David Stacy

Knowledgeable about the critical elements for success in pre-clinical and clinical research, medical writing, drug discovery, toxicology, PK/PD/ADME, drug safety, and global regulations.

Senior Medical Writer at Jiangsu Hengrui Pharmaceuticals (2025-01 – Present)

• CSR, protocols

Senior Medical Writer at LumiThera (2024-01 – 2024-12)

• CER

Contract Medical Writer at Adicet Therapeutics (2023-01 – 2023-12)

• IBs

Senior Medical Writer at Ono Pharma (2022-01 – 2022-12)

• Protocols, IBs

Senior Medical Writer at Medtronic, Philips, KPS, R&Q (2018-01 – 2018-12)

• Sections of CER, CEP
• Heart valves, drug-coated balloons, peripheral stents, MRI System

Senior Medical Writer at NAMSA, Black Diamond (Ethicon) (2017-01 – 2017-12)

• CER, 3 manuscripts

Senior Medical Writer at E-team, NAMSA (2016-01 – 2016-12)

• CER, biological safety

Senior Medical Writer at Covance, Novella (2015-01 – 2015-12)

• Protocols, CER

Senior Medical Writer at Aerotek, Radiant Systems (Kimberly Clark) (2014-01 – 2014-12)

• CSR sections, 510(k)s

Senior Medical Writer at Radiant Systems, Trinity (2013-01 – 2013-12)

• Class I & II devices

Principal Medical Writer at ICON (2021-01 – 2021-12)

• CSR, protocols

Senior Medical Writer at Cardinal Healthcare (2020-01 – 2020-12)

• Non-clinical documents (pharmacology, toxicology, PK/PD)
• CSR

Senior Medical Writer at Cumberland Pharmaceuticals (2020-01 – 2020-12)

• Protocols, amendments

Senior Medical Writer at Premier Research (2019-01 – 2019-12)

• IB, informed consent

Senior Medical Writer at Self-Employed (1999-06 – 2023-01)

US and foreign drug and device companies

• Advisory Committee meetings and FDA meeting preparation
• Submission of regulatory documents, regulatory affairs consulting
• Evaluate therapeutic areas of interest, in-license drugs for development, especially in cardiology, diabetes, oncology (medical, immunology, gynecologic, pediatric, hematology, radiation, surgical), ophthalmology, orthopedics (spine, knee, pins, screws, plates, wires, & rods), obesity, infectious disease, plasma products, CNS disease & nephrology
• Publications, communications, reports, manuscripts, abstracts, slide sets and protocols
• Regulatory writer: INDs, NDAs, BLAs, ANDAs, ISS, ISE, CSRs, IMPDs, CERs, 510(k)s, PMAs, IDEs, amendments and supplements, investigator brochures, templates, subject information, informed consent forms, subject narratives, create and maintain templates, clinical study reports, and clinical evaluation reports
• Editing, proofreading, and reformatting document text before the final QC
• Strategic planning and project manager for devices and drug-device combinations
• Manage editors and junior medical writers
• Clinical and non-clinical data analysis
• Manage personnel in contract labs and pharmaceutical companies

Manager, Medical Writing at QST Consultations Ltd (2010-12 – 2011-09)

Regulatory submissions for pharmaceutical and device companies

• Regulatory writer: INDs, NDAs, BLAs, ANDAs, ISS, ISE, CSRs, IMPDs, amendments and supplements, investigator brochures, templates, subject information, and informed consent forms, create and maintain templates, clinical study reports, internal publications, protocols, and SOPs
• Reviewed and edited documents for consistency, clarity, compliance, and scientific terminology
• Managed two editors and a contract medical writer
• Dermatology: Psoriasis, wound healing, infectious diseases, dermatitis, anti-fungal, incontinence, cosmetics (Botox®)
• Developed/refined strategic CMC regulatory plans for global development programs

Associate Professor of Physiology at St Eustatius School of Medicine, University of Medicine and Health Sciences, International American University, and Caribbean Medical University (2009-02 – 2012-11)

• Taught physiology, pharmacology, neuroscience, and biostatistics to medical students
• Created PowerPoint lectures and course material
• The preparation, administration, and grading of examinations
• Developed new instructional materials and teaching techniques with participation in on-going reviews and revision of curriculum planning
• Curricula and admissions committees

Senior Medical Writer at Kos Life Sciences (2005-02 – 2005-08)

• Wrote study protocols, abstracts, manuscripts, posters, medical education material, investigator brochures, clinical study final reports, data summaries
• US and international regulatory submissions (INDs, NDAs, IMPDs, amendments, supplements)
• Project management skills
• Ability to interpret and present data accurately and concisely
• Worked with editors, drug information and other medical writers
• Ensured documents are of high quality in terms of scientific content, organization, accuracy, format, clarity, and consistency

Senior Medical Writer at Speedel Pharma (1998-12 – 2008-11)

• Regulatory writer: INDs, NDAs, ANDAs, ISS, ISE, MAAs, CSRs, amendments and supplements, pharmacology and toxicology study reports, SOPs, investigator brochures, annual reports, manuscripts, abstracts, slide sets, subject information and informed consent forms, subject narratives, summaries of safety and efficacy
• Strategic planning, "go / no-go" decisions for drugs to treat pulmonary hypertension and resistant hypertension (endothelin antagonist, renin inhibitors)
• Business development, licensing

Contract Medical Writer at Otsuka America Pharmaceuticals (1998-12 – 1999-06)

• Wrote abstracts, manuscripts, protocols, SOPs, study reports, regulatory documents

Senior Scientist IV at Otsuka America Pharmaceuticals (1996-05 – 1998-12)

• Pharmacology: developed two novel rodent models of aspirin-insensitive arterial thrombosis: tested anti-thrombin, anti-Xa, and anti-VIIa compounds for thrombosis
• Developed rat models of intermittent claudication; Tested catheters to deliver drugs and growth factors locally, measured blood flow (microspheres, Transonic flow sensors), and vasculogenesis (latex and plastic polymers)
• Tested drugs to treat heart failure and vascular disease (all work was done under GLP regulations)
• Investigated new indications for drugs already approved and worked closely with clinical research and marketing to enhance product marketability
• PK/PD/TK studies and analysis for efficacious and safe drugs

PhD in Cardiovascular Physiology – University of Nebraska Medical Center

Exercise Physiology – University of Iowa Medical Center

BA in Biology – Oral Roberts University

Physics, Aerospace Engineering – University of Kansas