Honor Health

Nonprofit healthcare system providing comprehensive care

Manager – Regulatory Affairs

Regulatory & Quality (Life Sciences)Posted on Nov 9

Full-timeScottsdale, AZ, USANo salary listed

About the Job

Requirements

A bachelor's degree or at least five years of clinical research experience is required.
At least four years of clinical research experience is required, including data coordination, document and regulatory management, regulatory compliance, and regulatory assurance.

Responsibilities

Manage a team that executes regulatory strategy and oversee regulatory matters.
Develop and execute goals and strategy to ensure compliance with applicable regulations and efficient regulatory management across research service lines.
Develop regulatory processes and systems to ensure required licensing, filings, and certifications are processed and monitored.
Establish regulatory policies and procedures and partner with compliance to establish monitoring procedures.
Ensure compliance with existing regulations and lead implementation of regulatory requirements.
Investigate legal changes and reported non-compliance issues, and implement related policy or workflow changes.
Provide regulatory expertise, ongoing support, education, and training to regulatory and clinical research staff on the regulatory conduct of clinical research studies.
Develop and implement operating procedures for the regulatory department.
Serve as the regulatory expert to internal departments and external agencies, ensuring regulatory compliance for all research studies at HRI.
Facilitate communication between Regulatory Affairs and other departmental leadership to align training and staff development with key timelines and milestones.
Develop and monitor the regulatory department budget.
Manage day-to-day Regulatory Affairs staff operations and assign workloads to Regulatory Affairs coordinators.
Ensure work is completed in a timely manner in accordance with institutional policies and procedures, regulations, and guidance documents.
Develop and implement departmental processes incorporating Lean Methodology where appropriate and good clinical practice for clinical trials.
Recruit and retain regulatory staff through role modeling, fostering peer relationships, staff education, and participation in preceptor or mentor programs.
Foster collaborative relationships with departments across HonorHealth Research Institute.
Interview, select, and recommend hiring personnel.
Administer performance evaluations in collaboration with the Director; independently administer staff discipline through the second stage and participate with management in subsequent stages.
Edit and approve time in Laborworkx.
Evaluate use and availability of equipment, supplies, and space, and maintain appropriate inventory levels.
Identify needs and develop new policies and workflows.
Collaborate with Directors, Research Quality, Regulatory & Compliance, and research clinics to establish and implement process improvements.
Develop and monitor budgets, identify fiscally responsible efficiencies, and implement them.
Serve as a resource to staff, providers, sponsors, vendors, and visitors.
Facilitate interdepartmental and intradepartmental collaboration and communication, and promote problem solving.
Perform other duties as assigned.

Desired Qualifications

A master's degree in a healthcare area or at least five years of clinical research experience.
Six years of Regulatory Affairs experience.
American Association of Cardiovascular and Pulmonary Rehabilitation Certified Cardiac Rehabilitation Professional certification, or certification as a Clinical Research Professional by SoCRA.
Certified Clinical Research Coordinator certification.

Primary City/State:

Shea Medical Office Building - 10290 N 92nd St Scottsdale, AZ 85258

Category:

Risk, Government and Regulatory Affairs

Shift:

Day

Department:

HRI-Regulatory Affairs



Hybrid, must reside in Arizona

Monday - Friday, 8:00am-5:00pm

Great care starts with great people. (Like you.)

At HonorHealth, you’ll find something special. From humble beginnings in 1927 to one of Arizona’s largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most — caring for the health and well-being of people and communities across the greater Phoenix area.

Responsibilities:

JOB SUMMARY

Manages a team that executes the strategy of regulatory. Oversees all regulatory matters. Develops and executes the goals and strategy to ensure the organization complies with applicable regulations and the efficient management of regulatory of all research service-lines. Develops regulatory processes and systems to ensure that all necessary licensing, filings and certifications are processed and monitored. Establishes regulatory policies and procedures and partners with compliance to establish same for monitoring. Ensures compliance with existing regulations and leads the respective implementations. Investigates and addresses any legal changes, reported issues of non-compliance, and is responsible for the related policy and or workflow change. Provides in-depth knowledge, expertise, ongoing support, education and training to regulatory and clinical research staff regarding the regulatory conduct of clinical research studies. This position is responsible for the development and implementation of department operating procedures for the regulatory department. Serves as regulatory expert to interdepartmental and external agencies, ensuring regulatory compliance for all research studies at HRI. Facilitates communication between the Regulatory Affairs department and other departmental leadership to align training and staff development to meet key timelines and milestones. Develops and monitors budget for regulatory department.

ESSENTIAL FUNCTIONS

Manages day-to-day operations for the Regulatory Affairs staff. Assigns workloads to the Regulatory Affairs coordinators. Ensures work is completed in a timely manner following institutional policies/procedures, regulations and guidance documents. Develops and implements departmental processes incorporating the Lean Methodology where appropriate and good clinical practice for the conduct of clinical trials.
Recruits and retains talented regulatory staff through positive role-modeling, fostering peer relationships, staff education, and participating in preceptor and/ or mentor programs thereby creating an environment for quality practice. Fosters collaborative partnerships/relationships with all departments within HonorHealth Research Institute. Interviews, selects, and recommends hiring of personnel. Administers performance evaluation in collaboration with the Director. Independently administers staff discipline through the second stage (written); participates with management in following stages. Edits and approves time via Laborworkx. Evaluates utilization and availability of equipment, supplies, and space. Monitors and maintains appropriate inventory levels.
Identifies need and develops respective new policy and workflows. Responsible to collaborate with Directors, Research Quality, Regulatory & Compliance, and research clinic to establish and implement process improvement.
Develops and monitors budgets, identifies fiscally responsible efficiencies, and implements same. Serves as a resource to other, including staff, providers, sponsors, vendors and visitors. Facilitates inter/intra departmental collaboration, communication and promotes problem solving.
Performs other duties as assigned.

EDUCATION

Bachelors or at least 5 years clinical research experience Required
Masters in healthcare area or at least 5 years clinical research experience Preferred

EXPERIENCE

4 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance and regulatory assurance Required
6 years Regulatory Affairs experience Preferred

LICENSE AND CERTIFICATIONS

American Association of Cardiovascular and Pulmonary Rehab–Certified Cardiac Rehabilitation Professional - Certification Clinical Research Profession by SoCRA Preferred
Certified Clinical Research Coordinator - Certification Clinical Research Coordinator Preferred

We're all in for your career.

About the Company

Honor Health

Nonprofit healthcare system providing comprehensive care

Preparing company summary for Honor Health.

Company size: 5,001-10,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Scottsdale, AZ
Founded: 2013

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