Medical Writer Caldwell, Susan, PhD

Current

• Medical Writer Consultant and President at Biotech Ink, LLC

Past

• Senior Associate, Medical Writing, at Raland Technologies, LLC
• Medical Writer Consultant at Scios, Inc. (Johnson & Johnson company)
• Senior Director of Writing and Publishing at ICON Clinical Research

• Director, Medical Writing at Abgenix, Inc.
• Technical Writing Consultant (Self-employed)
• Director, Technical Writing at Pharmacyclics, Inc.
• Associate Director, Medical Writing at Berlex Laboratories
• Partner at BioInformation Resources
• Senior Scientist at Baxter Healthcare
• Scientist II, Scientist I at Genelabs, Incorporated

see less...

7 more...

Education

• Wake Forest University School of Medicine
• Wake Forest University School of Medicine
• University of Tennessee-Knoxville

• Jefferson High School

see less...

1 more...

Recommended

7 people have recommended Medical Writer

Connections

313 connections

Industry

Biotechnology

Websites

• My Blog

Medical Writer Caldwell, Susan, PhD’s Summary

Experience: As a PhD scientist with research training in human infectious diseases, performed lab research for 10 years. Since then, directed medical writing departments at 5 life-science companies. Published (samples available on request) numerous medical articles, book chapters, web content, and newsletters. Work experience and medical and scientific publications demonstrate a rare combination of medical knowledge, analytical skills, and writing experience. Clinical areas of writing expertise include oncology, cardiology, pediatric/adult neurology, infectious diseases, drug safety, and more. Examples include GBM, brain metastases, squamous cell carcinoma, NSCLC, atherosclerosis, CGD, Crohn’s disease, AMD, neutropenia, influenza, HBV and HCV infection, HIV/AIDS, CHF, CAD, and GVHD.
* Wrote/reviewed submissions, protocols, study reports, IBs, process development reports, CMC and GXP audit reports, manuscripts, and other document types.
* As Director/Senior Director, managed writers at five biotech/device companies; supervised many medical writers and consultants.
* Performed quality checks (QC) on a wide range of research, clinical drug development, process development, and CMC documents.
* Acquired deep experience in developing infrastructure support (eg, templates, SOPs, style guides) for writing tasks in drug/device development.
* Currently provide hands-on writing services as a consultant with Biotech Ink, LLC.
* Strong publication record in the peer-reviewed biomedical literature, and presentations at many medical conferences.
* Publish a weekly jobs newsletter for medical writers, the Biotech Ink Insider (www.biotechinkinsider.com).
* See these reference resources: LinkedIn.com profile and recommendations for Susan Caldwell at www.linkedin.com/in/biotechink; references (in addition to those posted at www.linkedin.com/in/biotechink) available on request; career experience map at www.jobfox.com/Web/Seeker/EditMyPortfolio.aspx.

Medical Writer Caldwell, Susan, PhD’s Specialties:

Expert medical writer for biotech, pharmaceutical, medical device, and related industries. Deep experience with submissions (eg, eCTDs, BLAs, NDAs, PMAs, and INDs); manuscripts; GXP documents, audit reports; QC services for many types of clinical and manufacturing documents; SOPs, templates, and style guides; and formatting for publication (including hyperlinks, bookmarks, captions, and cross-references). Other experience: web content, tech writing, copyediting, newsletters, white papers.

Medical Writer Caldwell, Susan, PhD’s Experience

• Medical Writer Consultant and President

  Biotech Ink, LLC

  (Privately Held; Writing and Editing industry)

  January 2005 — Present (4 years 11 months)

  As principal writer and president, offer comprehensive writing, editing, reviewing, proofreading, word processing, and document formatting services, primarily for the life-science industries.
  
  Also give clients access to expert writers, editors, and proofreaders. Write, review, and direct writing teams to ensure quality work product and on-time delivery.
  
  Medical writing: Write eCTDs; protocols, CSRs, and IBs; CMC documents; manuscripts; and PK/tox reports. Write manuscripts, tables, and figures; abstracts; posters; slides.
  
  Other writing services: Develop web content, including blog articles; white papers; brochures; newsletters; resumes; and marketing pieces.
  
  Publishing: Publish the Biotech Ink Insider (http://www.biotechinkinsider.com), a free weekly newsletter. Focus is on open staff and contract jobs and career information for medical writers, editors, and professionals in related positions

• Senior Associate, Medical Writing,

  Raland Technologies, LLC

  (Biotechnology industry)

  December 2008 — May 2009 (6 months)

  Provided medical writing and editing services to client company. Project was eCTD/NDA submission; contributions included development of submission content, style guide, and ICH-compliant eCTD templates.

• Medical Writer Consultant

  Scios, Inc. (Johnson & Johnson company)

  (Public Company; 501-1000 employees; Biotechnology industry)

  April 2005 — July 2005 (4 months)

  Provided medical writing services to support the research and development of drug products. Drafted, reviewed, and revised clinical study documentation, including protocols, amendments, investigator brochures, and study reports.

• Senior Director of Writing and Publishing

  ICON Clinical Research

  (Public Company; 1001-5000 employees; Biotechnology industry)

  February 2004 — January 2005 (1 year )

  Expanded medical and technical writing and publishing services for the fourth-largest clinical research organization (CRO). Directed activities of writers and submissions publisher. Supported US clients with study documents for phase 1 through 4 clinical studies. Clinical disciplines included, but were not limited to, cardiovascular, oncology, infectious diseases, inflammatory diseases, diabetes, and analgesia. Nonclinical areas included pharmacokinetics, toxicology, pharmacology, and CMC.
  
  Medical writing: wrote, edited, revised, and reviewed clinical regulatory documents, including clinical study protocols and reports; investigator brochures; SAE narratives; informed consent forms; and two CTDs (one hard copy, one electronic). Also wrote meeting abstracts, slide presentations, posters, and biomedical manuscripts.
  
  Technical writing: developed process development and CMC documentation for two CTD submissions.

• Director, Medical Writing

  Abgenix, Inc.

  (Public Company; 501-1000 employees; ABGX; Biotechnology industry)

  June 2002 — January 2004 (1 year 8 months)

  Clinical disciplines included oncology (renal cell, NSCLC, colorectal, breast, pancreatic, and prostate), inflammatory diseases (GVHD, psoriasis, COPD), and fully human monoclonal antibody technology.
  
  Medical writing: wrote and edited clinical regulatory documents and journal articles, the company's style guide, slide kits, and executive summaries; wrote and edited press releases; provided scientific writing services for Process Development reports and protocols. Generated abstracts, posters, and slide presentations for medical conferences.
  
  Technical writing: developed Internet and intranet site content.
  
  Infrastructure: developed infrastructure (eg, SOPs, templates, and checklists) to support medical writing; helped implement Documentum (EDMS) software; member, Biosafety Committee.
  
  Publishing: published clinical study reports for esubmissions (eg, hyperlinking, cross-referencing, paginating, and processing scanned documents for esubmissions) with ISIToolbox.

• Technical Writing Consultant

  Self-employed

  (Self-Employed; Myself Only; Biotechnology industry)

  June 2003 — September 2003 (4 months)

  Provided technical writing services to support the development of computer validation plans for a major biotechnology company.

• Director, Technical Writing

  Pharmacyclics, Inc.

  (Public Company; 51-200 employees; PCYC; Biotechnology industry)

  January 1999 — May 2002 (3 years 5 months)

  Director, Technical Writing, Jan 2000-May 2002
  Pharmacyclics, Inc; Sunnyvale, CA
  Clinical disciplines included cardiology, oncology (brain metastases, squamous cell carcinoma of the head and neck, and glioblastoma multiforme), and age-related macular degeneration.
  
  Medical writing: wrote, edited, and reviewed documents, including clinical study protocols, amendments, and reports; investigator brochures; package inserts; PK reports; medical journal articles; mock NDA; press releases; slide kits; abstracts, posters, and presentations; and a style guide.
  
  Technical writing: wrote and edited SOPs, working guidelines, MSDSs, and stability reports.
  
  Infrastructure: ensured staff received training (eg, CoreDossier, Documentum, Adobe Acrobat); developed processes to facilitate document production; helped implement Documentum (EDMS) and CoreDossier (electronic publishing software); supervised Reference Manager database development; directed medical writing intranet site development.

• Associate Director, Medical Writing

  Berlex Laboratories

  (Public Company; 1001-5000 employees; Biotechnology industry)

  September 1995 — January 1999 (3 years 5 months)

  Associate Director of Medical Writing, 1995-1999
  Berlex Laboratories; Richmond, CA
  Clinical areas included multiple sclerosis, oncology (leukemia), and MRI contrast agents.
  
  Medical writing: wrote and edited Summary Basis for Approval, Integrated Safety Summary, Integrated Efficacy Summary, package insert, serious adverse event narratives, investigator brochure, and supplemental BLA for Betaseron®; drafted manuscripts; wrote clinical study reports and created meeting abstracts and slide presentations; prepared study reports and SAE narratives for Postmarketing.
  
  Technical writing: developed CMC and Process Development documentation and stability study reports.
  
  Infrastructure: wrote, edited, reviewed, and approved SOPs for Clinical Research and Process Development; participated in implementation and configuration of Documentum (EDMS) and CoreDossier (epublishing software).
  
  Publishing: published electronic BLA for Betaseron® using CoreDossier, Adobe Acrobat, and Documentum.

• Partner

  BioInformation Resources

  (Partnership; 1-10 employees; Market Research industry)

  February 1993 — August 1995 (2 years 7 months)

  Owned and operated BioInformation Resources. Specialized in biomedical information research from online databases. Analyzed information and wrote reports for clients. Performed competitive intelligence and market analysis for pharmaceutical companies. Projected pharmaceutical and biotechnology industry trends. Obtained patent and product liability data and documentation for lawsuits with medical subjects.

• Senior Scientist

  Baxter Healthcare

  (Public Company; 10,001 or more employees; BAX; Medical Devices industry)

  January 1991 — February 1993 (2 years 2 months)

  Wrote regulatory documents, including PMAs, for diagnostic devices for infectious diseases (eg, acute hepatitis A virus infection). Coordinated and managed clinical trials. Wrote clinical trial protocols and final reports. Generated database of trial results and analyzed the data. Chaired meetings to coordinate clinical trials, and analyzed and presented clinical study data to project team. Developed diagnostics assay for acute hepatitis A virus infection. Co-chaired Biosafety Committee, and served on Management Safety Committee. Brought BL-3 laboratory into cGMP compliance, and supervised its operations. Wrote clinical regulatory and CMC documents and SOPs to support assay’s manufacture, and directed assay's manufacture. Performed quality checks on other writers’ documentation. Supervised 2 technicians.

• Scientist II, Scientist I

  Genelabs, Incorporated

  (Public Company; 51-200 employees; Biotechnology industry)

  September 1987 — December 1990 (3 years 4 months)

  Directed phase 1 clinical trial support for GLQ223®. Generated data in an IND for GLQ223®, a drug with antiviral activity against HIV. Screened substances for antiviral activity. Wrote portions of patents, INDs, manuscripts for publication, SOPs, and procedures. Coordinated phase 1 trial support between Medical Affairs, Pharmaceutical Development, QA and QC, and Regulatory Affairs. Presented data at meetings. Supervised 5 technicians and operations of a BL-3 containment laboratory. Served as Biosafety Officer.

Medical Writer Caldwell, Susan, PhD’s Education

• Wake Forest University School of Medicine

  Postdoctoral Fellowship , Internal Medicine, Section on Infectious Diseases , 1983 — 1987

  Postdoctoral research in the Dept of Medicine, Section on Infectious Diseases. Studied the characteristics of human neutrophil (PMN) NADPH oxidase activity during in vitro bacterial or viral infection. Cells were purified from humans who had infections (influenza virus or bacterial), or were derived from patients who had leukemia, chronic granulomatous disease (CGD), or other pathologies affecting cell functions. Identified and characterized a 48-kilodalton marker protein and alterations in protein kinase C activity that were associated with impaired PMN function during infection. Demonstrated altered protein phosphorylation in PMN infected with influenza virus or derived from a patient with CGD.

  Activities and Societies:

  Sample Publications:
  
  Lyles D, Bowen H, and CALDWELL S. 1981. In: The Replication of Negative Strand RNA Viruses. DHL Bishop and RW Compans, eds. Elsevier North Holland, New York, pp 559-565.
  
  CALDWELL S and Lyles D. 1986. J Virol 57:678-683.
  
  CALDWELL S, McCall C, Hendricks C, et al. 1988. J Clin Invest 81:1485-1496.
  
  CALDWELL S, Cassidy L, and Abramson J. 1988. J Immunol 140:3560-3567.
  
  McGrath M, Huang K, CALDWELL S, et al. 1989. Proc Natl Acad Sci, USA 86:2844-2848.

• Wake Forest University School of Medicine

  PhD , Medical Microbiology and Immunology , 1978 — 1982

  Medical Virology major, Protein Biochemistry minor.
  
  Teaching experience: taught medical microbiology, medical virology, and medical immunology to medical student classes.

  Activities and Societies:

  Sample Publications:
  
  ROACH (nee' CALDWELL) S and Lyles D. 1980. Abs Ann Mtg Amer Soc Microbiol, p 265.
  
  CALDWELL S and Lyles D. 1981. J Biol Chem 256:4838-4842.
  
  Lyles D, Bowen H, and CALDWELL S. 1981. In: The Replication of Negative Strand RNA Viruses. DHL Bishop and RW Compans, eds. Elsevier North Holland, New York, pp 559-565.
  
  Dissertation Title: Interactions of viral proteins with the cytoplasmic surface of cell membranes

• University of Tennessee-Knoxville

  BA , Biology , 1976 — 1978

  Activities and Societies:

  Graduated with Honors in Biology.

• Jefferson High School

  HS , 1966 — 1970

Additional Information

Medical Writer Caldwell, Susan, PhD’s Websites:

• My Blog

Medical Writer Caldwell, Susan, PhD’s Interests:

• Cutting-edge medical and scientific information • New drugs and medical devices in development • Medical writing • Scientific and technical writing • Web content writing • Writing and publishing technologies • Creative consulting arrangements • Translating technical medical information into concepts understandable by laypersons • Biotech Ink Insider job newsletter (http://www.biotechinkinsider.com)

Medical Writer Caldwell, Susan, PhD’s Groups:

• American Medical Writers Association (AMWA)
• Drug Information Association (DIA)
• Bay Area Biotechnology Consultants Network (BABCN)

•    MedDevice Engineers
•    Drug Information Association - BioPharmaceutical professionals
•    Medical Device Networkers
•    Pharmaceutical Marketing
•    Lifesciences Opportunities in US
•    LinkEds & writers
•    Pharmaceutical Discussion Group
•    Consultants Network
•    (BIOPHARMER) Biotechnology, Pharmaceutical and Medical Device Recruiters Network
•    Pharmaceutical and Healthcare Professionals Worldwide Network - www.PharmaWorldNet.com
•    BayBiotech Review Networking Group
•    Freelancers & Self-Employed Professionals
•    American Medical Writers Association (AMWA)
•    Informed Ideas For Writers
•    BayBiopharma
•    Biotech & Pharma Professionals Network
•    Medical Marketing & Communications Group
•    Pharma Marketing and Advertising Group (PMAG)
•    The Life Science Executive Exchange
•    Science & Technology Media Professionals™
•    Medical Device Development, Marketing And Sales
•    Biotechnology/Pharmaceuticals
•    BioTech Regulatory & Quality Professionals Network
•    Technical Writer Forum
•    Medical Device Professionals Network
•    Science Writers
•    Oncology
•    Medical Device Opportunity
•    HealthCare & Wellness Innovators, Medical, Pharmaceuticals & Biotech Innovation Health Care Network
•    Authors of Business Literature
•    eCTD Professionals Network
•    Clinical Research Jobs
•    Professional Medical / Scientific Writers
•    MEDICAL AFFAIRS PROFESSIONALS
•    BIOTECH & PHARMA Professional
•    American Independent Writers
•    Clinical Trials in the Rest of the World
•    Medical Writing and Affairs Association
•    The Corporate Blogging Think Tank
•    Christian Writers Guild
•    GAVI
•    SRG Clinical
•    Innovation RainMakers(r)
•    Medical Biotechnology Group
•    Social Entertainment Professionals
•    Linked Local Belmont, CA
•    BABCN
•    Medical Affairs UK

Medical Writer Caldwell, Susan, PhD’s Honors:

• Biographee, Who’s Who Registry of Outstanding Professionals (2006-07)
• Biographee, Who's Who in the World (2002)
• Biographee, Who's Who in the World (1997-98)
• Biographee, Who's Who in Medicine and Healthcare (1997-98)
• Biographee, Who's Who in Medicine (1996)
• Biographee, Who's Who Worldwide Registry, Platinum Edition (1992-93)
• Biographee, Who's Who in Science and Engineering (1992-93)
• Biographee, Who's Who of American Women (1989-1993)
• Outstanding Performance Achievement Award (Genelabs Inc., 1989)

Medical Writer Caldwell, Susan, PhD’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch