Faustina Sackey, PhD

(**** Staffordshire Lane, Charlotte, NC 28213. TEL: 919-***-****. Email: addic8@r.postjobfree.com)

Medical Communications Specialist

Summary:

I work as a freelance medical writer, editor, and reviewer, collaborating with professionals and Contract Research Organizations (CROs) to provide services to a network of pharmaceutical companies, medical device companies, biotechnology firms, academic institutions, and independent clients. I support the design of protocols, data analyses, statistical inference, and interpretation of outcomes. I communicate research strategies and engage in cross-functional and global collaborations to integrate medical, scientific, and commercial research input. I am involved in publication planning, develop medical peer-reviewed publications, educational, and regulatory materials with a high level of quality regarding content organization, clarity, accuracy, formatting, and consistency. I write and coordinate preclinical study reports (PSR), clinical study reports (CSRs) clinical evaluation reports (CERs), and patient narratives for US, Asia, and European submissions as well as annual INDs, NDAs, and IBs reports. I perform SEO searches for social media blogs creation and marketing, using appropriate keywords for higher rank search engines. I conduct all levels of editing, fact-checking, proofreading, and review of medical, pharmaceutical, healthcare, and life science documents.

I am currently looking for a remote opportunity in the fields of medical communications.

Education:

Advanced Certificate in Medical Writing, Medical Writing Institute, Haddonfield, NJ, March 2017

Postdoctoral Training, Medical College of Wisconsin, Milwaukee, WI, Feb 1995-Feb 1996

PhD in Biochemistry, Loeb Research Institute, University of Ottawa (uOttawa), Ontario, Canada, Nov 1991-Dec 1995

MS in Pharmaceutical and Medicinal Chemistry, Loughborough University of Technology (LUT), Leicestershire, UK, Aug 1985-June 1987

BS in Biological Chemistry, University of North London (UNL), UK, Aug 1982-June 1985

Writing/ Editing Experience:

East Carolina University, Greenville, NC Aug 2018 – April 2019

Freelance Contract Medical Writer/Editing Manager for medical device projects

• Led, managed, and contributed to regulatory and publication medical device writing projects:

Clinical project involved focal point alignment of LINAC by isocentric design to deliver high resolution, optimally planned conformal radiation for each position of the radiation gantry and stage rotation. Contributed to planning, writing, and editing of CER, including a summary of safety, clinical performance, risk management assessments, and MDD-MDR.

• Preclinical project involved the design and development of new low-intensity magnetic stimulator (LI-MS) to evoke motor cortical excitability for the restoration of circadian rhythm in mice circadian defective model–Contributed to reports involving data analyses and synthesis in the evaluation of the correlation between neural function and stimulation response, efficacy, safety, adverse effects, and neural predictors of clinical outcomes.

Umm al-Qura University Health Science Center, Mekkah, Saudi Arabia Oct 2018 – Present

Freelance Contract Principal Medical Writer/Editor

Lead and manage medical publication writing projects, rewrite, edit, proofread, and check facts. Documents preparation for manuscript submission, developmental editorial role, make use of various CMS for submissions.

CACTUS Global, High Impact Medical Communications Aug 2017 – Present

Remote Contract Medical Editor/Reviewer, Script Writer, Storyboarding, PowerPoints

• Manage medical publication projects: Review, edit, proofread and check facts. Involved in infographics for videos

Sanko University, Faculty of Surgery and Medicine, Turkey Feb 2017 – Present

Lead and manage medical publication writing projects, rewrite, edit, proofread, and check facts. Documents preparation for manuscript submission. Make use of various CMS for submissions

Lumina Datamatics. http://luminadatamatics.com/publishing. Nov 2017 – Present

https://luminadatamatics.com/publishing/

Freelance Contract Senior Editor, Manuscript Development, Editorial and Enhancement for Publication

Editor, proofreader, facts checker, rewriter, and reviewer of life science, health, and nutrition manuscripts for publication. GPP, ICMJE guidelines, quality control, final formatting and graphical outputs, rapid responses to client inquiries, post-release edits.

Mouxz Translators, China, 译通天下. Sep 2016 – Dec 2018

Freelance Contract Senior Rewriter/Editor

Editor and rewriter of medical, pharmaceutical, and life science research manuscripts.

North Carolina Central University, Durham, NC May 2016 – Aug 2016

Contract Grant Writer at Biomanufacturing Research Institute and Technology Enterprise (BRITE)

Recruited as a skilled grant writer to assist the institution in writing the following grants for funding by the NIH, NSF, and Thurgood Marshall Foundation:

Transforming Undergraduate STEM Education (Thurgood Marshall Foundation)

The award, PI: Dr. Kaye Thompson-Rogers, Director, Health Careers Center, North Carolina

Determination of Clinical Correlation between Total and Active PCSK9, and PCSK9 regulators A1AT

Award PI: Dr. Dayami Lopez, Associate Professor, BRITE Institute, NCCU

Induction of Oxidative Stress in Mice Models and Validation of NGF Potentiation Abilities of Phenoxy

Thiophene in Neurorestoration. Award PI: Dr. Gordon Ibeanu, Assistant Director, BRITE Institute, NCCU.

Duckweed Feeds the Needy. PI: Dr. Debra Parker, Dean, School of Behavioral and Social Sciences NCCU, and Taylor Fish Farms

MOGOEdit, Xian, China, http://en.mogoedit.com/) Jul 2015 – Dec 2018

Contract Medical Science Manuscript Rewriter/ Editor

Rewriting and editing medical, pharmaceutical, and life science research manuscripts.

FAS International, Charlotte, NC Jun 2006 – Present

Freelance Medical Writer/Rewriter/Editor/Reviewer of owned company

Writing, revising, editing, and proofreading scientific, pharmaceutical, and medical research articles, blogs for subject matter experts, including Life Science Publishing, Measurement, Inc., different writing websites (Upwork, Outsource, Freelancer, and individual clients' request). Protocols for in-vitro diagnostic (IVD) products such as reagents, test kits, and blood glucose meters, assay protocols, and data analysis. Developing and synthesizing data summaries, tables, digests, present, and analyze data. Employing good writing skills—Organization, extensive and proper literature research, making appropriate notes and outlines, review, proofread, and finalize

Life Science Publishing, O'Fallon, IL Jun 2006 – Aug 2014

Freelance Contract Writer/Editor/Reviewer

Writing, revising, editing, and proofreading, medical, pharmaceutical, and life science articles.

Regulatory documentation prepared were as follows: Clinical study protocols, including research aims, goals, hypothesis, significance, background describing drug characteristics, dosage, efficacy, toxicity assessment, study design, double-blinded, placebo, exclusion/inclusion criteria to determine eligibility, ICF, baseline measurements

Clinical study reports (CSRs) to summarize the outcome of clinical trial studies

Clinical evaluation plans, reports, safety, and clinical performance, risk management assessments, post-market surveillance, post-market clinical follow up, Medical Device Directive, and Regulations (MDD-MDR), including, Europe, China, and Japan

CFDA Medical Device Clinical Evaluation Technical Standards: Clinical literature, clinical trials, sufficient technical and clinical information, sample size, indication, coverage, Asian/Chinese data subgroup, adverse event reporting, auditing summary, compliance with technical guidelines and industry standards

Narratives: Documentation on the medical history of patients and the likelihood of SAEs

Investigator Brochures (IB) on dosage, dose frequency/intervals, and methods of administration, safety monitoring procedures, briefings on non-clinical studies, title page and confidentiality statement

NDA: Prepared meeting briefing materials, including agenda, PowerPoint presentation slides, a waiver for the conflict of interest and proposed upcoming meeting dates

Labeling: Prepared labeling documentation under 5 subheadings, including box warning, indication, and usage, dosage administration, contraindications, and precautions

Research and Development, Measurement Inc., Durham, NC Nov 2006 – Aug 2013

Remote Contract Content Writer

Science and Math Item Writer (AP Biology, Hon Biology, Chemistry, Biochemistry, and Math)

Duke University Medical Center, Durham, NC Aug 2000 – Mar 2005

Research Scientist/Medical Writer

Heart developmental research, using DiGeorge syndrome model of neural crest ablation to study aberrant sonic hedgehog signaling (Shh)

Research in kidney failures, mice models to study the biochemical and molecular basis of immune regulation leading to self-tolerance in systemic lupus erythematosus (SLE)

Manuscript writing/editing, preparation of PowerPoint presentations, grant writing

Orentreich Foundation for the Advancement of Science (OFAS) Jun 1997 – Aug 2000

Researcher/ Writer

Phase III Endocrinology: Type 2 Diabetes. Participants: 45. Drugs under study: Combined Pioglitazone and Metformin trial to improve insulin sensitivity

Participation in the monitoring of Phase III diabetes clinical studies

Preparation of regulatory documents which includes, screening procedures for research eligibility, pre-enrollment documents for Type 2 diabetes, CSRs, ICFs for determination of eligibility, materials, and methods proposed to use for recruitment, wash-out (drug withdrawal) procedures to prepare for actual studies. Documents submission to IRB. Materials preparation for INDs submissions to IRB, NDAs, IBs

RECENT MANUSCRIPTS, ARTICLES, AND BLOGS (Ghostwriter/Editor/Reviewer)

Surgery and Healthcare Articles

Mortality risk factors in war-related pediatric burns: A comparative study among two distinct populations. Published March 16, 2018. https://www.sciencedirect.com/science/article/pii/S0305417918301025 (Sanko University writing contract, Sevgi Buyukbese Sarsu, Aydin Budeyri

Hair-tourniquet syndrome: A new microsurgical perspective for the treatment of two delayed cases and a literature review. 9/28/17. (Sanko University, Aydin Budeyri & colleagues)

Convertible implants: Combined custom deltoid lateralization implants and adjustable humeral reverse shoulder prosthetics for the repair of failed total shoulder arthroplasty. 4/15/17. (Sanko University, Aydin Budeyri). Published in Seminars in Arthroplasty. 2017:28(3):140-144.

Glenohumeral osteoarthritis in young patients: Stemless total shoulder arthroplasty trumps resurfacing arthroplasty–Affirms. 4/7/2017. (Sanko University, Aydin Budeyri and Co.). Published in Seminars in Arthroplasty. 2017;28(3):113-120.

Z-plasty technique to manage complications resulting from gastrocnemius flap surgery of total knee arthroplasty. 3/10/2017. (Sanko University, Aydin Budeyri and Co.)

Thenar Compartment Syndrome: What If a compartment pressure measuring device is absent? 12/31/2016. (Sanko University, Aydin Budeyri and Co.). Published in Cureus on February 16, 2018.

https://www.cureus.com/articles/10723-thenar-compartment-syndrome-what-if-a-compartment-pressure-measuring-device-is-absent

Calcific tendinitis of the iliotibial band. Submitted 12/09/17. (Sanko University, Aydin Budeyri and Co). Published Medicina Dello Sport. 2017;70(2):227-31.

Comparison between treatment outcomes of coronary artery bypass graft surgery performed in public and the private sector in the USA. 4/07/2016. (Upwork writing contract, C. Hidalgo).

Mediport central venous catheter (CVC), a totally implantable, tunneled venous-access port, inserted by making a small incision on the right of the neck carotid artery for patients with stage IVA of squamous cell carcinoma of head and neck to undergo regional Cisplatin, Adriamycin, Mitomycin cycles of antineoplastic combined chemotherapy. CERs on examination of benefits and risk factors for CVC catheter, including systemic complications of poor catheter performance, thrombosis, and infections. 2/8/15. (Life Science Publishing).

Medical Ethics Articles

Ethical challenges in blood and marrow transplantation (Series in preparation)

Ethical challenges in the work of not-for-profit medical organizations (Series in preparation)

Ethical challenges in epidemic breaks. (Series in preparation)

Other Medical and Pharmaceutical Related Articles

The study of serum and urinary NGAL and Cystatin C levels as biomarker tools for diagnosis of both AKI and CKD: A histobiochemical comparative study. Sinna MM, Altaf FMN, Mosa OF. Published in Current Pharmaceutical Design. 2019;25:1.

Surveillance of one-year pulmonary tuberculosis cases at Al Taif province using different diagnostic tools. Umm Al-Qura University. Dablool AS. Published in Life Science Journal 2019;16(3).

Preclinical studies on the use of magnetic stimulation to treat abnormalities in circadian rhythm to normalcy for disease states such as insomnia, sleep apnea, neurological diseases (Parkinson's, Alzheimer's), mental disorders (manic depression, bipolar). 9/6/2018 (Ongoing Upwork writing contract).

Semantic recognition of stimuli for depressive and emotional syndromes. 4/13/18

(Premium Editing. Mouxz Translation and Editing, China).

Clinical manifestations and prognostic characteristics of SCZ, BPD, and MDD. 4/15/18

Premium Editing. Mouxz Translation and Editing, China).

Frailty and cognitive impairment in predicting mortality among oldest-old people. 4/12/18

(Premium Editing. Mouxz Translation and Editing, China)

Terminalia chebula (TC) Retz, a popular traditional India and East Asia medicine with a potential of curing ischemic stroke. 11/27/2017 (Rewrite. MOGOEdit, China)

A high-throughput screen of a compound library for the identification of novel small molecule inhibitors of C. elegans caspase CED-3. 4/9/2017. (NCCU Project)

Osteoactivin participates in the development and progression of periodontal disease 3/25/17. (Editing MOGOEdit)

Protective effect of vitamin C on hydrogen peroxide-induced eryptosis in the Dai Chinese population with glucose-6-phosphate dehydrogenase deficiency. 12/27/2016. (Rewrite, MOGOEdit)

Association between serum zinc levels and the risk of Parkinson's disease: A meta-analysis. 12/19/2016. (Rewrite, MOGOEdit)

Variations in 2 and 4 digit ratio in males and females and correlation to their reaction times. 11/28/2016 (Freelancer writing contract Carlita90)

The impact of uric acid changes on kidney function in perimenopause and postmenopausal women with normal renal function-a retrospective cohort study. 11/15/2016. (Rewrite, MOGOEdit)

Effects of ASA IV and inhibitors on osteoblasts proliferation and differentiation. 9/20/2016. (Freelancer Client, Rewrite contract, Lee Yang)

Spider bites, symptoms, causes, and treatment. 9/14/2016 (Upwork writing contract, source solutions, Ltd)

What you need to know about fibromyalgia. 9/6/2016 (Upwork writing contract, Source Solutions, Ltd)

Synthetic Biology: Prospects in ten years. 05/12/2016. (Upwork writing contract, J. Edwards)

Regulation of the HDV cDNA endogenous promoter activity by hepatitis delta antigens. 5/6/2014. (Life Science Publishing)

Percutaneous Cryoablation for Liver Cancer, using the RYO care System and Cryohit systems. Li-Zhi Niu and Co, China, 3/12/2014.

Effect of rat brain tissue extracts on osteoblast growth and differentiation. 4/30/2014. (Life Science Publishing)

Mesh nebulizer and pharmaceutical drug developments, using steroid aerosol therapy. Pritchard JN and Co. 2/12/2014 (Life Science Publishing)

OMRON 4 sphygmomanometer automatic BP measurement device evaluation using the British Hypertension Society grading system. Belghazi J. 6/12/2007. ( Life Science Publishing).

Skills

Proficient in the English language

Excellent communication skills

Clarity

Attention to details

Competent in computer and software usage

Substantial knowledge of varied therapeutic areas

Regulatory/scientific guidelines

Data integrity

Literature search

Project management skills

Leadership qualities

Relationship-building

Dependability

Critical thinking

Adaptable

Efficiency

Confidence

Collaboration

Conscientiousness

Microsoft Word

Microsoft Excel

PowerPoint

Adobe Photoshop

Microsoft Word editing tools

Adobe Acrobat pdf copyediting tools

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