Senior Medical Writer at Jiangsu Hengrui Pharmaceuticals (2025-01 – Present)
Senior Medical Writer at LumiThera (2024-01 – 2024-12)
Contract Medical Writer at Adicet Therapeutics (2023-01 – 2023-12)
Senior Medical Writer at Ono Pharma (2022-01 – 2022-12)
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)
Senior Medical Writer at E-team, NAMSA (2016-01 – 2016-12)
Senior Medical Writer at Covance, Novella (2015-01 – 2015-12)
Senior Medical Writer at Aerotek, Radiant Systems (Kimberly Clark) (2014-01 – 2014-12)
Senior Medical Writer at Radiant Systems, Trinity (2013-01 – 2013-12)
Principal Medical Writer at ICON (2021-01 – 2021-12)
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)
Senior Medical Writer at Premier Research (2019-01 – 2019-12)
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
