There will be a $60 fee upon acceptance into the program
Using an anatomy and physiology systems approach, this course reviews common terms associated with medical practice, research, and different healthcare settings. The goal: to better prepare individuals to be productive in healthcare work environments. Students should be able to decipher an entry in a medical chart or record and know how to approach and read unfamiliar terms. Students complete the course within the 4 week section in which they are enrolled.
This course presents the statistics essentials for the non-statistician involved in clinical trials. Topics include study designs, hypothesis testing, sample size calculations, assumptions, controls, endpoints, data management principles, data presentations and analysis plans, methods for analysis, and conclusions.
In this course you will take a diagnostic test to determine basic strengths and weaknesses in your knowledge of grammar and usage. You will complete 10-20 exercises online each week which are electronically scored to give you immediate feedback. Also, you will complete several challenging assessments. Topics covered include parts of speech, clauses, phrases, verb tenses, punctuation, and mechanics. The instructor will provide structured lessons and feedback, but you will have the option to spend more time on topics you need to review and less on those already mastered.
Copyediting I, II, III and Grammar Lab are offered every quarter. Please check the Enrollment Available Online date on the Extension Calendar to find out the next date that classes will publish to the web.
All 14 units required
This course introduces the basics of writing and editing scientific and medical materials, and provides an overview of the careers available in Medical Writing. Topics include:
This course builds on the knowledge gained in Medical Writing and Editing I and introduces the student to some of the more complex topics in writing and editing scientific and medical materials. Topics include: choosing the best format for the topic, research report, clinical study report, grant proposal, review article, book chapter, poster, slide presentation or other; conceptualizing the topic, organizing the material, composing, drafting and revision; version control; manuscript preparation and submission; the editing of numbers, numerals, and units of measurement including SI units; tables and figures, and P values; drugs and equipment; organisms and pathogens; and nomenclature used in oncology, cardiology, and pulmonology. In addition to completing AMA-supplied homework on these topics, students will visit corresponding websites each week to complement their knowledge.
This course focuses on how to construct effective, accurate and attractive figures, tables and graphs. Course content includes basic statistics, principals of the visual display of quantitative information, critique of selected medical graphics, and exercises to develop graphics which present values clearly, label them appropriately, and provide sufficient context for readers, for a variety of formats.
This course covers the basic principles of medical ethics (autonomy, beneficence and justice) as they apply to the delivery of healthcare and to human subjects research, from a medical writing perspective. Ethical reasoning skills are developed using real life case studies through analysis of actual cases.
8 units required
No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the FDA. Good documentation for clinical trials must be clear and scientifically sound, and it must conform to instructions. In this course, participants will discuss and practice the basic principles of clear medical writing and study the rules governing effective clinical trial documentation. Prerequisites: Medical Terminology, Drug Development Process, and GCP courses, or proven mastery of content.
The most vital tool available for assuring product quality, integrity, and consistency is good documentation practices. This highly interactive course covers fundamental principles and techniques required to write cGMP procedures. Students can bring samples of their own documentation to be audited during the course. Students will learn techniques to write and improve cGMP documentation to ensure compliance with regulatory documentation.
Guiding a new product through the stages of research, development, clinical trials and submission of an IND and New Product Marketing Application requires the input of nearly every area within a pharmaceutical company. This course presents a road map for taking the product from bench-scale operations in the research laboratory to full-scale manufacturing production and the requirements for GMP product approval. Pitfalls will be discussed and consideration will be given to the regulatory and quality requirements at each step.
This keystone course examines the drug development process and history of clinical trials. Topics include sources of new drugs & devices; the process of discovery; how a discovery becomes a drug or device; the definition, phases, and purposes of both pharmacological and clinical development; the history of drug/device regulation and effects of historical events on regulatory oversight; investigative new drug applications; and premarket approval applications.
Concepts of cancer treatment and management will be communicated to the student through a series of web-based sessions, with a sharp focus on the terminology, pathology, diagnostics, disease management. Intended for individuals with educational backgrounds in biological sciences at the associates, bachelor or masters level. Nurses, research assistants, data managers and others who are involved in oncology research or would like to become involved in this area of research and development would benefit from this course.
Included: an overview of cancer biology, diagnosis and specific types of cancer, as well as basic principles, treatment modalities and potential effect of those treatment modalities.
This course reviews the breadth of U.S. and international regulations associated with the development of drugs, biologics, medical devices, and diagnostics. Topics include a review of regulatory agencies and the role/responsibilities of each; pathways for regulatory applications; important differences between development processes in the U.S. and those of other countries; and the impact of regulatory approval processes on corporate strategy.
This advanced-level course reviews the science that forms the basis for effective clinical trial design. Topics include classifying and describing trial design by stage in drug/device development; types of trial designs; defining the hypothesis and study objectives; safety information and DSMBs; determining the population and sample size; study procedures; identifying and selecting clinically meaningful endpoints; scientific/ethical considerations; and statistical validity of design, execution, analysis, and reporting.
Required Capstone Project
In this course, students apply all previously learned concepts to produce a capstone project. This will demonstrate an understanding of the publishing process, including ethics and fair use copyright, and the usefulness of “Instructions for Authors.” Students will learn how to use primary and secondary trial registries (such as “clinicaltrials.gov”, and others) and how to locate sources of guidelines for publishing various kinds of trials, such as CONSORT and EQUATOR Network. The “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” from the International Committee of Medical Journal Editors will be required reading as will CONSORT documents. Students will locate a clinical trial in JAMA or any Archives journal. They will then find the clinical record for the trial, list publications that have come about because of the trial, and present a review of it covering all aspects of the IMRAD format. They will review the publication for consistency with the CONSORT statement and the ICMJE “Recommendations”. They will prepare and present a PowerPoint project from the above materials. Students will also edit a short prose piece and take a quiz on publishing terms.
Medical writers play a vital role in creating continuing medical education (CME) materials that help physicians and other health care providers remain current in the knowledge and skills needed to provide high-quality care. Students will add to what they learned in Introduction to Medical Writing about learning objectives, needs assessments, and adult learning principles and will write a complete CME activity that includes these elements. Students will learn how to select the best resources for developing a CME activity, how to choose the most appropriate format for an activity, how to select the proper scope of content, and how to write questions based on evidence and best practices. Various types of CME activities will be addressed, including print, live (slide-based), and self-study. Students will also learn about evaluation tools to establish whether educational needs and objectives have been met and whether participants' knowledge, competence, or performance has improved.
Regulatory Writing is as much about knowing the regulations and guidance that govern regulatory submissions as it is about the building the intelligence, knowledge, relationships, and know-how in becoming an effective partner at the table. This course is designed to help you
· Gain a better knowledge of the regulations and guidance documents that govern certain regulatory documents and processes in the US and EU.
· Gain hands on experience in thinking through and writing the CSR, a key regulatory document, and
· Understand your role, responsibilities, critical behaviors, and practical work practices that makes you a better Regulatory Writer
Competition for funding for scientific projects is becoming increasingly difficult. Further, many researchers and scientists lack the ability to package their projects in a way that is clear and compelling. Many universities, hospitals and research institutes have therefore hired medical writers and editors to assist their staff in grant proposals. Medical grant writers and editors are an emerging job market with competitive salaries and multiple job venues. This course will develop students’ grantsmanship skillsets and provide tools that will enable to talk and edit "fluently" in three languages (DOD, NIH, Private). Students will learn how to take an idea all the way to a funded grant, learning all the steps along the way and producing sample templates they can reference. They will be able to find and understand grant solicitations, plan and lead grant proposal teams, understand how different agencies and foundations evaluate and fund, and adopt tactics for professional success.
In this Capstone course, students will apply all previously learned concepts to work through one or more projects in one of the four pre-identified Medical Writing areas (Scientific Grants, Continuing Medical Education, Publication, or Regulatory). The purpose of the capstone course is to:
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Candidates are encouraged to apply in the certificate program as early as possible to take advantage of program benefits.
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Successful applicants must have relevant educational background, and native-level fluency in English with the demonstrated ability to write clear, logical, and grammatically correct sentences as evidenced by the application, official transcripts and writing samples. Accepted applicants will have degrees in biomedical or life sciences, such as biology, chemistry, pharmacy, nursing, nutrition, or public health. It is anticipated that many will have advanced degrees, including PhDs. Candidates with PhDs are particularly competitive for medical writing positions in the commercial sector and academic settings.
Upon acceptance into the Medical Writing Certificate Program, you must complete the prerequisite courses listed below before enrolling in the first course Introduction to Medical Writing. If you would like to request a waiver of completion for these prerequisite courses, please send your transcripts, CV, and/or resume to Stephanie King at firstname.lastname@example.org be considered.
Non-Native English speakers must provide proof of English language competency via either a score of 90 on the iBT (TOEFL) test or a 7.5 on the IELTS test.
Riverside University Health System
Massachusetts General Hospital/Harvard University
PhD, MPH, MBA
Panorama MedWriters Group, Inc.
APR, Fellow PRSA
UC San Diego School of Medicine
UC San Diego School of Medicine, Moores Cancer Center
Rosenberg Business Communications
MS, MBA, CMPP
UC San Diego
There will be a $60 fee upon
acceptance into the program
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