Regulatory Manager

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Our client, a leading non-profit healthcare system in New Jersey, is looking to add a Regulatory Manager to oversee the cancer research team and ensure clinical trials are compliant with business standards and Federal regulations. This individual will oversee direct reports and act as a POC between team members, investigators, and other vendors.

This Role Offers:

• Competitive wage plus great benefits – medical/dental/vision, 401(k) match, etc.
• A company viewed as leader in healthcare humanitarianism, taking pride in serving those in need.
• Opportunities for top-tier learning programs that inspire, connect, and develop their team.
• Culture of high performance and quality customer care.
• Work to provide the motivation, tools, steps, and community that will produce lasting outcomes.
• High level of involvement in cutting edge clinical research that is set to change the way healthcare providers approach and care for cancer.

Focus:

• Lead the team throughout regulatory clinical trials, managing, coaching, and mentoring staff.
• Perform internal audits to evaluate clinical trial conduct and ensure trials are properly maintained and that regulatory files and processes are up to date.
• Prepare and submit documents related to the regulatory review to the relevant scientific review groups for new protocol applications, amendments, deviations/violations, and continuing reviews.
• Maintain medical laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance.
• Implement new programs, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress.
• Follow all Standard Operating Procedures to ensure safety and quality standards.
• Stay up to date on changes to GCP, clinical, and federal requirements along with recommending actions required to maintain compliance.

Skill Set:

• 5+ years of cancer research quality control experience in the healthcare or pharmaceutical industry.
• 3+ year supervisory experience required.
• Bachelor’s degree in related science field.
• CCRP, CCRA, CCRC certifications preferred through the society of clinical research associates or association for clinical research professionals.
• Prior experience with research and clinical trials, as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, safety monitoring, and others.
• Commitment to helping others, while displaying a positive attitude.
• Excellent knowledge of the Google Suite of applications and other data capture systems.
• Strong communications skills with a focus on customer service.

About Blue Signal:

Blue Signal is a leading executive search firm specializing in healthcare recruiting. Our healthcare recruiters have expertise in placing high-performing talent in healthcare IT, medical devices, biotechnology, pharmaceuticals, etc. Learn more at bit.ly/3G5DbWr