Cell & Gene Therapy Benefits Specialist

About the role

Join a dynamic team dedicated to advancing cell and gene therapy. This role is responsible for ensuring the highest standards of patient care and regulatory compliance.

Responsibilities

• Collaborate with clinical teams to ensure accurate documentation and compliance with regulations.
• Manage regulatory submissions and maintain records in accordance with FDA guidelines.
• Support the development and implementation of quality assurance programs.
• Provide training and guidance to other team members on regulatory requirements and best practices.

Requirements

• Bachelor’s degree in a relevant field such as biology, biochemistry, or healthcare.
• Minimum 3 years of experience in a regulatory or quality assurance role within the pharmaceutical or biotech industry.
• Knowledge of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.

Qualifications

• Current certification in a relevant field such as Certified Regulatory Affairs Professional (CRP) or Certified Clinical Research Professional (CCRP).
• Experience with electronic data capture systems and regulatory databases.
• Ability to work independently and manage multiple tasks simultaneously.

Skills

• Proficiency in Microsoft Office Suite.
• Experience with regulatory filing processes.
• Understanding of GMP and GLP guidelines.

Benefits

• Competitive salary package.
• Flexible working hours.
• Professional development opportunities.
• Health insurance coverage.
• Employee wellness programs.

Pay

• $XX.XX per hour.

Schedule

• Full-time position.

Contact

To apply, please fill out the form below. We look forward to hearing from you!