Scientific/Medical Writer

Joseph J. Shaw, PhD ELS

•Germantown, MD • cell: 936-***-**** • ********@*****.***

Senior Scientific and Medical Writer

A scientific medical writer with more than 25 years of experience in biological, biomedical, and biotechnological sciences with deep expertise writing regulatory documents, scientific updates, manuscripts, white papers, capture/funding proposals, SOPs, and training materials; Proficient in AMA and CSE styles; Ability to mine proprietary and public databases and distill information for all audiences using federal government guidelines for plain language where required.

CORE COMPETENCIES

• Scientific Editor/Writer (ELS) • Biotechnology Research Reports • Scientific Manuscripts

• Study Reports (Modules 2 & 4) • Capture/Funding Proposals • Write for any Audience

•Public Trust Clearance (Secret elig.) • Mine Mammalian Genome• Data Mining, incl. Gray Lit.

PROFESSIONAL EXPERIENCE

Shaw Resources, Germantown, MD 2012 – Present

Privately held scientific and writing and consulting group in support of biotech and other industries

Scientific Writer

Responsible for database searching and information retrieval and writing, editing, and proofreading documents to include SOPs, manuscripts, brochures, and biomedical/biotechnological information

• Developed and wrote biological narrative proposal for funding to federal agencies

• Wrote multi-disciplinary congressional reports, meeting minutes, correspondences, and White Papers for the Department of the Interior (BOEM [YRCI]), the National Institutes of Health (NCS [Astrix]), and Walter Reed National Military Medical Center (GDIT)

• Wrote or performed substantive edits on 15+ manuscripts/reports on biotechnology, microbiology, biomedicine, and other topics

• Authored 2 white papers on emerging energy research areas

ClinicalRM, Frederick, MD 2010 – 2012

A full-service CRO specializing in support of biotechnological, clinical research, and information services for biologics, drugs and devices, and techniques

Scientific Writer (contractor in support of US Army Medical Research Institute of Infectious Disease [USAMRIID], Virology Division)

Responsible for writing scientific documents, posters, and oral presentations including graphs, tables, and composite figures using data provided by researchers; editing grant proposals for federal funding agencies; performing statistical analyses of experimental data; mining scientific, public, and news databases to recover and analyze information needed for writing; working with SMEs to write progress reports for federal funding agencies

• Wrote Animal Model Qualification submission base document for the purpose of developing therapeutics for biodefense

• Wrote, edited, or prepared 4 scientific manuscripts and posters, 4 oral presentations, and 5 quad charts

• Prepared 4+ progress reports for military funding agencies (DITRA)

• Performed 50+ statistical analyses of experimental data inclusive of t tests, repeated measures tests, homogeneity of variance, and related tests

• Mined scientific and public databases that proved critical in capturing hundreds of documents and reports in support of writing

Medimmune, Gaithersburg, MD 2008 – 2010

A global biologics immunization research, development, and manufacturing firm

Scientific and Non-Clinical Medical Writer

Responsible for writing non-clinical modules 2 and 4 for INDs, IBs, IMPDs, response letters, orphan drug applications, input to annual reports, scientific documents, and providing substantive edits to scientific documents, coordinating projects with Regulatory Affairs, Publication Planning and Research (immune disorders, vaccines, infectious diseases, oncology, orphan diseases for biologics), and teaching in-house writing courses for teammates

• Wrote 5+ scientific manuscripts and posters over 3 years

• Prepared 70+ study reports for nonclinical portions of INDs, IMPDs, and IBs

• Team lead for 15+ Scientific Writing projects representing numerous INDs and IMPDs

• Taught 5+ in-house writing courses and trained more than 25 scientific/technical writers in scientific/technical writing

• Represented team on TARDIS (Documentum) rollout

Lexicon Pharmaceuticals, Inc., The Woodlands, TX 2000 – 2008

A global biopharmaceutical firm engaged in developing breakthrough treatments for human disease

Senior Editor for Scientific Publications (2004 – 2008)

Responsible for publication planning, writing, and editing scientific manuscripts, in-house white papers, posters, and oral presentations in support of staff scientists and in collaboration with the Research and Communications Departments

• Wrote 100+ documents describing the phenotypes of knockout mice

• Wrote or edited 15+ formal scientific publications

• Researched and wrote 4+ grant proposals (Shipley-like process) with 50% success

• Edited more 20+ scientific manuscripts and posters for staff scientists

• Wrote 15+ in house white papers about predicted gene/protein function for orphan genes

Genome Curator (2000 – 2004)

Responsible for finding and identifying genes of interest in mouse and human genomes and established mouse-human orthology; supported other scientists in gene annotation, use of genomic and protein databases, scientific writing, and technical software training

• Mined mouse genome for 1000+ genes of pharmaceutical interest (before genome was annotated)

• Co-submitted 200+ mouse mRNA sequences to NCBI

• Wrote 500+ reports with supporting evidence about pharmaceutical interest for identified genes

• Led the implementation and training of scientific software tools such as Pathway Analysis, multiple sequence alignment software, ProSite, KEGG, and related tools

University of Scranton, Scranton, PA 1998 – 2000

A private non-profit university with majors in biological and social sciences

Computational/Informational Scientist

Responsible for writing grant submissions and implementation, germplasm collection and analysis, progress reporting and interfacing with government-funded scientists within DARPA, EPA, NIH and other agencies, and one-on-one teaching

• Wrote 4+ grant submissions concerning microbial genomics, detection of microbes, mass spectrometry of plant pathogens (50% success)

• Wrote 5+ scientific manuscripts

• Assembled, mapped, and annotated 60 kb microbial plasmid of Haloferax volcanii

• Taught 10+ graduate and undergraduate students biology and molecular biology

EARLIER EXPERIENCE AND EMPLOYMENT

Assistant/Associate Professor, 1988-1998; Auburn University, AL, Depart of Department of Botany & Microbiology; research on microbial genetics, plant molecular biology, teaching molecular biology, etc.

• Established the graduate/undergraduate program in molecular biology

• Taught botany, microbiology, and general biology

• Wrote 30+ scientific manuscripts and book chapters

• Funded own research programs in molecular biology and microbial ecology with competitive grants

• Trained 10+ graduate students for MS and PhD degrees

• Taught English as a second language for graduate students

• Participated in Extension Classes

Visiting Professor, 1996–1998; Bacteriology Clinical Reference Laboratory, Brooks Air Force Base, San Antonio, TX (two-year appointment concurrent with appointment at Auburn University)

Guest Graduate Instructor, 1996, 1997, (two-week courses in bacterial ecology, concurrent with other appointments) Huazhong University of Science & Technology, Wuhan, China

EDUCATION

University California Davis, Davis, CA

• Doctorate, Emphasis: molecular biology of plant diseases

University California Santa Barbara, Santa Barbara, CA

• Bachelor of Arts, Botany/Biology

PROFESSIONAL DEVELOPMENT

• Editor in the Life Sciences (ELS, accredited by Board of Editors in the Life Sciences), 2010

• Good Laboratory Practices (GLP) course, Ft. Detrick, MD, 2011

• Multiple writing courses and workshops

TECHNICAL SKILLS

• Acrobat, Microsoft Word (2007, 2010, 2013), Excel, PowerPoint, Outlook, Publisher, Endnote, SharePoint (WYSIWYG), NCBI PubMed, LexisNexis, Ovid, BLAST, Gene, Entrez; GraphPad Prism, SnagIt, Documentum (with software interface), WordPress (WYSIWYG), Internet searches including gray literature databases (e.g., Williams College Databases)

PROFESSIONAL AND VOLUNTEER ORGANIZATIONS

• Lions Club

• Memberships in TIPPA, AMWA and Council of Science Editors

HONORS AND AWARDS

• Graduated with highest honors (UCSB)

• Regents Fellowship (UCD)

• McKnight Fellowship (UCD)

SELECTED - PUBLICATIONS, CONTRIBUTIONS, AND ARTICLES

In Preparation

Shaw, J.J. et al., in preparation. Review of Rhesus Macaque as an Experimental Model for Ebola Fever

Shaw, J.J. et al., Health Effects of Sound and Other Factors from Operational Wind Turbines, 2015 (in preparation)

Peer Reviewed Articles

Zambrowicz B.P., Abuin A., Ramirez-Solis R., Richter L.J., Piggott J., BeltrandelRio H., Buxton E.C., Edwards J., Finch R.A., Friddle C.J., Gupta A., Hansen G., Hu Y., Huang W., Jaing C., Key B.W. Jr, Kipp P., Kohlhauff B., Ma Z.Q., Markesich D., Payne R., Potter D.G., Qian N, Shaw J.J., Schrick J., Shi Z.Z., Sparks M.J., Van Sligtenhorst I., Vogel P., Walke W., Xu N., Zhu Q., Person C., and Sands A.T. 2003. Wnk1 kinase deficiency lowers blood pressure in mice: a gene-trap screen to identify potential targets for therapeutic intervention. Proc Natl Acad Sci U S A. 100(24):14109-14

DelVecchio, V.G., Rose S, and Shaw J.J. 1998. Rapid detection of enterococci and antibiotic resistance genes in urine: approaching real-time capability. Clin Microbiol Newsl 20:192-194

Shaw, J.J., F.K. McCleskey, K. Beninga, W. Candler R.J. Redkar, V.G. DelVecchio, and M.T. Goode. 1998. Rapid Detection of tularemia with real-time PCR. Infec in Med 15:326-330

Book Chapters, Proceedings, and Contributed Publications

Shaw, J.J., Brown A.E, Singh N.P., Wu S-J., and Dane F. 1997. Antibiotic, Chromogenic, and Luminescent Markers for Bacteria, In Manual of Environmental Microbiology, C. Hurst, G. Knudsen, M. McInerney, L. Stetsenbach, M Walter (eds.) ASM Press, Wash. DC. pp.466-472

Wu, S.-J., Wu J. and Shaw J.J. 1997. DNA solutions of weighted cycle searchingproblems J Ala Acad Sci 68(3): 259- 271

Dane, F. and Shaw, J.J. 1996. Bioluminescence in plant- pathogenic bacteria. Recent developments in Plant Pathology. Research Signpost. (S.G. Pandalai, ed). India

Professional Contributions

Senior Editor, Microbial Releases, a scientific journal devoted to the planned use of microbes in the environment (Springer-Verlag, Heidelberg), 1991-1994

Guest editor for Plant Molecular Biology, 1992-1996

Selected to host visiting scientist funded by the Organization for Economic Cooperation and Development (OECD) for 8 weeks, to study technology invented in my laboratory to monitor genetically engineered microbes introduced into the environment, 1991

Guest editor for BioTechniques in the areas of bioluminescence, microbiology and plant molecular biology, 1990- 1996

Invited Presentations

Shaw J.J., E. Brown E, Smith K, Hensley L, Shoemaker D, 2011. Facilitating. Food and Drug Administration (FDA) Approval of Candidate Medical Countermeasures Against Biowarfare Agents: Formal Qualification of Animal Models for Ebola Hemorrhagic Fever, Chemical and Biological Defense Science and Technology Conference, Las Vegas

Shaw, J.J. 1998. DNA Molecules for Computational Problems, Inst. Molecular Biology& Medicine, University of Scranton, Scranton PA

Shaw, J.J. 1998. Life in the Republic of China, Issues Related to Health, EpidemiologicalServices Division, Brooks Air Force Base, San Antonio TX

Shaw. J.J. 1996. Reporter Genes, Molecular Biology and Science. BiologyDepartment. Stonehill College, N. Easton MA

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