Associate Director Regulatory Affairs - Remote

Lensa; Minnetonka (MN); Remote; USD 106,000 - 195,000; Full time

Job summary

A leading health care company seeks an Associate Director of Regulatory Affairs. This strategic role involves developing research integrity policies and collaborating with various teams to ensure compliance. The position offers remote flexibility and opportunities for professional growth.

Benefits

Comprehensive health coverage

Incentives

Stock purchase options

401k plans

Qualifications

• 5+ years of experience in human research regulatory affairs.
• Deep knowledge of federal regulations related to IRB and clinical research.

Responsibilities

• Support the VP and Director of Human Research Affairs.
• Engage with leadership to tailor ethics and integrity solutions.
• Collaborate with Legal, Compliance, and Regulatory teams.

Skills

Communication

Problem Solving

Analytical Skills

Job description

Associate Director Regulatory Affairs - Remote

2 days ago | Be among the first 25 applicants

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Lensa is the leading career site for job seekers at every stage of their career. Our client, UnitedHealth Group, is seeking professionals. Apply via Lensa today!

UnitedHealth Group is a health care and well-being company dedicated to improving health outcomes worldwide. We consist of two main businesses, UnitedHealthcare and Optum, working to build a better health system for all. Your contributions here will help transform health care for years to come. Join a diverse team that shares your passion for helping others and start Caring. Connecting. Growing together.

This position is a strategic leadership role within the organization’s emerging centralized research ethics and integrity program. As Associate Director of Research Integrity, you will help develop enterprise-wide research integrity policies and procedures.

You will play a key role in expanding support for research sites and investigators, increasing internal research capabilities, and implementing strategies to ensure a consistently ethical and compliant research environment.

This role offers the flexibility to work remotely from anywhere in the U.S., applying your problem-solving skills to unique challenges.

Primary Responsibilities

• Support the VP and Director of Human Research Affairs in establishing a centralized Research Ethics and Integrity review program.
• Contribute to designing and implementing an electronic research oversight submission system.
• Engage with leadership across UnitedHealth Care, Optum, and affiliates to understand researcher needs and tailor ethics and integrity solutions accordingly.
• Collaborate with Legal, Compliance, and Regulatory teams to develop research policies and best practices.
• Assist with screening IRB submissions for completeness and compliance.
• Provide consultation to study teams to ensure ethical design and human participant protection.
• Maintain a research pipeline and track research activities.
• Stay updated on regulatory and technological research trends.
• Enhance your skills through professional development, certifications, and networking.

You will be recognized and rewarded for your performance in a challenging environment that offers clear success criteria and growth opportunities.

Required Qualifications

• 5+ years of experience in human research regulatory affairs and research protection regulations.
• Experience with research integrity compliance and oversight.
• Deep knowledge of federal regulations related to IRB and clinical research (e.g., Common Rule, Belmont Report, Helsinki Declaration, FDA, HIPAA, ICH, GCP).
• Attention to detail and ability to handle confidential information.
• Excellent communication, problem-solving, and analytical skills for technical discussions and correspondence.
• Ability to analyze technical information from various sources and incorporate it into processes.

Preferred Qualifications

• Leadership experience.
• Adherence to UnitedHealth Group’s Telecommuter Policy for remote employees.

The salary range is $106,800 to $194,200 annually, based on experience, location, and other factors. Benefits include comprehensive health coverage, incentives, stock purchase options, and 401k plans. Benefits are subject to eligibility.

Application Deadline: Posted for at least 2 business days or until sufficient candidates are found. The posting may close early if volume is high.

Our mission is to help people live healthier lives and improve the health system for everyone. We are committed to equity, environmental responsibility, and addressing health disparities, especially among marginalized groups.

UnitedHealth Group is an Equal Opportunity Employer and a drug-free workplace. Candidates must pass a drug test before employment.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Legal
• Industries: IT Services and IT Consulting

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