Resume and Cover Letter

Louis Sheehan,

9650 Milliken Avenue

APT 4107

Rancho Cucamonga, CA 91730


Dear Sir/Madam,

I am in the process of making a career change. As referenced generally in my resume, I attended Keck Graduate Institute which emphasizes the life sciences with various sub-specializations. I have significant science, legal, medical, and accounting backgrounds as well as course work in Regulatory & Clinical Affairs, Validation, Medical Devices and several courses in the Business of Bioscience. My work relating to the Internal Revenue Service exposed me to many sophisticated filings in conjunction with related regulations, interpretations, and applications of polices and guidance. Further, my work in medical malpractice litigation had me observing hundreds of surgeries and medical procedures and allowed me to shadow surgeons, physician assistants and nurses for hundreds of hours. The classes in the business of bioscience exposed 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 invention at a local university. My daily work for several large pension funds involved creating partnerships, investing in conjunction with venture capitalists and start-up companies and negotiating financing.

At Keck I had classes in Medical Devices as well as Regulatory and Clinical Affairs. By ways of examples, but not by way of limitation, I wrote Phase-II Clinical Trial SOPs, Protocols, and created a Budget (I have an accounting background and worked for the ‘Big 8’) for a theoretical contraceptive; I lead a team submission of a mock IND application to the FDA for Alicaforsen (a drug for ulcerative colitis); 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. The filing performed vis-à-vis my tax background is not overly dissimilar to FDA filings.

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 am a licensed Pharmacy Technician.

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

As 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.

I have majored in Regulatory & Clinical Affairs and studied Validation. 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. I have worked with ISO 13485 and 21 CFR 820 (Quality System Regulations). Please see my resume regarding my experience – including my legal experience – and study of Clinical & Regulatory Affairs in conjunction with my background.

Please note that 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 .

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.


Louis Sheehan


Louis Sheehan, J.D., CPhT

9650 Milliken Avenue, Apt 4107

Rancho Cucamonga, California 91730




 Results-oriented, organized, thorough, and resourceful professional studying Validation and majoring in Regulatory and Clinical Affairs.


 Keck Graduate Institute                                                          Claremont, CA       2014 – 2015

  • Wrote Phase-II Clinical Trial SOPs, Protocols, and Budget for theoretical contraceptive.
  • Lead 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 3.8


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


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

       Social and Behavioral Sciences


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.


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.


 Johns Hopkins Scholar.

National Merit Scholar.

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

Scores and GPAs

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.

Midland College GPA: 4.0 out of 4.0.

Harrisburg University of Science and Technology GPA: 3.86 out of 4.0.

Lebanon Valley College (Chemistry classes only): 3.31 out of 4.0.

Harrisburg Area Community College GPA: 3.91 out of 4.0.

Texas Tech University GPA: 3.84 out of 4.0.

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

Hopkins GPA: 3.07 out of 4.0.

I attended Harvard University during high school by taking a few classes, but I can no longer recall my GPA there.

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.]

Ancestry Tracing With Genetics

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[Copy and paste link into your browser.]

Pharmacy Technician

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.

LinkedIn Supplement

[Copy and paste link into your browser.]


About masterkan

Louis Sheehan
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