UnitedHealth Group

Sr. Regulatory Manager

UnitedHealth Group • $91K — $163K *
Westbury, NY 11590In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 3+ years of clinical trial regulatory affairs experience in healthcare
  • Experienced in preparing and submitting clinical trial applications and amendments
  • Worked on cross-functional clinical development teams
  • Expertise in clinical trial regulatory activities including start-up and close-out
  • Solid understanding of ICH and GCP guidelines
  • Proven management of regulatory timelines and submissions across studies
  • Excellent communication skills for authoring documents and working with health authorities

Responsibilities

  • Prepare FDA 1572 and distribute Financial Disclosure Forms
  • Maintain site study binders and regulatory documents
  • Communicate with study monitors and provide updated documents
  • Train on systems for confirming Investigational Product shipments
  • Attend remote monitoring and study close-out visits
  • Inventory and order central laboratory kits and supplies
  • Support Clinical Research Coordinators with submission tasks

Benefits

  • Comprehensive benefits package
  • Incentive and recognition programs
  • Equity stock purchase options
  • 401k contribution
  • Flexible work environments with clear career progression opportunities
Full Job Description
Optum NY/NJ, is seeking a Regulatory Manager to join our team in Westbury, NY.

Primary Responsibilities:

  • Study start-up:
    • Prepare FDA 1572 with Principal Investigator, sub-Investigator, medical research facility, and clinical laboratory information
    • Distribute, collect, and track Financial Disclosure Forms for signatures from Principal Investigator and sub-Investigators
    • Submit Regulatory and Laboratory Documents via email and Investigator Portal
    • Back-up for distribution and collection of study Delegation of Authority Logs and Training Logs for signatures from Principal Investigator, sub-Investigators, Clinical Research Coordinators, and staff
    • Back-up for preparation, submission and obtaining initial approval from Institutional Review Boards
    • Participate in Site Initiation Visits
  • Prepare and maintain site Study binders; distribute for signatures and collect updated FDA 1572, Financial Disclosure Forms, Delegation of Authority Logs, and Training Logs
  • Collect and maintain current CVs, Medical Licenses, and Good Clinical Practice certificates for PI and sub-Investigators
  • Prepare regulatory documents such as Protocol Signature Pages and Investigators' Brochures Acknowledgement of Receipts for Principal Investigator's signature
  • Collect and maintain updated local laboratory documents from all affiliated sites
  • Communicate with study monitors; supply updated study related documents as requested and answer questions regarding Regulatory documents
  • Train on Interactive Web Response Systems for confirming shipment of Investigational Product
  • Confirm shipment and inventory Investigational Product
  • Prepare Investigational Product for distribution to clinical sites according to Sponsor protocol
  • Back-up for study Continuing Review preparation, submission, and obtaining approval from Institutional Review Boards. Submission of changes in Research: change in PI, change in address, name, or the addition/removal of sites
  • Back-up for Delegation and Training Logs updating with addition/removal of site staff. Staff notification of updated Protocol Amendments, Informed Consents, Training requirements and Informed Consent signature requirements
  • Back-up for IP accountability, preparing Pharmacy Binder, and IP destruction for monitoring visits. Maintaining and recording daily temperatures
  • Attend remote monitoring visits and study Close Out Visits
  • Prepare, update, and distribute Patient Appointment Lists weekly to Optum Medical Care, PC Clinical Research Coordinators and staff
  • Request CT and MRI scans on discs from local radiology departments and upload for Radiologists' review; collect and distribute reports to Principal Investigator, Research Coordinators, and staff
  • Prepare, update, and distribute Protocol Flyers to Principal Investigator and sub-Investigators
  • Prepare Subject and Informed Consent binders
  • Inventory Central Laboratory Kits and Supplies; order as necessary
  • Support Clinical Research Coordinators via phone calls, emails, and text messages in the following:
    • Assist in the preparation of subject eligibility packets for submission to the Clinical Trial Sponsors
    • Distribute Investigational Product to clinical sites for study subjects
    • Prepare and distribute central laboratory kits for monthly subject visits
    • Process and submit central laboratory specimens according to Sponsor protocol
    • Request Archival Tumor Tissue from local laboratories and submit to central laboratories according to Sponsor protocol
    • Collect and distribute central laboratory reports to Optum Medical Care, PC Clinical Research Coordinators
    • Answer queries from central laboratories


You9ll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.

Required Qualifications:

  • 3+ years of experience in clinical trial regulatory affairs experience within healthcare industry
  • Experience preparing, reviewing, and submitting clinical trial applications, amendments, annual reports, and related regulatory documentation
  • Experience working on cross-functional clinical development teams
  • Demonstrated expertise in clinical trial regulatory activities - study start up, study maintenance and close out
  • Solid knowledge of ICH guidelines, GCP guidelines
  • Proven ability to manage regulatory timelines and coordinate submissions across multiple studies and regions
  • Excellent project management, organizational, and prioritization skills
  • Outstanding written and verbal communication skills, including authoring regulatory documents and interacting with health authorities
  • Ability to work independently while leading complex regulatory activities


Preferred Qualifications:

  • 5+ years of regulatory affairs experience
  • Experience with decentralized clinical trials
  • Knowledge of oncology clinical trials


Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you9ll find a far-reaching choice of benefits and incentives. The salary for this role will range from $91,700 - $163,700 annually based on full-time employment. We comply with all minimum wage laws as applicable.

About UnitedHealth Group

UnitedHealth Group is a medical facility. They offer health technology, health finance, and pharmacy services. They are utilizing clinical data and intelligence to assist in the redesign, automation, and deployment of technology to streamline administrative operations and clinical decision-making. Payment systems for both consumers and providers are critical components of a health-care system.

UnitedHealth Group Careers

Joining UnitedHealth Group means becoming part of a diverse team dedicated to making a difference. As a leader in health services and innovation, our company offers a variety of job opportunities that allow professionals to leverage their skills, drive innovation, and improve lives. Work You’ll Do At UnitedHealth Group, you’ll contribute to a mission-focused environment where your expertise will influence the health and well-being of people worldwide. Our employment opportunities span across a wide range of disciplines, from healthcare specialists to data analysts, ensuring that your career journey is both dynamic and rewarding. Transform Healthcare with Your Expertise UnitedHealth Group stands at the forefront of health innovation. Our team collaborates to deliver solutions that lead to better patient outcomes. Working with us, you’ll find yourself at the intersection of technology, healthcare, and leadership, providing key insights that drive industry transformation. Join Our Global Team As part of our team, you’ll engage with over 300,000 professionals globally, dedicated to building a diverse and inclusive workplace. UnitedHealth Group is not just a company; it’s a community where you can grow your career through continuous learning and leadership opportunities. Our commitment to diversity training ensures that every team member can thrive. UnitedHealth Group Career Development We are committed to your professional growth. Explore career paths filled with promising job opportunities and internships that will harness your potential and expand your capabilities. Whether you’re a seasoned professional or a recent graduate, you’ll find that our career development programs support your ambition at every level. Innovative Work Environment At UnitedHealth Group, innovation is at the core of our operations. We encourage our team to bring forward-thinking ideas that challenge the status quo and lead to breakthrough improvements in patient care. Be Part of a Great Team Our culture fosters a collaborative and supportive environment where every member’s contribution is valued. Enjoy the benefits of being part of a global team that’s committed to making a difference in people’s lives. Future-Proof Your Career With UnitedHealth Group, your career is future-proof. Dive into a range of positions that offer both challenges and rewards. Our robust support system includes unmatched training, development programs, and certification support to propel your career forward. Stay Connected Join Our Team Discover the right position that matches your skills and interests. We are always hiring and look for passionate, curious, and solution-driven team players. Search UnitedHealth Group jobs today and take the first step towards a fulfilling career. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights you can use today—all from the people who work here. Read Careers Blog Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Explore the exciting and rewarding opportunities that await at UnitedHealth Group.
Learn more about UnitedHealth Group
Size
350,000 employees
Market Cap
$493.1 billion
Industry
Healthcare
Net Income
$15.4 billion
Founded
1974
5 Year Trend
+9.2%
Revenue
$257.1 billion
NASDAQ
UNH
* Ladders Estimates

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