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Medical Writer Susan E Caldwell, PhD, 23 Feb 2015 Page 1 of 5
Susan E. Caldwell, PhD
2043 81
ST
Ave SE
Mercer Island, WA 98040
Tel: 206-949-1121
Fax: 650-332-2752
Email: caldw[email protected]
Summary
Work Experience: Deep background in regulatory medical writing and biotechnology product
development, and a strong publication record in the peer-reviewed medical literature—an unusual
combination of medical writing expertise, analytical skills, management experience, and medical
knowledge. Experienced in all phases of drug, biologic, and medical device product development, with
emphasis on clinical development. Manage medical writing groups, mentor and develop junior writers,
and build medical writing infrastructure.
Writing Experience: Write, edit, and review ICH-compliant US and international regulatory submissions
(numerous INDs, NDAs, sNDAs, BLAs, sBLAs, 6 eCTDs, 2 combination drug/device submissions, and
1 CTA); clinical study protocols and amendments; clinical study reports (CSRs); serious adverse event
(SAE) and adverse event (AE) narratives; briefing packages; investigator brochures (IBs); process
development and manufacturing/CMC documentation; manuscripts, slides, brochures, and white papers;
SOPs and templates; internal reports; and web site content.
Clinical writing experience includes oncology; pediatric and adult neurology; infectious diseases;
immunology, allergy, and inflammation; cardiovascular disease; ophthalmology; drug, biologic,
and medical device manufacturing (CMC); and more.
Example indications include acute myeloid leukemia (AML), age-related macular degeneration
(AMD), analgesia, anemia, atherosclerosis, chronic granulomatous disease (CGD), chronic
kidney disease (CKD), congestive heart failure (CHF), coronary artery disease (CAD), Crohn
disease, glioblastoma multiforme (GBM), graft-versus-host disease (GVHD), hepatitis B (HBV)
and C virus (HCV) infections, HIV/AIDS, infant epilepsy, influenza virus infection, multiple
sclerosis (MS), multiple myeloma, myelofibrosis (MF) and myeloproliferative diseases (MPDs),
non-Hodgkin lymphoma (NHL), non-small-cell lung cancer (NSCLC), pancreatic cancer,
phenylketonuria (PKU), polycythemia vera (PV), renal failure, squamous cell carcinoma (SCC),
and others. Experienced with light-activated drugs and other combination drug-device products.
Headed medical writing groups at 4 biotechnology companies and 1 clinical research organization
(CRO). Strong experience developing quality review processes for clinical and regulatory
documents. Very comfortable with staffing, training, mentoring, and managing medical writing
departments. Extensive medical writing project management experience.
Broad drug, biologic, and medical device product development experience, from discovery and
preclinical through clinical research, postmarketing, process development, and
manufacturing/CMC.
Major Accomplishments: Two major submissions that were approved by FDA: (1) Led medical writing
team in developing an NDA/eCTD submission for Kyprolis™, approved in July 2012; (2) was lead writer
on the team at Berlex Laboratories that prepared an sBLA for Betaseron®, approved by the FDA.
Academic Background and Early Work Experience: PhD in medical microbiology and immunology;
postdoctoral laboratory experience in human infectious diseases at Wake Forest School of Medicine,
Winston-Salem, NC. Early work experience as laboratory scientist at Genelabs Inc. (Redwood City, CA;
acquired by Glaxo in 2008) and Baxter Healthcare (Dade Diagnostics Division; Miami, FL).
Publications and Presentations: Publications in peer-reviewed journal articles, book chapters, news-
letters, and web content. Strong publication record in the peer-reviewed journals and presentations at
medical conferences (see Scholarly Publications). Published the Biotech Ink Insider newsletter for
medical writers. Author and publish a medical writing blog, Biotech Ink Spots.