Medical Writer Senior

CURRICULUM VITAE

David Lowell Stacy

***** * **** *******

Lenexa, KS 66227 USA

Mobile 913-***-****

*******@*****.***

EDUCATION

•University of Nebraska Medical Center, PhD, Cardiovascular Physiology

•University of Iowa Medical Center, Exercise physiology (transferred to UNMC)

•Oral Roberts University, BA Biology

•University of Kansas, Physics, Aerospace Engineering (transferred to Oral Roberts)

SUMMARY OF QUALIFICATIONS

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.

Medical Writer / Regulatory Affairs

•Regulatory writer: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, ISS, ISE, MAAs, CE Mark, CMDA, CSRs, CERs, CEPs, 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

•Common Technical Document (CTD) module writing, preparation and update including:

•Module 2.4 (Pre-clinical overview)

•Module 2.5 (Clinical overview)

•Module 2.6 (Pre-clinical summaries)

•Module 2.7 (Clinical summary)

•Module 4 (Nonclinical study)

•Module 5 (Clinical reports)

•Compliance to MDEV 2.7/1 Rev 4 / MDD to EU Medical Devices Regulation 2017/745 (MDR) / ISO 13485

•Help lead the effort to create global strategies for worldwide medical device and drug approvals to introduce new products to market

•Post-Market Surveillance Report (PMSR) / Pharmacovigilance - Periodic Safety Update Report (PSUR), Post-Market Surveillance Plans (PMS), Post-Market Clinical Follow-Up Plans (PMCF), Summary of Safety and Clinical Performance (SSCPs), Development Safety Update Report (DSUR)

•Develop and review manuscripts, abstracts, posters, monographs, white papers, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, interpretation, and alliance with business objectives

•Reviews statistical analysis plans and TFL specifications for content and for grammar, formatting, and accuracy

•Knowledge of FDA/CBER/CDRH/EMEA/GCP/GLP/ICH/CMC guidelines for drugs, devices and biologics, experience communicating and meeting with FDA

•Knowledge of PubMed, Medline, Cochrane, and Embase databases

•Managed editors and medical writers (contract and in-house)

•Contributed to regulatory strategies for US and global products and ensured clients are in full FDA compliance

•Participated on relevant project teams and task forces, and provided guidance to clinical, safety, and pre-clinical research

•Review and edit documents for consistency, clarity, compliance and scientific terminology

•Developed timelines for completion of clinical components

•Familiarity with clinical study reports & raw data tables

•Understanding of industry best practices & editorial style guides, including the AMA Manual of Style and the AMCP format for formulary submissions

•Knowledge of US and global drug and device regulations

•Proficient with MS Office 2016

Clinical Project Management

•Project planning and organization (Gantt Charts, MS Project)

•Monitor study progress such as patient recruitment and protocol compliance

•Lead overall activities and optimize the performance of the study team

•Study data listings and tables review, including scientific content and data validation

•Track and manage studies to agreed timeline, budget and resource, highlighting significant variances to the EML and study team

•Train internal and external study personnel in study specific procedures

•Develop detailed study outlines and ensure medical and scientific input in study reports

•Forecast timelines, budget, materials and resource for a defined component of the CDP

Professional Experience

Self Employed, 06/99-09/22, Lenexa, KS/Grand Rapids, Michigan/Raleigh, NC/Coral Springs, FL

Senior Medical Writer, 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 and informed consent forms, subject narratives, create and maintain templates, clinical study reports, and clinical evaluation reports

•Editing, proofreading and reformatting document text prior to 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

Some of the clients included:

2022

Adicet Therapeutics

Contract Medical Writer

•IBs

2022

Ono Pharma

Senior Medical Writer

•Protocols, IBs

2018

Medtronic, Philips, KPS, R&Q

Senior Medical Writer

•Sections of CER, CEP

2017

NAMSA, Black Diamond

Senior Medical Writer

•CER, 3 manuscripts

2016

E-team, NAMSA

Senior Medical Writer

•CER

2015

Covance, Novella

Senior Medical Writer

•Protocols, CER

2014

Aerotek, Radiant Systems

Senior Medical Writer

•CSR sections

2013

Radiant Systems, Trinity

Senior Medical Writer

•510(k)s

Permanent Positions:

2021

ICON

Principal Medical Writer

•CSR, protocols

2020

Cardinal Healthcare

Senior Medical Writer

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

•CSR

2020

Cumberland Pharmaceuticals

Senior Medical Writer

•Protocols, amendments

2019

Premier Research

Senior Medical Writer

•IB, informed consent

QST Consultations Ltd, 12/10-09/11, Allendale MI

Manager, Medical Writing

•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

St Eustatius School of Medicine, University of Medicine and Health Sciences, International American University, and Caribbean Medical University: 02/09-11/12; Goldenrock, Basseterre, Vieux Fort, Willemstad (St Eustatius, St Kitts, St Lucia, and Curacao)

Associate Professor of Physiology

•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

Kos Life Sciences, 02/05-08/05, Westin, FL

Senior Medical Writer

•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

Speedel Pharma, 12/98-11/08, Basel, Switzerland

Senior Medical Writer

•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

Otsuka America Pharmaceuticals, 05/96-06/99, Rockville, MD

Contract Medical Writer, 12/98-06/99

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

Senior Scientist IV, 05/96-12/98

•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

•Brought the animal facility into USDA compliance and helped in the planning and design of the new facility

•Head of the IACUC committee for 1 year: hired animal technicians, and a veterinarian consultant

•Managed the animal facility and learned the guidelines for animal husbandry and facility regulations

Texas Biotechnology Corporation, 09/92-02/96, Houston, TX

Clinical Project Manager

•Ensured FDA/GCP/ICH guidelines are followed

•Monitored and reported adverse events, review CRFs

•Prepared INDs, NDAs, amendments, supplements, manuscripts, abstracts,

study reports

•Coordinated project implementation and management

•Initiated sites for clinical trials, evaluated site suitability

•Prepared and followed project budgets and timelines, monitor progress

•Conducted project meetings and reported progress to senior management

•Data manager – entered data into database

•Managed four CRAs (Pharmaco/PPD)

Pharmacologist

•Drug discovery: Tested drugs to treat restenosis, heart and renal failure, stroke

•Tested various means of drug delivery (transdermal, liposomes, depot injection)

•Worked with catheter companies to improve drug delivery (microporous and electrophoresis)

•Tested stents (drug eluting, biodegradable) in peripheral arteries (with the Bioengineering Department of Rice University)

•Licensed-in endothelin antagonist: Determined which therapeutic areas to screen drugs and developed animal models of acute renal failure, stroke, hypertension, and heart failure

Glaxo Inc., 05/88-08/92, Research Triangle Park, North Carolina,

Research Scientist, Department of Pharmacology

•Basic research of the microvascular complications of diabetes and tested

drugs to reduce insulin resistance (joint venture with The Amylin Corp.)

•Monitored renal function in diabetic rats (immunoassay for urine protein)

•Tested vasoactive drugs on the microcirculation (muscle, brain, connective

tissue, kidney)

•Drug discovery of compounds to treat hypertension and heart failure

•Tested phosphodiesterase inhibitors and compounds which elevate cGMP

•Evaluated drugs to both inhibit (tumors) and stimulate angiogenesis (ischemia)

COMPUTER SKILLS

I am proficient with the following software programs: MS Office (2016), Endnote, DistillerSR, Adobe Acrobat and Illustrator, SigmaPlot, and SigmaScan. I am familiar with the PubMed/Medline, Ovid Medline, Embase, Google Scholar and Cochrane databases.

THERAPEUTIC AREA FOCUS:

Cardiology (hypertension, heart failure, MI, stroke, atherosclerosis, thrombosis, drug eluting stents), oncology, infectious disease, nephrology, diabetes, orthopedics, endocrinology, pulmonary, dermatology, ophthalmology, GI, CNS and devices

TEACHING

•2012, Physiology, Neuroscience, Histology and Biostatistics, Caribbean Medical University, Curacao, West Indies

•2011, Physiology, International American University, St Lucia, West Indies

•2010, Physiology, University of Medicine and Health Sciences, St Kitts, West Indies

•2009, Physiology and Pharmacology, St Eustatius School of Medicine, St Eustatius, Netherlands Antilles, Dutch Caribbean

•1988, Renal Physiology, Eastern Virginia Medical School, medical students, Eastern Virginia Medical School, Norfolk, Virginia

•1982, Cardiovascular physiology, University of Nebraska Medical Center, nursing students, Omaha, Nebraska

•1978-80, Exercise physiology, University of Iowa Medical School, graduate students, Iowa City, Iowa

PUBLICATIONS

Eleven articles, 1 book chapter and 22 abstracts published in peer-reviewed journals.

PATENT APPLICATION

1. Denner LA, Dixon RAF, Rege AA, Stacy DL, inventors; Texas Biotechnology Corp., assignee. Antisense molecules directed against a tenascin gene. Publication number W01994021664 A1; Filing date March 24, 1994.

MILITARY

•1987-97, US Army Reserves, medical division (captain)

•1973-74, US Air Force, avionics technician (airman first class)

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