or daily submission status meetings for multiple brands
• Establish and maintain an archiving system that tracks and records all submission files and final materials
• Request access to submission system for Virgo team members and maintain training records
• Communicate with teams and clients to resolve questions regarding submissions

Team Working

• Excellent communication skills
• Is an integral member of the team, contributes to meetings, flags priorities, and helps drive deadlines

Project Management

• Plans workload and proactively highlights resource gaps and recommends solutions
• Works within agreed deadlines and budgeted hours to complete projects

Experience/Skills Required

• Excellent attention to detail
• Ability to multitask
• Excellent verbal and written communication skills
• Ability to prioritize and work under pressure
• Some familiarity with medical terminology and AMA style
• Strong planning and organization skills
• Experience with Veeva Vault
• Understanding of the MLR process and advanced knowledge of the annotating/referencing process
• Proficient with Microsoft Office and Adobe Acrobat (project planning software a plus)
• Competency in current and relevant computer-related technologies and applications
• Efficient, self-starter, quick study, flexible, and willing to evolve in this newly established role; committed to the integrity of each project

Level of Experience

• 3 years of experience at a healthcare communications agency, pharmaceutical advertising agency, or another highly regulated industry a plus

Qualification

• Bachelor’s degree

Virgo Characteristics

• Team player
• Passionate commitment
• Professionalism and client focus
• Open communication
• Self-development
• Detail focus
• Organization
• Embraces change

Key Performance Indicators

• Annual performance objectives and performance appraisal
• Quality of submitted materials

Salary Range: $70,000-$115,000

Actual compensation offered within the range will depend upon, among other factors: a candidate’s skills, qualifications, and experience; actual ranges for current or former employees in the role; and market considerations.

Virgo is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status