Anna Hertzberg Email & Phone Number

Boston, Massachusetts, Us

Boston, Massachusetts, Us

I contribute to cross functional teams in successful health authority meetings and initial and subsequent IND submissions, navigating difficult outcomes in the areas of oncology, neurology, gene therapy and vaccines. I provide regulatory support for product development programs ranging from early-to late-stage development.

Cambridge, Ma, Us

Lead Global Regulatory Team on a complex oncology program including maintaining 6 indications and approvals in over 75 countries.Attend as well as assist in planning and implementing FDA interactions to progress regulatory strategy for cancer therapy into pediatrics and earlier lines of therapy.Represent regulatory affairs on teams conducting Phase 3 trial, applications for supplements and other labeling updates and responses to queries.Plan and facilitate various submissions to FDA (IND and NDA), Health Canada and other health authorities including authoring and reviewing various documents.

Cambridge, Ma, Us

Represent regulatory affairs on teams to plan Phase 3 trials, applications for new indications and other labeling updates and responses to queries.Assist in submissions for marketing applications and subsequent activities for the company's newest cancer therapy, which was approved by FDA in November 2015 and EMA in November 2016. Plan and facilitate submissions to FDA (IND and NDA), Health Canada and other health authorities including authoring and reviewing various documents. As an intern Summer of 2015 constructed a database of current and past clinical trials for various oncology indications.

Train new employeesSort and price clothes from customersCommunicate the needs of the store to co workers and the ownerHelp create outfits for display and customers

Montreal, Quebec, Ca

Ran science shows at birthday parties and other events.Teach an hour long class 5x a week to elementary school kids.

Wellesley, Ma, Us

Take notes and implement changes according to weekly meetings of lab.Taught and performed mouse handling techniques, injections, perfusions and sectioning of tissue. Maintained laboratory inventory, ordered reagents and shipped out DNA as well as general management of lab.

Cambridge, Ma, Us

Helped improve Morris water maze set up: revised protocol, recorded results and analyzed findings.Developed expertise in various sites of intracranial injections using stereo tax, perfusion, brain extraction and sectioning with vibratome and cryostat.

Completed weekly test of fecal coliform using filters and incubationTested and calibrated pH and DO probesMaintained grey water systemLed tours of machine, building, and facilities

During two summers I supervised up to six counselors and 26 campers Gave feedback and written weekly evaluations to staffPlanned and coordinated unit activities and cabin schedules

Developed recycling and conservation programsCompiled a curriculum on various methods of compostingSupported fellow staff in daily activities

Led campers in activities including: ropes course, duck pond, swimming, and gamesCounseled children from seven through 15

Portland, Oregon, Us

Conducted independent research testing how deletion of the Srd5a1 gene affects alcohol-related behaviors of miceCompleted five behavioral tests on an sample of 80 micePrepared and presented PowerPoint and poster on research results

Portland, Oregon, Us

Sectioned and mounted mice brains on slidesConducted gel electrophoresis and DNA isolationWeaned, weighed and maintained colony of mice

Master'S Degree, Regulatory And Clinical Research Management

Certificate, Clinical Research

Ba, Neuroscience