Supervisor, Regulatory Affairs - Pediatrics - Allergy & Immunology (90002422)

Baylor College of Medicine

Houston, TX

Job posting number: #7087570 (Ref:9117-en_US)

Posted: October 21, 2021

Application Deadline: Open Until Filled

Job Description

Summary

Baylor College of Medicine, Department of Pediatrics, Immunology, Allergy and Retrovirology Service at Texas Children’s Hospital is seeking a highly motivated, responsible, and organized Regulatory Affairs Supervisor. Will be responsible for supporting research studies in the Food Allergy Research Program, research in the fields of immunological disorders and HIV. 

Job Duties

  • Ensures meticulous regulatory reporting, patient tracking and follow-ups with the Principal Investigators.
  • Responsible for development of the research studies, development planning and implementation, providing regulatory advice, preparing FDA submissions, maintaining regulatory files, and critical thinking.  
  • Supervises the day to day operations of Research Regulatory Affairs team, including delegating work assignments and deadlines pertaining to clinical trial forms, records retention, and government filings.
  • Maintains current knowledge of FDA regulation, guidance and standards.
  • Leads regulatory team personnel in ensuring processes compliance with Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and FDA requirements.
  • Coaches on team effectiveness and relationship building.
  • Takes on the Senior Team Lead role without direction, and helps to develop together through team activities.
  • Responsible for interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline.
  • Develops and implements processes for ensuring productivity/accountability.
  • Identifies and implements process improvement opportunities.
  • Develops an excellent understanding of key regulations and implications of current work within role.
  • Takes the lead on key functional projects and develops Subject Matter Expertise within the team.
  • Generates, reviews and reports department metrics on a monthly basis (NIH grants, clinical trials, IRB submissions).
  • Establishes corrective measures to address issues.
  • Researches and responds to complex and unusual inquiries in a timely and professional manner.
  • Demonstrates clear and concise communication with key stakeholders within the organization.
  • Seeks to lead collaboration efforts and thinks broadly about communicating to key stakeholders.
  • Implements short term goals that align with the company’s vision and business goals.
  • Cascades goals down to staff’s annual objectives.

Minimum Qualifications

  • Bachelor’s degree in a Basic Science, Healthcare, or a related field.
  • Four years of relevant experience.

Preferred Qualifications

  • Master's degree in a related field.

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 9117

 



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.


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More Info

Job posting number:#7087570 (Ref:9117-en_US)
Application Deadline:Open Until Filled
Employer Location:Baylor College of Medicine
Houston,Texas
United States
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