Medical Process Improvement
Resume:
Edison, NJ www.linkedin.com/in/mukulnpatel
***********@*****.***
medical writing/ReGULatory
Microbiologist/Biochemist with broad expertise in independent medical and
scientific writing and publication including planning, production and
submission of documents in support of drug development and exploratory
research
. Investigated, prepared and published clinical study reports, manuscripts,
abstracts, oral presentations, grant proposals, SOPs, feasibility
protocols, validation protocols, validation reports, annual reports,
investigator brochures etc. Reviewed, analyzed and interpreted lab data,
batch records, medical charts etc
. Identified key opinion leaders, initiated and managed collaborative
research and product development projects.
. Interest and experience writing in various therapeutic areas, such as,
HIV, HCV, infectious diseases, oncology, immunology, dermatology,
clinical microbiology, neurology etc.
SKILLS
|SOPs, validation |Analytical Skills |KOL, CRO and vendor |
|protocols and reports, | |interactions |
|annual reports etc. | | |
|Clinical overviews |Expense Control |Business Development |
|Word, Power Point, |Process Improvement|Communications |
|Adobe, Excel | | |
|AMA style, ICH guideline|Clinical Experience|Electronic Submissions|
|Clinical study |HIPPA Compliance |Scientific Medical |
|proposals, manuscripts, | |Writing |
|abstracts etc. | | |
|Proof-reading, |Quality Improvement|Various Therapeutic |
|fact-checking | |Areas |
|Editing, transparency |Process Improvement|Regulatory Support |
|Due diligence, Research |Customer Support |IND/NDA |
Professional Experience
Consultant 10/2010-Present
. Initiated a project to market biomarker that can predict response to anti-
viral treatments in HCV patients before or early in the treatment course.
. Initiated consultation with viral disease experts to implement
multicenter clinical trials on novel device that could identify all
patients exposed to these viruses using the current marketed kits.
Enzon Pharmaceuticals, Inc., Piscataway, NJ 1/2009-10/2010
RESEARCH SCIENTIST, ANALYTICAL DIVISION
. Involved in writing, compiling and submitting analytical regulatory
documents such as, validation protocols, validation reports and SOPs.
. Developed, validated & implemented cGMP methods. Involved in transfer of
the methods to cGMP CMOs & Partner QC dept.
. Performed quality control analyses of the recombinant proteins to support
process development & optimization, cGMP commercial manufacture, OOS
investigations and CMC activities for IND & BLA submissions.
. Prepared and submitted CMC regulatory documents according to ICH and FDA
guidelines.
. Designed, and executed all aseptic operations for the analytical division
to carry out various CMC tests as required by FDA on oncology and
immunology therapeutic proteins.
Accomplishments:
. Successfully prepared and submitted various regulatory documents
according to ICH guidelines.
. Managed and executed all aseptic operations for the analytical division.
. Successfully developed and validated SDS-PAGE, IEF and Residual host cell
DNA quantitation methods for 2 protein therapeutics and transferred to
CMO.
New York City Public Health Laboratories, New York, NY 12/2007-10/2008
CITY RESEARCH SCIENTIST II, VIROLOGY AND IMMUNOLOGY
. SUPERVISED HIV PCR LAB.
. Researched, wrote, provided and obtained approval for implementation of
HIV SOP.
. Developed, wrote and provided feasibility protocol and SOP for Herpes
Simplex Virus (HSV).
Accomplishments:
. Prepared feasibility protocol and SOP for HSV below the allotted time.
. Wrote and submitted three regulatory documents.
Laboratory Corporation of America, Raritan, NJ 10/2006-5/2007
MOLECULAR DIAGNOSTIC TECHNOLOGIST, PCR LAB
. PERFORMED HIGH VOLUME QUANTITATIVE HIV PCR TESTING OF BLOOD SAMPLES AND
REPORTING TO THE CLIENTS IN A MATRIX ENVIRONMENT SETTING.
. The tests performed were submitted for CLIA proficiency approval.
Accomplishments:
. CLIA Proficiency approval of HIV PCR tests.
Univ. of Medicine & Dentistry of New Jersey, Newark, NJ 10/1991-8/2006
SENIOR RESEARCH ASSOCIATE, DEPARTMENT OF MEDICINE
* RESPONSIBLE FOR DIAGNOSTICS AND RESEARCH OPERATIONS OF LIVER CENTER FOR
CLINICAL TRIALS.
* Researched, conceived and convinced which biomarkers to be used to screen
HCV patients who may not respond to anti-viral treatments. Initiated and
maintained collaborations with experts, performed lab investigations,
reviewed patients' clinical information, analyzed and correlated clinical
trial data/information with laboratory data. Drew conclusions, wrote,
communicated and published findings on Phrama-Transfer, Dialog in Drug
Discovery.
* In absence of any available resources for performing HCV research,
elucidated the mechanism of moderate to severe steatosis observed in HCV
genotype 3 patients. Initiated collaborations with in-house and NCI
bioinformatics scientists.
* Enrolled and successfully completed Fundamentals of bioinformatics
course. Analyzed all HCV amino acid sequences available in public
databases, hypothesized, proposed, investigated, wrote and published
research findings for funding and collaborations.
* In order to identify viral hepatitis patients enrolling at the liver
center, conceived, convinced, investigated, developed, implemented and
provided highly sensitive PCR assays for hepatitis viruses when no such
tests were commercially available within three months of joining with
very limited resources. Performed and supervised more than 2500 PCR
tests.
* Provided detailed technical support and guidance to national and
international scientists and physicians to set up diagnostic tests at
their organization.
* Helped 10 research fellows in their clinical research by providing
technical guidance and support.
Accomplishments:
. Pharma-Transfer posted the research proposal on line without any edition.
. Initiated liaison and collaboration with experts and thought leaders.
. Invited to initiate clinical trial collaboration by biotechnology company
officials.
. Requested to provide technical help & training for viral hepatitis
diagnostic services.
. The center received funding for the lab and salaries for personnel for
nearly 15years.
Consultant
SCIENTIFIC DIRECTOR/MEDICAL WRITER/REGULATORY CONSULTANT
. DEVELOPED QUESTIONS TO BE ADDRESSED TO THE EXPERTS FOR AN ANTIFUNGAL
PROJECT.
. Prepared scientific and medical writing for CME on a dermatological
project.
. Planned and implemented product development and validation support for a
medical device.
. Provided sterilization validation support for bulk manufacturing of
pharmaceutical product at a major pharmaceutical corporation.
Education & Professional Training
. Fundamentals of Bioinformatics, Informatics Institute of UMDNJ,
Piscataway, NJ
. Postdoctoral Associate and Asst Res Scientist, Northwestern, Texas A & M
and RWJMS
. PhD Microbiology, Indian Institute of Science, Bangalore, India
. MS Biochemistry, M. S. University of Baroda, Baroda, India
CERTIFICATIONS
. Addendum 1.
HONORS AND AWARDS
. Addendum 2.
TEACHING, TRAINING & MEDICAL/SCIENTIFIC WRITING EXPERIENCE
Addendum 3.
SELECTED PUBLICATIONS AND ABSTRACTS
. Addendum 4.
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