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Regulatory Affairs Specialist Jobs
Recruited by ICON 8 months ago Address , Farmingdale, 11735

Senior Regulatory Specialist Jobs

Company

Stanford University
Address , Stanford, Ca
Employment type FULL_TIME
Salary $77,000 - $134,000 a year
Expires 2023-07-19
Posted at 11 months ago
Job Description

Senior Regulatory Specialist – Center for Cancer Cell Therapy

**This Senior Regulatory Specialist Position will be home based from anywhere within the United States**


The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Senior Regulatory Specialist to be responsible for the administration and regulatory compliance of clinical research within the university, and representing the university with external regulatory agencies, both domestic and international. This position will support high-impact early phase clinical trials in the CCT group in a variety of cancer indications in both adult and pediatric patient populations.


The Senior Regulatory Specialist will work within in multidisciplinary teams of highly-skilled physicians, research scientists, cell manufacturing experts, and clinical research staff to conduct innovative early phase clinical trials according to Good Clinical Practice and all relevant institutional, state, and federal policies. We are seeking candidates with excellent communication skills, teamwork, and superb attention to detail. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility.


We are looking for someone who already has a strong foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies. RAC certification not required, but some previous coursework or prior jobs in regulatory affairs is expected.


Duties include:

  • May direct and/or supervise staff.
  • Assess training needs and may develop associated training.
  • Lead the planning and operations for programs or functions that have significant business, regulatory and/or technical challenges requiring subject matter expertise.
  • Evaluate programs or functions, policies and procedures. Identify issues, and develop alternative solutions which may include changes to programs, policies and procedures.
  • May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.
  • Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
  • Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
  • Represent the program or function within the department, unit or school. Commit resources and provide information and/or training. Represent the program or function at the university level and/or to external/internal stakeholders and constituencies.
  • - Other duties may also be assigned

DESIRED QUALIFICATIONS:

Desired qualifications include a basic understanding of human subjects research regulations, or extensive experience with CAR-T cells or cellular therapy in general. Previous experience writing protocols or other scientific writing is desirable.


EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.


KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Demonstrated ability to develop and meet budget goals.
  • Excellent interpersonal, written and oral communication skills.
  • Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
  • Demonstrated solid planning and organizational skills.
  • Ability to direct the work of others, for jobs requiring supervision.
  • Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
  • Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
  • Demonstrated experience working independently and as part of a team.
  • Strong relevant subject matter knowledge.


PHYSICAL REQUIREMENTS*:

  • Frequently stand/walk, sitting, grasp lightly/fine manipulation.
  • Occasionally use a telephone.
  • Constantly perform desk-based computer tasks.
  • Rarely lift/carry/push/pull objects that weigh 11-20 pounds.
  • *Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORK STANDARDS:

  • Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
  • Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
  • Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

This remote role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate. The expected pay range for this position is, $77,000 to $134,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.