HIM Director

Description:

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.

Required Qualifications:

? 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

Desired Knowledge, Skills and Abilities:

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

? Experience with on-site monitoring

? Expert planning and organization skills

? Strong attention to detail

? Exceptionally team focused; actively contributes to a positive and innovative work environment

? Able to demonstrate the highest ethical standards; promotes trust, respect and integrity

? Spanish language skills a plus

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

---