Regulatory Affairs Specialist II

Job ID 2020-36377
Area of Interest
Research & Development
Location Name
Metropolitan Park West
FTE/Hours per pay period
1.0 FTE (80 hours per bi-weekly pay periods)
Work Status
Regular
Department
Immunotherapy Integration Hub
Shift
Day Shift
Primary Location : City
Seattle
Primary Location : State/Province
WA

About Us

Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible.  Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE

 

As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

 

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. 

 

Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Report’s top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.

 

We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

Overview

Responsible for the coordination and oversight of safety reporting activities for trials managed by the Immunotherapy Coordinating Center (ICC). Responsible for assisting in the coordination, preparation, submission, and archival of assigned regulatory submission packages and reports for trials sponsored and managed by the Immunotherapy Coordinating Center (ICC). Contribute to the development and maintainence of all ICC Regulatory Affairs shared sites and applications for automating, tracking, and archiving all ICC regulatory submissions. Provide input on Regulatory Affairs workflows to increase efficiencies and automation for ICC regulatory submission processes. Support Regulatory Affairs department by acting as a back-up to the Regulatory Affairs Supervisor and Manager for all regulatory activities. Contribute to the development of the ICC Quality Management System and Regulatory Affairs department inititives, including but not limited to, developing and reviewing department guidelines, work instructions, standard operating procedures, and performing quality control reviews.

 

Seattle Children’s Employer Highlights:
• Leader in Pediatric Care: Because of our people, Seattle Children’s is recognized as a leading teaching, research and specialty care center at the forefront of pediatric care.
• Competitive Benefits: We support a healthy work–life balance. Our benefits include employee care, paid time off, health insurance and retirement savings.
• Diversity/Inclusion: We strive to maintain an atmosphere that reflects our values of inclusion by providing effective and respectful care compatible with each patient and family's beliefs, values, and heritage.

 

#LI-MF1

Requirements

Required Education/Experience:

- Bachelor’s degree in biological sciences or health related field.
- Minimum of two (2) years' experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting.

 

Preferred:
- Master’s degree in biological sciences or health-related field.
- At least five (5) years' experience in a regulatory role.
- Experience in drug and device approval process.
- RAPS certification or equivalent.

Our Commitment to Diversity

Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

 

The people who work at Seattle Children’s are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

 

Seattle Children’s is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

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