Assistant Quality Control
Resume:
Rachel Axman
******.*****@*****.***
**** ********* ****** *** *****, Philadelphia, PA 19146
EDUCATION:
Neuroscience: Cellular and Molecular, Bachelor of Science
Cum Laude, Distinction in Major, Dean’s List 2011-2015
Temple University, College of Science and Technology
Math and Science GPA: 3.76 Overall GPA: 3.69
University Honors Program
Charles Hodge IV Prize in Biology Recipient
Honors Program Peer Mentor
NCAA Student Athlete Academic Tutor and Mentor
PROFESSIONAL EXPERIENCE:
Regulatory Associate May. 2015-Present
Pfizer Inc., Collegeville, PA– Worldwide Safety and Regulatory, Global Established Pharma Regulatory Affairs
Support preparation of Health Authority submissions and ensure timely submission and completeness of the submission package by tracking, analyzing and solving submission problems for assigned GEP projects/products.
Participate on project teams for GEP products, including Methylphenidate Extended Release Chewable Tablet and Quillivant Oral Suspension, and actively coordinate and follow up with relevant team members.
Prepare team meeting notes as needed for Labeling, Regulatory Strategy and Rapid Response Teams (RRT).
Log Health Authority communications and issue Records of Contact (ROC) on behalf of Regulatory Strategists.
Conduct Quality Control reviews for documentation developed by Regulatory Strategists
Regulatory Strategy Intern Jun. 2014-Aug. 2014
Pfizer Inc., New York, NY– Worldwide Safety and Regulatory, Global Established Pharma Regulatory Affairs
Developed and launched a survey of all regulatory personnel regarding requests for the FDA’s Critical Path Initiative on pediatric development for submission to the BIO industry group.
Coordinated the output of the Drug Development functions into an application to market the product, which fulfills the regulatory requirements for the country specific applications.
Researched and located guidance and regulations in internal and external systems to contribute to building an internal regulatory intelligence and knowledge resource and reference guide.
Laboratory Research Assistant May 2013- Jan. 2015
Temple University School of Medicine, Philadelphia, PA- Center for Neurovirology and Comprehensive NeuroAIDS
Conducted research aimed at elucidating the structure and function of Agnoprotein, a small regulator of the JC virus, in order to develop treatment for Progressive Multifocal Leukoencephalopathy (PML).
Presented Poster entitled “The JC Virus Agnoprotein and Mitochondrial Function” at the Temple Undergraduate Research Forum.
Attended weekly departmental seminars to gain knowledge of research projects around the world.
RELATED EXPERIENCE/ACTIVITIES:
Vice-President and Founder, Sustainable Growth Initiative Nov. 2013- May 2015
Clinical Observer Dec. 2013- May 2014
oDr. Bong-Soo Kim: Director of Neurosurgical Spine Surgery, Temple University Hospital
oDr. Thomas Fekete: Chief of Infectious Disease, Temple University Hospital
oDr. Harry Akoto: Neurosurgeon, Korle-Bu Teaching Hospital Accra, Ghana
oDr. Lawrence Sereboe: Chief of Cardiothoracic Surgery, Korle-Bu Teaching Hospital, Accra, Ghana
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