Regulatory Affairs Specialist II

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional ethical physical and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth dignity and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET Managing Up Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees experiential journeys to ensure strong communication ease of access to information and a seamless experience

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Actively supports the organizations vision fulfills the mission and abides by the I CARE values

• Collaborates with cross-functional teams including key study personnel. Role models strong positive communication skills to ensure cohesive smooth operation of the department.

• Interfaces as needed with health authorities regarding product development filing or registration activities.

• Maintains a professional and credible image with FDA and other regulatory agencies.

• Initiates contributions towards improvement of department scores for employee engagement i.e. peer-to-peer accountability.

• Prepares correspondence progress compliance reports and other documentation relative to regulatory aspects of projects. Maintains regulatory approvals from applicable health authorities.

• Supports sponsor responsibilities for clinical trials being conducted under an Investigational New Drug (IND)/Investigational Device Exemption (IDE).

• Reviews and approves regulatory information contained in protocols clinical study reports and compliance reports.

• Assists with execution of developed regulatory plans and interfaces with project team members both within the organization and with a diverse range of external groups to drive initiatives to completion.

• Provides substantial contribution to ensuring Houston Methodist is compliant with all local county state and Federal agency regulatory requirements for investigational medical device and drug applications.

• Provides routine updates and reporting to the Director/Administrator to ensure timely communication regarding status of regulatory compliance matters.

• Conducts critical review of regulatory submissions to ensure accuracy adequacy consistency and conformance to regulatory requirements.

• Works effectively with vendors and consultants to ensure services received are accurate and in accordance with executed agreements.

• Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks assisting coworkers as needed.

• Coordinates and submits timely responses to regulatory agency inquiries.

• Keeps abreast of regulatory requirements which includes monitoring FDA and other agencies regulations and standards.

• Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.

• Bachelors degree in life sciences or related field

• Masters degree preferred

• Four years of Regulatory Affairs experience within an FDA regulated industry preferably devices diagnostics or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities

• Experience of successful submission of applications to Health Authority including Investigational Drug Device (IND/IDE) compassionate use pre-submission requests market applications

• N/A

• CCRC - Certified Clinical Research Coordinator (ACRP) OR
• CCRA - Certified Clinical Research Associate (ACRP) OR
• ACRP-CP - Clinical Research Professional (ACRP) OR
• RAC - Regulatory Affairs Certifications (RAPS)

• Demonstrates the skills and competencies necessary to safely perform the assigned job determined through on-going skills competency assessments and performance evaluations

• Sufficient proficiency in speaking reading and writing the English language necessary to perform the essential functions of this job especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate with patients physicians family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

• Demonstrated knowledge and applied expertise in IND/IDE processes

• Skilled at managing multiple projects with conflicting priorities

• Excellent communication and interpersonal skills

• Proficient in MS Office products (Word Excel PowerPoint Outlook Project)

• Working knowledge of US regulations and guidance including but not limited to FDA 21 Code of Federal Regulations

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No
• Scrubs No
• Business professional Yes
• Other (department approved) No

ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster Severe Weather Events etc) regardless of selection below.

• On Call* No

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area Yes
• May require travel outside Houston Metropolitan area Yes

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540000 square foot building dedicated to research the research institute houses over 1500 staff and trainees 284 principal investigators and has more than 570 ongoing clinical trials.