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Education

PhD in Pharmacology- 1995University of Colorado Health Sciences Center, Denver

BA in Microbiology- 1987Emphasis in Molecular GeneticsUniversity of California, Santa Barbara

 
Skills

  • Extensive experience in laboratory procedures, scientific research, and clinical environments

  • Thorough skills in scientific research methodologies: quality control, laboratory procedures, preparing records and official documentation, developing conclusions, publication and presentation of findings

  • Strong skills in medical and scientific writing: composition, grammar/syntax/sentence structure, credibility, comprehension and clarity

  • Solid editing and word processing skills: document organization, proofreading and rewriting, document formatting

  • Effective teaching experience including: conducting scientific lectures, seminars, and presentations; teaching/supervising laboratory personnel, medical and graduate students, and nurse practitioners

  • Sound experience with a wide variety of therapeutic areas

  • Expertise in client relations: satisfying needs, resolving problems, quality assurance, commitment to excellence

  • Fluent in French; experience in translating/rewriting research articles from French laboratories for publication in English journals

  • Excellent communication skills; proven interpersonal skil

 
Associations

Drug Information AssociationAmerican Medical Writers AssociationRegulatory Affairs Professionals Society

Experience

1999 to present

Freelance Medical Writer, Editor, and Translator 

  • Preparation of Clinical Study Reports (CSRs) and other documents for pharmaceutical companies

  • Assist in writing and/or translating scientific journal articles prepared by French/other foreign researchers

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2007 to 2010

Senior Medical WriterPPD Development, Inc., Morrisville, North Carolina 

  • Prepare clinical study reports, sections of Common Technical document, clinical trial protocols, and other regulatory documents

 

2008 to 2009

Co-InstructorThe Center for Professional Innovation and Education, Malvern, PA 

  • “The CTD/eCTD – Building the Marketing Application Throughout Clinical Development” – teach clinical and nonclinical portions of the course twice yearly

 

2006 to September 2007

Manager – Medical WritingSchwarzBioSciences, Inc., Raleigh, North Carolina 

  • Responsible for the mentoring and supervision of 3 junior medical writers

  • Fulfilled the functions described below for Senior Medical Writer

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2003 to 2006

Senior Medical WriterSchwarzBioSciences, Inc., Raleigh, North Carolina 

  • Served as the lead medical writer for the international clinical development program of a drug to treat pain associated with diabetic neuropathy

  • Supervised the medical writing activities and prepared documents in support of the neuropathic pain program including CSRs, protocols, regulatory documents (CTD sections, other submissions to regulatory authorities), and Investigator Brochures (IB) and updates

    • Involved in protocol development, clinical development program, attend regulatory agency meetings, review statistical and regulatory documents

    • Contributed to development of medical writing department including development of templates, standard operating procedure documents, and working practices

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2001 to 2003

Medical WriterPharmaNet, Inc., Cary, North Carolina 

  • Prepared CSRs and sections of clinical summary documents in the New Drug Application (NDA)

    • Interacted with the client regarding preparation of CSRs and represent Medical Writing at departmental and client meetings

    • Assisted in preparing protocols, abstracts, and other regulatory documents

    • Performed quality control review of medical writing documents ensuring adherence to established regulations and client guidelines

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1999 to 2001

Medical WriterPPD Development, Inc., Morrisville, North Carolina 

  • Interpreted data output and wrote clinical and statistical reports

    •  Wrote investigational drug brochures, and Investigational New Drug (IND) sections (preclinical and previous human experience)

    •  Wrote IND annual reports

    •  Consulted with sponsors to determine format, design, and direction of documents

    •  Edited and performed quality control review of documents prepared by other medical writers

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1998 to 1999Post-Doctoral Research FellowUniversity of Colorado Health Sciences Center, Denver, Colorado

  •  Researched the signal transduction pathways that regulate cell death in neurons

    •  ​Supervised graduate and college students

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1996 to 1998

Post-Doctoral Research FellowNational Institute for Health and Medical Research (INSERM), U145, Nice, France 

  • Researched the involvement of protein kinase B in insulin signal transduction

    •  Supervised a research technician and PhD student preparing for the equivalent of an American master’s degree

    •  Performed peer review of submitted journal articles

    •  Assisted foreign researchers (graduate students, post-doctoral fellows, etc) in writing of journal articles

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1995 to 1996

Post-Doctoral Research FellowVanderbilt University, Nashville, Tennessee 

  • Conducted research for cloning of human phospholipase D

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1990 to 1995

Graduate StudentUniversity of Colorado Health Sciences Center, Denver, Colorado

  • Thesis research focused on the characterization of annexins during differentiation of macrophages into cells capable of destroying cancer cells

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1989 to 1990

Research TechnicianCell Technology, Boulder, Colorado

  

1988 to 1990

Research Technician, University of Colorado Health Sciences Center, Denver, Colorado

 
Publications/Presentations

  • Filippa N, Sable CL, Hemmings BA, Van Obberghen E.  Effect of phosphoinositide dependent kinase 1 on protein kinase B translocation and its subsequent activation.  Mol Cell Biol 20: 1512-21, 2000.

  • Pugazhenthi S, Nesterova A, Sable C, Heidenreich KA, Boxer LM, Heasley LE, Reusch JE.  Akt/protein kinase B up-regulates Bcl-2 expression through cAMP-response element-binding protein.  J Biol Chem 275: 10761-6, 2000.

  • Pugazhenthi S, Miller E, Sable C, Young P, Heidenreich KA, Boxer LM, Reusch JE.  Insulin-like growth factor induces bcl-2 promoter through the transcription factor cAMP-response element-binding protein.  J Biol Chem 274: 27529-35, 1999.

  • Filippa N, Sable CL, Filloux C, Hemmings BA, Van Obberghen E.  Mechanism of protein kinase B activation by cAMP-dependent protein kinase.  Mol Cell Biol 19: 4989-5000, 1999.

  • Sable CL, Riches DWH.  Cloning and characterization of a novel transcript encoding a truncated annexin IV homolog from mouse macrophages.  Biochem Biophys Res Comm. 258: 162-7, 1999.

  • Sable CL, Remigio LK, Riches DWH.  Selective up-regulation of annexin IV during cytocidal activation of macrophages.  (Manuscript in preparation).

  • Sable CL, Shannon J, Riches DWH.  Cloning and selected tissue distribution of murine annexin IV.  (Manuscript in preparation).

  • Sable CL, Filippa N, Filloux C, Hemmings BA, Van Obberghen E.  Involvement of the PH domain in insulin-stimulated activation of protein kinase B.  J Biol Chem 273: 29600-29606, 1998.

  • Sable CL, Filippa N, Hemmings B, Van Obberghen E.  cAMP stimulates protein kinase B in a wortmannin-insensitive manner.  FEBS Lett 409: 253-257, 1997.

  • Malcolm KC, Sable CL, Elliott CM, Exton JH.  Enhanced phospholipase D activity and altered morphology in RhoA-overexpressing rat1 fibroblasts.  Biochem Biophys Res Comm 225: 514-519, 1996.

  • Laszlo DJ, Henson PM, Weinstein L, Remigio LK, Sable CL, Noble PW, Riches DWH.  Distinct pathways of macrophage differentiation in mouse macrophages.  Mutual exclusion of two phenotypic states.  Amer J Path 143: 587-597, 1993.

  • Gupta SK, Gallego C, Lowndes JM, Pleiman CM, Sable CL, Eisfelder BJ, Johnson GL.  Analysis of the fibroblast transforming potential of GTPase-deficient gip 2 oncogene.  Mol Cell Biol 12 190-197, 1992.

  • Carre PC, Mortenson RL, King TE, Jr., Noble PW, Sable CL, Riches DWH.  Increased expression of the interleukin-8 gene by alveolar macrophages in idiopathic pulmonary fibrosis.  J Clin Invest 88: 1802-1810, 1991.

  • Pritchard AE, Seilhamer JJ, Mahalingam R, Sable CL, Venuti SE, Cummings DJ.  Nucleotide sequence of the mitrochondrial genome of Paramecium.  Nucl Acids Res 18: 173-180, 1990.

  • Pritchard AE, Sable CL, Venuti SE, Cummings DJ.  Analysis of NADH dehydrogenase proteins, ATPase subunit 9, cytochrome b, and ribosomal protein L14 encoded in the mitochondrial DNA of Paramecium.  Nucl Acids Res 18: 163-171, 1990.

  • Pritchard AE, Venuti SE, Ghalambor MA, Sable CL, Cummings DJ.  An unusual region of Paramecium mitochondrial DNA containing chloroplast-like genes.  Gene, 78: 121-134, 1989.

Awards

Poste Verte Research Fellowship from INSERM, 1996 – 1998

Upjohn Research Award for Excellence in Graduate Study, December 1991

Carol Sable, PhD

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