At Boston Children's Hospital, success is measured in patients treated, parents comforted and teams taught. It's in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Research Programs and discover how your talents can change lives. Yours included.
The Senior Compliance and Regulatory Affairs Manager will be responsible for:
Independently leading the facilitation of clinical trials with the FDA on all investigator initiated FDA regulated clinical trials involving Drugs, Devices and Biologics.
Serving as an institution wide regulatory compliance and regulatory affairs expert to develop, implement and ensure compliance with policies, procedures and training to ensure internal/external regulatory compliance in relation to the Food and Drug Administration.
Collaborating with investigators and their research teams, and other involved institutional groups in IND/IDE development and management.
Establishing Good Clinical Practices and Sponsor/Investigator responsibilities as well as developing and implementing strategies to improve and ensure that Boston Children's Hospital supports and conducts FDA regulated research in accordance with all required regulations.
Directing, developing and supervising the monitoring requirements for Clincaltrials.gov.
Contributing to the ongoing evaluations and needs or resources required to support FDA regulated research and will serve as an educator for investigators and administrators.
To qualify, you must have:
Bachelor's degree plus a minimum of 5-7 years of experience in a drug or device regulatory environment.
Master's Degree preferred.
Knowledge of regulatory requirements and guidelines for pre-clinical research, with specific knowledge of development or monitoring requirements.
Knowledge of FDA regulations and Good Clinical Practices.
Certification as a CCRP (SoCRA), CCRC or CCRA (ACRP), or RAC (Regulatory Affairs).
Specific expertise in the areas of cell and gene therapy and FDA regulatory affairs for drugs, devices and biologics, desirable.
This position is eligible for an Employee Referral Bonus.
Boston Children's Hospital offers competitive compensation and unmatched benefits, including affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts and discounted rates on T-passes (50% off). Discover your best.
Boston Children's Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.
Department: Research-Clinical Research Core Programs
Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care. As one of the largest pediatric medical centers in the United States, Children's offers a complete range of health care services for children from birth through 21 years of age.