LiveCareer-Resume
Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary

Director of regulatory affairs with 15 years of experience in oncology drug development looking to join a team that is passionate about advancing new treatment options for cancer patients.

Skills
  • Managing FDA, EMA Communications
  • Lifecycle Management
  • Regulatory Project Management
  • Grant Writing Experience (NIH, SBIR)
  • Clinical research administration, data collection, and data analysis
  • Software Experience: ETMF, EMR, CTMS
  • Exceptional communication, organization, and time management skills
Experience
Director of Regulatory Affairs, 06/2017 - Current
Cello Health Midland Park, NJ,
  • Oversee regulatory affairs activity for a small biotech company, including preparing IND submissions, liaison with FDA by leading formal meetings and phone/email communications, and life cycle management for several oncology products

Key Accomplishments:

  • Successfully moved a novel biologic from discovery to an ongoing phase 1/2 clinical trial including managing the IND-enabling toxicology study, pre-IND meeting with FDA CBER, and full IND submission which was approved following the initial submission
  • Productive and collaborative EOP2 meetings with FDA CDER for an orphan drug combination drug/device (drug primary MOA) which is now in Phase III clinical trials
Independent Consultant, 08/2015 - 06/2017
American College Of Surgeons Chicago, IL,
  • Prepare pre-clinical grant applications and project management support for early R & D efforts
  • Develop protocols, consent forms and regulatory documents for a new oncology product

Key Accomplishment:

  • Led a successful pre-IND meeting with FDA CBER division
Data Manager, 12/2015 - 06/2017
Children's National Medical Center Fulton, MD,
  • Project management for translational research program
  • Compiled data and progress reports for preclinical research studies
Senior Clinical Research Data Manager, 09/2012 - 12/2015
Moores Cancer Center At UC San Diego Health City, STATE,
  • Built and managed queries, exports, and analysis reports for cancer center investigators and administration
  • Partnered with cross-functional teams on data organization, storage, access and mapping to ensure NCI requirements were met.
  • Created and facilitated in-house training program for database users.
Clinical Trials Regulatory Specialist, 08/2011 - 09/2012
Moores Cancer Center At UC San Diego Health City, STATE,
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Developed standardized templates and training materials for IRB submissions.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Updated in-depth trackers of approvals and submissions.
  • Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
  • Hired team members and trained in collaborative team environment.
Clinical Trials Regulatory Coordinator, 09/2008 - 08/2011
Moores Cancer Center At UC San Diego Health City, STATE,
  • Prepared IRB applications, consent forms, and essential documents for over 50-60 cancer trials
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Demonstrated leadership by making improvements to work processes and helping to train others.
Clinical Research Coordinator Intern, 01/2007 - 06/2008
Moores Cancer Center At UC San Diego Health City, STATE,
  • Coordinated research activities for 160 participants in the (NCI) funded National Lung Screening Trial
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Education and Training
Master of Public Health: Epidemiology, Expected in 01/2008
-
SAN DIEGO STATE UNIVERSITY - San Diego, CA
GPA:
Bachelor of Arts: Biology, Expected in 01/2006
-
POINT LOMA NAZARENE UNIVERSITY - San Diego, CA
GPA:
Received full tuition honors scholarship, 2002-2006
Community Involvement

VISTA GRANDE ELEMENTARY SCHOOL – San Diego, CA 09/19 – Present

Voting Member, Site Governance Team

VISTA GRANDE FOUNDATION – San Diego, CA 09/19 – Present

Voting Member

UPLIFT SAN DIEGO – San Diego, CA 09/09 – 06/12

Volunteer Tutor

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Disclaimer

Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

How this resume scorecould be improved?

Many factors go into creating a strong resume. Here are a few tweaks that could improve the score of this resume:

resume Strength

    Resume Overview

    School Attended

    • SAN DIEGO STATE UNIVERSITY
    • POINT LOMA NAZARENE UNIVERSITY

    Job Titles Held:

    • Director of Regulatory Affairs
    • Independent Consultant
    • Data Manager
    • Senior Clinical Research Data Manager
    • Clinical Trials Regulatory Specialist
    • Clinical Trials Regulatory Coordinator
    • Clinical Research Coordinator Intern

    Degrees

    • Master of Public Health
    • Bachelor of Arts

    By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

    *As seen in:As seen in: