Skills

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, 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 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 blogs creation, 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 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 new medical device projects

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

Clinical Project–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 safety, clinical performance, risk management assessments, and MDD-MDR.

• Preclinical Project–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 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 Medical Principal Writer/Editor

· 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

CACTUS Global, High Impact Medical Communications, Bangalore, India. Aug 2017 – Present

Remote Contract Medical Editor/Reviewer, Video Script Writing, 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 – Nov 2018

Freelance Contract Editor

· Editor, proofreader, facts checker, and rewriter of life science, health, and nutrition manuscripts for publication.

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

Freelance Contract 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 (Edited; in progress)

· 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 (Submitted).

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

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

Contract Rewriter/ Editor

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

FAS International, Charlotte, NC Jun 2006 – Present

Freelance Writer/Rewriter/Editor/Reviewer of a company I founded

· 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).

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)

· 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)

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

Medical College of Wisconsin Feb 1995 – Feb 1996

Postdoctoral Training

Phase I and II Oncology: Leukemia (ALL) in children. Participants: 38. Drugs under study: Combined dexamethasone (Intensol) and vincristine (Oncovin). Duration: 6 months. Preparation: Documents in compliance with ICH safety guidelines. This includes:

· Preparation of ICFs: consisted of 2 parts: a) Information sheet and consent certification and b) Purpose of study, intervention, participant questionnaires, eligibility, procedures, duration of the study, risks, benefits, reimbursement, confidentiality, sharing of results

· Preparation of Pre-IND: Prepared documents consisting of research aims, goals, significance, hypothesis, background, drug characteristics, dosage efficacy, toxicity assessment, study design-double-blinded, placebo, exclusion/inclusion, baseline measurement

· Preparation of clinical study reports (CSRs). Also, medical communications, including posters, PowerPoint presentations, monographs, and brochures

Research Experience:

My bench research career focused on steroid hormone receptors and steroid resistance in cancer chemotherapy, models for studying mechanisms underlying autoimmune kidney failures and developmental heart defects. You will find my significant research contributions through various presentations at scientific conferences and seminars and publications in peer review journals. My clinical research experience focused mainly on regulatory documentation for clinical trials and participation in on-site clinical studies monitoring.

Duke University Medical Center, Durham, NC Oct 2002 – Mar 2005

Research Scientist

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

Duke University Medical Center, Durham, NC Aug 2000 – Oct 2002

Research Scientist

· 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)

Orentreich Foundation for the Advancement of Science (OFAS) Sep 1997 – May 2000

Research Scientist

· Research on cell cycle regulation and the underlying mechanism of alopecia areata. Medication treatments, such as Rogaine to inhibit the process. Preparation of regulatory and clinical documentation: Reports, protocols, and monographs related to type 2 diabetes

Medical College of Wisconsin, Milwaukee, WI Feb 1995 – Feb 1996

Postdoctoral Fellow

· Leukemia and lymphoma bench and clinical research regarding treatment modalities in cancer therapy. Bench work focused on cell cycle regulation and the effects of cancer treatment. Clinical work focused on contribution to Phases I and II clinical studies by preparation of study protocols. On-Site monitoring for Phase I studies

PhD (Loeb Research Institute, Ottawa University, Canada Sep 1991 – Feb 1995

Graduate Student

· Researched on steroid hormone receptors and cancer therapy. The focus was on glucocorticoid receptor variants with aberrant nuclear translocation defect and hence display glucocorticoid resistance in leukemia and lymphoma chemotherapy

Teaching Experience:

My teaching career spanned for over nine years. In 1985, I started teaching medical students biochemistry in medical biochemistry. Topics included inborn errors of metabolism and metabolic disorders, as well as, hormone imbalance and associated diseases, which lasted for five years. I also served as a tutor in loco parentis to an assigned group of medical students during this period. In 1996 I took an appointment as an adjunct assistant professor of biology, teaching, researching, and supervising college students report and dissertation writing.

Mount Saint Mary College, Newburgh, NY Aug 1996 – Jul 2000

Adjunct Assistant Professor of Biology

Medical Biochemistry/Molecular Biology, University of Ghana Medical School Aug 1987 – Aug 1990

Assistant Professor of Medical Biochemistry and Molecular Biology

Honors and Awards:

· Fellow of the medical WritingInstitute (FMWI), The Medical Writing Institute, Haddonfield, NJ Jan 2017-March 2017

· European Economic Community (EEC) Award, UNL, UK June 1983-June 1985

Scholarship granted by the University of North London (UNL) for an outstanding scholar. I received this award at the end of the first year of my undergraduate program, based on my high performance

· Certificate for participation in ROADS program, MCW, Milwaukee, WI June 1996-Sept 1996

I received this certificate by participating in organizing ROADS program, which is an enrichment endeavor to jump-start and expose underrepresented pre-college resident and non-resident students to develop a broad perspective of life science and career options. I set up and introduced science students to various aspects of biomedical research, gathering data, and report writing. I gave seminars on preparation towards college and strategies for students\' retention, graduation to ultimately, promote diversity in the workforce

Professional Affiliations:

· American Association for the Advancement of Science, Since Sept 1996

· American Society for Cell Biology, Since Sept 1990

· British Biochemical Society Since Sept 1985

Voluntary Work:

The Cureus Journal of Medical Science. Jun 2017 – Sep 2017

· Elected as peer-review expert for a breast cancer publication competition on \"Exceptional Responders in Breast Cancer.\" http://www.cureus.com/competitions/TME-exceptionalresponders

The Cureus Journal of Medical Science. https://www.cureus.com/users/32499-faustina-n-a-sackey Mar 2017 – Present

· Reviewing and editing of oncology and other medical science manuscripts for peer-review publication

Resource Volunteer (Duke University Cancer Support Program, Durham, NC Apr 2016 – Jun 2017

· At Duke Cancer Institute, I worked as a resource volunteer, helping patients with literature searches and checking out books that will assist them in understanding their conditions better and how they can maintain good health habits. I also gave them directions to various support groups for further assistance

Durham Rescue Mission, NC, 1201 E Main St Durham, NC 27701 Jan 2014 – Dec 2015

· Participated bi-weekly in mending shattered lives by serving lunch at the food pantry and donating toiletries. The organization caters to the homeless and addicted in the triangle and provides spiritual, emotional, physical, social and vocational education to help them to restore their lives

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

Oncology Articles and blogs

· Combined three-dimensional-printed model and microwave ablation in the treatment of the malignant pelvic tumor. 4/7/18. (Premium Editing. Mouxz Translation and Editing, China)

· Gold-containing compound BDG-I inhibits the growth of A549 lung cancer cells through the deregulation of miRNA expression. 3/19/18. (Upwork Contract. Ali Alhoshani et al. Accepted: Saudi Pharmaceutical Journal, May 21, 2018. Link: https://ac.els-cdn.com/S1319016418301130/1-s2.0-S1319016418301130-main.pdf?_tid=9ec87ef4-e77f-4972-8513-7bf1c7d0cea8

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