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Job Description

The Division of Research is one of the nation's largest research facilities outside of a government or university setting. We are the primary professional home of more than 60 research scientists and 600 staff members who lead studies in epidemiology, health services, and clinical trials. Our studies cover a wide range of clinical topics, including cardiovascular disease, cancer, diabetes, substance abuse, mental health, maternal and child health, and women's health. Our research addresses broad issues, including the role of genes and the environment in health, the influence of behavior on disease prevention and chronic illness management, drug safety, health care policy, health services delivery, and disparities. We have almost 400 ongoing projects and contribute more than 500 scientific papers to peer-reviewed journals each year.

• Oversee all aspects of Regulatory staffing, operations, systems, and expansion.

• Set vision and strategy for expanding regulatory teams that include both staff recruitment and retention strategies, and portfolio expansion strategies.

• Establish and operationalize policies, Standard Operating Procedures (SOPs), and quality assurance processes that ensure program compliance; partner with CRS Compliance and Regulatory Affairs Program to align with existing policies and systems.

• Partner with Clinical Research Management (CRM) to establish and maintain well-defined work flows, roles and responsibilities, and communications to ensure effective integration between regulatory and clinical operations.

• Oversee management and system support for an enterprise-wide eRegulatory and eSubject management system, Florence, including on-boarding, training, SOP management, user group engagement, trial migration, and quality control.

• Create roadmap and oversee implementation of new Florence modules, functionality, and integrations with other Consortium systems.

• Identify Regulatory improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.

• Lead change management across study teams in support of increased regulatory management; establish faculty relationships and channels of communications to keep faculty apprised of central regulatory operations.

• Form strong partnerships with disease group teams and Clinical Trials Program leaders, developing standard report-outs for each centrally managed portfolio.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

Bachelor's degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters' degree may substitute for two years of experience

Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines

Minimum five years in a quality management role with direct reports

In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems

Demonstrated experience identifying areas for improvement and implementing solutions; ensuring compliance with standards, regulations and company procedures; and

administering successful programs within appropriate timelines

Experience conducting training for quality assurance and/or regulatory affairs

Ability to interact positively with all levels of staff and external contacts

Proficiency in Microsoft Word, Outlook, Excel and PowerPoint

Excellent verbal and written communication skills

Experience adopting a flexible, proactive, and service-oriented approach

Travel may be required Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred

Experience with on-site monitoring

Spanish language skills a plus null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.