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Medical and Clinical Writer

Location:
Pittsburgh, PA, 15238
Salary:
67000
Posted:
October 27, 2015

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Resume:

Michelle L. Jones, PhD

*** ****** ***** *****

Pittsburgh, Pennsylvania 15238

412-***-****

acr8gr@r.postjobfree.com

SUMMARY

Biopharmaceutical and medical device industry professional with 7+ years of diverse experience in medical, clinical, and scientific writing; clinical trial management; and team leadership. Consistently recognized for outstanding writing and communication skills and client relationship management. Planned, executed, and led successful multi-disciplinary projects, including clinical studies and biomodeling projects.

EXPERIENCE

Freelance Work

• Document Consultant, University of Pittsburgh Advanced Computing Technologies Laboratory, Pittsburgh, Pennsylvania

February 2015 – Present

o Reviews technical abstracts, white papers, conference papers, and journal publications for language and content

o Reviews engineering dissertations for language, content, and readability

• Grant Writing Consultant, University of Pittsburgh Advanced Computing Technologies Laboratory, Pittsburgh, Pennsylvania

February 2015 – Present

o Leads collaborative preparation of Small Business Innovation Research and R03/R21 proposals for submission to National Institutes of Health and National Science Foundation.

§ Assists in organizing and structuring cross-disciplinary (medicine and engineering) proposals

§ Ensures that research proposals maintain internal logic and consistency and meet submission requirements

§ Manages timelines for writing deliverables and proposal submission

§ Designs and edits data and schematic figures

§ Writes proposal content suitable for multiple audiences Clinical Research and Publications Manager, ZOLL, Pittsburgh, Pennsylvania August 2013 – January 2015

CLINICAL RESEARCH AND WRITING

• Collaborated on writing and revision of study protocols, informed consent forms, case report forms, Investigator’s Brochures, and department-wide standard operating procedures

• Developed and wrote marketing materials, monitoring plans, clinical study training materials, ClinicalTrials.gov postings, and essential clinical study documents

• Developed, wrote, and oversaw generation of technical reports and clinical data summaries, and performed quantitative analyses for clinical trial

• Developed and wrote clinical study data management plan used as a training standard for other company departments

• Pioneered departmental use of electronic document management system Michelle L. Jones, PhD

• Initiated and managed global, multi-site clinical validation study of enhanced medical device features

• Collaboratively worked with multiple functions (Medical Affairs, Marketing, Engineering, Clinical Operations, Data Management, Client Relations) to develop and execute strategy, scope, operations, and timeline for clinical study

• Managed training and daily project activities of clinical research associates, contractors, and junior staff

PUBLICATION MANAGEMENT

• Led communication with key opinion leaders, academic investigators, and multiple internal departments to plan and implement global publication strategies

• Oversaw submission of medical, scientific, and technical publications, including: o Manuscripts to major journals: Heart Rhythm, Journal of the American Medical Association, Journal of the American College of Cardiology o Abstracts to international conferences: American Heart Association, Heart Rhythm Society, European Society of Cardiology, American College of Cardiology

• Collaborated on writing and editing of manuscripts, abstracts, posters, and oral presentations

Research Scientist Project Lead, Immunetrics, Inc., Pittsburgh, Pennsylvania October 2010 – August 2013

CLINICAL RESEARCH AND WRITING

• Used targeted literature searches to research wide-ranging clinical topics. Documents were consistently recognized as focused, informative, and clearly written.

• Performed in-depth analysis of published and proprietary pharmaceutical clinical trial data from all phases, including PD/PD and efficacy data o Used clinical data mining and querying of databases (SQL) o Prepared clinical data summaries for use by multi-functional modeling team

• Wrote medical research summaries serving as scientific foundation for mechanistic models of chronic and acute inflammation

• Worked with multi-functional team to develop sophisticated predictive models that drove pharmaceutical clients’ decisions regarding drug development strategy PROJECT MANAGEMENT

• Managed design, planning, and completion of a long-term, multi-phase rheumatoid arthritis project with a major pharmaceutical company

• Played key role in securing new contracts with existing and new pharmaceutical clients.

• Led client meetings and day-to-day client relationship management

• Developed project plans, specifications, pitches, and proposals with long- and short-term milestones and deliverables, and ensured project timelines were met

• Actively pursued process improvements and facilitated communication within multi- disciplinary team, enhancing productivity and achieving project goals

• Responsible for final scientific decisions related to biological model COMMUNICATIONS

• Prepared marketing documents, project proposals, audiovisual materials (technical and marketing), technical reports, and abstracts for clients and regulatory agencies (FDA)

• Principal author of technical copy appearing on corporate website

• Designed and authored training programs and managed training of new team members and junior staff

Michelle L. Jones, PhD

Research Scientist (Biological Modeler), Immunetrics, Inc., Pittsburgh, Pennsylvania January 2008 - October 2010

• Proactively developed expanded skill set in bioengineering and mechanistic modeling to support work of the modeling team, leading to promotion to Project Lead

• Developed sophisticated biological models of chronic and acute inflammation, collaborating on model design with mathematical modeling team

• Wrote medical research documents serving as scientific foundation for mechanistic models.

• Synthesized technical information for the diverse knowledge set of team and client

• Analyzed published clinical trial data and pharmaceutical client trial data from all phases, including PK/PD and efficacy data. Prepared clinical data summaries and developed plan for using trial data to calibrate models

Instructor, Penn State New Kensington, New Kensington, Pennsylvania January 2008 - June 2008

Taught Biological Sciences 004 – Human Body Form and Function

• Developed syllabus and course materials for human physiology survey course

• Designed innovative and non-traditional class projects, making biology accessible and appealing to non-science majors

Postdoctoral Fellow, Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania June 2005 – December 2007

Recipient of NIH National Research Service Award Fellowship – September 2006

• Investigated tryptophan hydroxylase as a driver of serotonin production using C.elegans as a model organism

• Wrote and edited research grants, abstracts, posters, and peer-reviewed publications

• Supported research on depression and post-traumatic stress disorder Teaching Assistant, Department of Biology, University of Illinois at Chicago, Chicago, Illinois August 1999 - May 2003

• Lectured, conducted problem and review sessions, and administered laboratory classes

• Designed, administered, and graded homework problems, quizzes, and exams Courses: Biology 100: Biology of Cells and Organisms Biology 101: Biology of Populations and Communities Biology 103: Human Development and Reproduction

Biology 220: Mendelian and Molecular Genetics

Biology 221: Genetics Laboratory

Biology 443: Animal Physiological Systems

EDUCATION

Ph.D., Neurobiology, 2005

University of Illinois at Chicago, Chicago, Illinois Dissertation: Insulin-mediated modulation of NMDA receptor currents in Xenopus oocytes B.S., Biology, 1999

College of William and Mary, Williamsburg, Virginia Michelle L. Jones, PhD

PUBLICATIONS

Papers

Jones, M.L., and Leonard, J.P.: PKC site mutations reveal differential modulation by insulin of NMDA receptors containing NR2A or NR2B subunits. J. Neurochem. 92: 1431-1438, 2005.

• Contribution: Experimental design, execution, and analysis; lead writer Jones, M.L., Liao, G.Y., and Leonard, J.P: PI 3-Kinase activation of PKCζ mediates insulin- induced potentiation of NMDA receptor currents in Xenopus oocytes. Brain Research 1432: 7-14, 2012.

• Contribution: Experimental design, execution, and analysis; lead writer Zubenko, G.S., Jones, M.L., Estevez, A.O., Hughes, H. B. 3rd, and Estevez, M.: Identification of a CREB-dependent serotonergic pathway and neuronal circuit regulating foraging behavior in Caenorhabditis elegans: a useful model for mental disorders and their treatments?. Am J Med Genet B Neuropsychiatr Genet. 150B(1): 12-23, 2009

• Contribution: Experimental design, execution, and analysis; collaborating writer Poster presentations

Jones, M. L., Hsu, M. H. and Leonard, J. P. Insulin-Mediated Modulation of NMDA Receptors through PKC Sites.

Society for Neuroscience Annual Meeting, 2001

Jones, M. L., and Leonard, J. P. Insulin-Mediated Modulation of NMDA Receptors through PKC Sites and a Calcium-Dependent Tyrosine Kinase.

Society for Neuroscience Annual Meeting, 2003

Jones, M.L., Estevez, A. O., and Estevez, M. The Serotonin Receptor SER-4 is Involved in Feedback Regulation of Serotonin Synthesis.

University of Pittsburgh Science 2005 Meeting, 2005 Jones, M.L., Estevez, A. O. and Estevez, M. The Serotonin Receptor SER-4 is Involved in Feedback Regulation of Serotonin Synthesis

C. Elegans Meeting: Neuronal Development, Synaptic Function, and Behavior, 2006 Invited Presentations

Jones, M. L. Insulin-Mediated Modulation of NMDA Receptor Currents in Xenopus Oocytes, Laboratory of Molecular Biology Student and PostDoc Seminar Series, 2001, 2003, 2004 Jones, M. L. Insulin Modulation of NMDA Receptor Currents in Xenopus Oocytes, Sigma Xi Graduate Scientific Research Society Graduate Student Forum, 2002, 2003 Jones, M. L. Regulation of the C. elegans Tryptophan Hydroxylase Gene Through a 5HT- Receptor Cascade

University of Pittsburgh Signaling Club Seminar Series, 2006 Jones, M. L. Regulation of the C. elegans Tryptophan Hydroxylase Gene Through a 5HT- Receptor Cascade

University of Pittsburgh C. elegans Meeting, 2006

Michelle L. Jones, PhD

Jones, M. L. Regulation of C. elegans Tryptophan Hydroxylase Expression by Signaling Through the SER-4 Serotonin Receptor and CREB

University of Pittsburgh Department of Neurology Training in the Neurobiology of Psychiatric Disorders Meeting, 2007

HONORS

NIH NRSA Training in the Neurobiology of Psychiatric Disorders Award Recipient, 2006 James Monroe Scholar, College of William and Mary, 1995-1999 PROFESSIONAL SOCIETIES

Society for Neuroscience, Student member, 2001-2005 Women in Bio - Pittsburgh Chapter, Member, 2013-present



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