Regulatory Affairs Specialist II - AOCT

At Houston Methodist, the Regulatory Affairs Specialist II position is responsible for coordinating regulatory submission filings of both investigational and marketed products utilized at Houston Methodist for patient care and research activities. This position is responsible for end-to-end compiling of information needed to support investigational applications to Food and Drug Administration (FDA) and other relevant health authorities. Along with initial filings of applications, the Regulatory Affairs Specialist II position will also maintain compliance reporting and regulatory approvals from applicable health authorities. This position will interface with the FDA and other applicable health authorities.

Requirements:

Qualifications:

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

LICENSES AND CERTIFICATIONS - PREFERRED

• 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)

KNOWLEDGE, SKILLS, AND ABILITIES

• 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

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an Equal Opportunity Employer.