Cover Letter and Resume

Louis Sheehan

9650 Milliken Avenue

APT 4107

Rancho Cucamonga, CA 91730

717.503.8335

Lsheeh14@students.kgi.edu

Dear Sir/Madam,

I am in the process of making a career change.  For more than two decades I worked in accounting, taxation, ERISA/pensions, investments, divorces and medical malpractice. While doing medical malpractice I was exposed to the sciences and was motivated to return to school. I am now prepared to bring my experiences and aptitudes to the pharmaceutical industry, broadly defined. My resume is below.

I was recently engaged on a contract basis to do ‘Quality Consulting’ at more than one compounding pharmacy.

I attended and, in September of 2015, received a certificate from Keck Graduate Institute which emphasizes the life sciences with various sub-specializations.  I now have course work in my major, i.e., Regulatory & Clinical Affairs, as well as in Medical Devices, Validation and Quality and several courses in the Business of Bioscience. My previous employment relating to the Internal Revenue Service exposed me to many sophisticated filings in conjunction with related regulations, interpretations, and applications of policies and guidance.  Further, my work in medical malpractice litigation/settlements had me observing hundreds of surgeries and medical procedures and allowed me to shadow surgeons, physician assistants and nurses for hundreds of hours (which experiences exposed me to HIPAA as well as the underlying sciences, etc.). The classes in the business of bioscience introduced me to the American and International patent regimes.  One project with which I was engaged had to do with a patent application, marketing and licensing of an agricultural-related invention at a local university.  My previous daily work for several large pension funds involved creating partnerships, investing in conjunction with venture capitalists and start-up companies and negotiating financing.

Please see my resume regarding my experience – including my legal experience – and my majoring in Clinical & Regulatory Affairs all in conjunction with my background.

During my decade working at a pension system (a 50 billion dollar fund) I worked within a matrix system with the benefits division, the marketing division, the investments division, the financing division, the executive division and, of course, the legal division. I managed dozens of projects.

I should add that I am a licensed Pharmacy Technician and am licensed by the Pennsylvania, D.C., and Maryland State Bars.

Please refer to LinkedIn for more information which includes links which may be cut and pasted into a browser to see some of my work:

www.linkedin.com/in/louis0j0sheehan

As per the above, at Keck I had classes in Clinical Affairs, Medical Devices and Regulatory Affairs.  By ways of examples, but not by ways of limitation, I wrote Phase-II Clinical Trial SOPs, Protocols, and created a Budget (I have an accounting background and worked for the ‘8’) for a theoretical contraceptive; I analyzed an in vitro glucose monitoring system medical device for purposes of validation in accordance with ISO 15197 Protocols; I reviewed Medtronic’s recently approved 510 (k) for its CRT-D Defibrillator; I led a team submission of a mock IND application to the FDA for Alicaforsen (a drug for ulcerative colitis); I worked with ANDA submissions.  The filings to be performed vis-à-vis my tax background is not overly dissimilar to FDA filings.

As generally referenced above, I have worked with ISO 13485 and 21 CFR 820 (Quality Systems Regulations).  I have experience with inspections, audits (I started out in a Big 8 accounting firm) and academic experience with risk and root cause analysis as well as Design History Files/Device Master records.

My study and experience in validation is broad-based.  My most intensive experience is in analytical validation/product development and ISO 15197:2013(E). However, I also have exposure to other types of Validation.

My compensation expectations are modest and I am willing to travel.  I expect to move/relocate from my current residence in Rancho Cucamonga to any of a number of cities.

I would urge you to contact Dr. Susan Bain, Professor and Program Director, Clinical, Regulatory and Quality Affairs at 909.607.9859 and/or sbain@kgi.edu .

Recognizing that this brief summary cannot provide all of the information needed to describe my skills, experience, and accomplishments, I welcome the opportunity to speak with you in person.

Thank you for your time and consideration.

Sincerely,

Louis Sheehan

Louis Sheehan, J.D., CPhT

9650 Milliken Avenue, Apt 4107

Rancho Cucamonga, California 91730

717.503.8335

Lsheeh14@students.kgi.edu

LINKEDIN: http://www.linkedin.com/in/louis0j0sheehan

SUMMARY STATEMENT

Results-oriented, organized, thorough, over-delivering and resourceful professional who majored in Regulatory and Clinical Affairs and studied Quality/Validation.

EDUCATION

Keck Graduate Institute     Bioscience Certificate                    Claremont, CA                       2014 – 2015

  • Wrote Phase-II Clinical Trial SOPs, Protocols, and Budget for theoretical contraceptive.
  • Led team for submission of mock IND application to FDA for Alicaforsen (drug for ulcerative colitis).
  • Analyzed in vitro glucose monitoring system for purposes of validation in accordance with ISO 15197 Protocols.
  • Reviewed Medtronic’s recently approved 510 (k) for CRT-D Defibrillator assessment for new indications.

Pharmacy Technician Certification 10054681; CA 143371.

Harrisburg University of Science and Technology               Harrisburg, PA                     2009 – 2011

B.S. in Biotechnology & Biosciences

Internship at Dauphin County Coroner’s Office

Magna Cum Laude GPA 3.89

  

University of Maryland School of Law, J.D.                            Baltimore, MD                     1982 – 1985

Taxation

Johns Hopkins University, B.A                                                     Baltimore, MD                       1978 – 1982

Social and Behavioral Sciences

SELECTED KGI COURSEWORK

Introduction to Food and Drug Laws and Regulations, Regulation of Drugs and Biologics, Clinical Trial Design, Conduct and Strategy, Medical Devices, In Vitro Diagnostics, Molecular Basis of DiseasePharmaceutical Development, Bioscience Business.

                                                                  

Fall 2010           Senior Project: Particle Radiation Detection 

  • Hypothesis: Different atomic particles travel in distinct patterns through space and react in   particular ways to magnetic fields.
  • Approach: The construction of a magnetized and ionizable sealed and saturated environment (a cloud chamber) in which the condensed nuclei identify the paths of the varying particles.
  • Results: The paths of Alpha and Beta particles were identified and the interaction of Alpha particles with a magnetic field were quantified.

Spring 2010     Junior Project: Gene Therapy

A recent successful use of Gene Therapy was the treatment of X-linked adrenoleukodystrophy.

  • Paper investigating the preparation and utilization of various delivery systems for Antisense Oligonucleotides in Gene Therapy.
  • Antisense Oligonucleotides are synthetic genetic materials which bind to coding areas of mRNA (the sense strand) thereby neutralizing the targeted translation and thus inhibiting the production of the targeted protein.
  • Numerous viral and non-viral delivery systems were investigated including lipid-based, polymer-based and nanotechnology-based vectors.

RECENT EMPLOYMENT

2015 – Current   Quality Consultant for GXP Consultants, Inc.

 My duties include work relating to but are not limited to:

  • Batch Records/Correlation Matrices,
  • Stability Data/Program,
  • Vendor and Internal Audits,
  • Noncompliance Reports,
  • Patient Complaints,
  • Validation and
  • 503 Compliance.

2000 – 2014 Attorney

  • Negotiated divorce/QDRO issues relating to pension allocations.
  • Investigated facts, monitored trials and negotiated settlements relating to medical malpractice.

1991 – 2000 Assistant Counsel, Public School Employees’ Retirement System (PSERS)

  • Represented PSERS in administrative hearings and court appearances. My first case was (successfully) concluded by Pennsylvania’s Supreme Court.
  • Advised PSERS’ staff on issues and submitted numerous filings involving Trusts, Guardianships, Wills, Severance Arrangements, POAs, taxes, accounting and debt collections, investment contracts, the IRS and the Pennsylvania Department of Revenue.

AWARDS & VOLUNTEER WORK

Johns Hopkins Scholar.

National Merit Scholar.

WITF Public Broadcasting – Led Call Center for Smart Talk Television Program.

Scores, Schools and Grades

GRE: 710, 640 {1350} [I believe out of 800/800] and 5.5 out of 6.0 on writing.  These scores are estimated/recalibrated in the new rankings to be 167, 151 {318} and 5.5 out of 6.0 on the writing.

LSAT: 719 (97th percentile).

SAT (taken in 1978): 1360 which was in the 99th percentile/Verbal of High School Students and 98th percentile/Math of High School Students.

Keck Graduate Institute GPA: 3.27 out of 4.0.

Midland College GPA:  4.00 out of 4.00.

Biology 8 Units

Harrisburg University of Science and Technology GPA:  3.89 out of 4.00.

Biotechnology, etc. 75 Units

Lebanon Valley College GPA:  3.31 out of 4.00.

Chemistry 8 Units

Harrisburg Area Community College GPA:  3.91 out of 4.00.

Biology, etc. 84 Units

Texas Tech University GPA:  3.84 out of 4.00.

Accounting/Taxation 33 Units

The Law School Grades at the University of Maryland were based on a system established in the 1816-1824 era and would be misleading.

Hopkins GPA:  3.07 out of 4.00.

Humanities 121 Units

I attended Harvard University by taking some classes there while in high school; I can no longer recall my GPA there.

Writing/Work Examples

Please see a more complete and accessible collection of information and examples than is permitted by LinkedIn’s space limitations at the following links:

Mock FDA Submission of Pharmaceutical Label

[Copy and paste link into your browser.]

[Click on the individual pages to increase their sizes.]

https://masterkan.wordpress.com/2015/08/11/mock-alicaforsen-lebel-by-louis-sheehan-entirely-fabricated/

Ancestry Tracing With Genetics

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[Copy and paste link into your browser.]

https://masterkan.wordpress.com/2015/08/01/ancestry-tracing-with-genetics-louis-sheehan/

Pharmacy Technician

https://masterkan.wordpress.com/2015/07/31/louis-sheehan-pharmacy-technician-certification-board-cert-num-10054681-july-7-2014-july-31-2016/

Tax Brochure I Wrote for Pennsylvania’s Retired School Employees

[Copy and paste link into your browser.]

[Click on the individual pages to increase their sizes.]

Below is a link to an example (real world) brochure I wrote last century which has been updated only to add internet/website information.  I ask for your indulgence when evaluating its clarity in that it is keyed to a population knowledgeable about the subject and involves federal income taxation of pension benefits for Pennsylvania’s school employees.  That pension system has existed since the early 20th century and, overtime, many idiosyncratic state and federal laws were passed relating to the benefits provided and the tax treatment thereof.  Which is to say, it may still read ‘like Greek’ to you given no real-world context, but I hope you and yours can see through that surface-level limitation.

http://www.psers.state.pa.us/content/publications/pampletseries/Taxes.pdf

Writing Sample: Clinical Trial Gone Wrong

 

https://masterkan.wordpress.com/2015/09/26/writing-sample-clinical-trial-gone-wrong/

Writing Sample: J&J Memo/Credo

 

https://masterkan.wordpress.com/2015/09/26/writing-sample-jj-memo-credo/

 

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Louis Sheehan
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