Program Tracks

The Professional Science Master's in Scientific Writing program at Temple University offers students the choice between two educational tracks that provide them with skills specific to the environments they wish to seek employment in after graduation. Below is a breif overview of each of those tracks and a list of the courses available to students in each respective track.

Marketing/Regulatory Writing

The Marketing/Regulatory Writing track offers students the opportunity to take courses that will provide them with the knowledge and skills necessary to work in environments such as a pharamceutical company, a patent law office, or a regulatory agency.

  • QARA 5502: Regulation of Medical Devices: Submissions

    This course provides an overview of medical device submissions. The course begins with a review of laws specific to medical devices such as the requirement for pre-market submissions. Specific topics include device classification, investigational device exemption (IDE) applications, pre-market notification submissions [510(k)s], pre-market approval applications (PMAs), humanitarian device exemptions (HDEs), product development protocols (PDPs), STED and an overview of Global Harmonization Task Force recommendations.

  • QARA 5592: Food and Drug Law

    This course studies the governance of intra- and interstate commerce in foods, drugs, cosmetics, and medical devices and the effects of the Federal Food, Drug and Cosmetic Act upon research, manufacture, marketing, and distribution of drugs.

  • QARA 5533: Requirements for Product Labeling and Advertising

    Prerequisite: Food and Drug Law (5592) or permission of the instructor

    This course examines strategies for creating drug labeling during new product development, for updating existing product labeling, and for creating “harmonized” core data sheets for products marketed globally. Students gain insight and awareness of current trends in advertising and promotional regulation.

  • QARA 5534: Regulatory Aspects of Biomedical/Technical Communication

    This course reviews regulatory requirements of biomedical/technical writing in the pharmaceutical industry. Students research, summarize, and organize typical scientific data. Issues of content (relevancy, accuracy, balance, and currency), organization, and style (e.g., American medical Association Manual of Style and current FDA and ICH guidelines) are addressed. Writing exercises include topics such as the Physician's Desk Reference, developing product label package inserts, and summarizing studies in pharmacokinetics, pharmacodynamics, efficacy and safety, product development, and stability.

  • QARA 5545: Post Approval Changes

    This course reviews PAC guidelines developed by CDER to maintain product safety, efficacy, and quality while giving manufacturers substantial regulatory relief and flexibility. A basic review of formulation development of various dosage forms provides a complete understanding of the guidelines and of regulatory strategies for formulation development.

  • QARA 5548: Risk Management of Pharmaceutical and Medical Devices

    This survey course focuses on risk management requirements and practices in the pharmaceutical, medical device, and biotech industries. Current regulations and risk management tools will be discussed and utilized to provide students with experience in executing risk assessments.

  • QARA 5611: Advanced Topics: Regulation of Advertising and Promotions

    This course reviews the regulatory and legal fundamentals of advertising FDA-regulated products, including prescription pharmaceuticals, OTCs, and biologicals. Discussions will include how these regulations differ from those applicable to restricted medical devices and food products.

  • QARA 5594: Regulation of Dietary Supplements, Botanicals, and Nutraceuticals

    The course focuses on legal issues surrounding the regulation of dietary supplements, nutraceuticals, and botanicals. When does a dietary supplement become a drug under the Federal Food, Drug and Cosmetic Act? What are the legal requirements for labeling? How are claims treated? These topics, along with current issues related to the regulations of dietary supplement are explored. The impact of the Dietary Supplement Health and Education Act, the Federal Food, Drug and Cosmetic Act, the FDA Modernization Act (FDAMA), and other relevant laws are examined. The enforcement authority of other federal regulatory agencies, that is, the FDA and the Federal Trade Commission, is detailed.

  • QARA 5596: Food Labeling and Regulatory Affairs

    This course provides students with an in-depth understanding about how food in the U.S. must be labeled regardless of its country of origin. It examines the roles and procedures of the principal regulators (U.S. FDA and the USDA) and their interaction with the regulated industry and third party peripherals, including consultants and analyzing laboratories. Students will learn about the food label and all of its components, problems associated with incorrect or deceptive labeling, including the risks to consumers and food manufacturers, marketers and sellers. The course introduces regulatory intelligence identifiers, including the generation of press releases and notifications when recalls are warranted. Finally the impact of recent or impending legislation or regulations for food businesses regulated by FDA (especially the Food Safety and Modernization Act) will be discussed. Students will learn to identify the critical components of a food product’s label, gain knowledge of the laws and regulations governing food labeling, and understand the intricacies of recalls and market withdrawals.

Popular Scientific Writing

The Popular Scientific Writing track will provide students with the opportunity to gain the skills and and knowledge necessary for careers in fields such as mass market journalism, publishing, and other mass media environments.

  • JRN 5012: Reporting and Writing II
    • Credits: 4

    Accelerated, in-depth instruction in various forms of writing, nature of news, structuring news stories, style, information gathering, copy editing fundamentals, with emphasis on multimedia reporting.

  • JRN 5003: Editing the News I
    • Credits: 3

    Accelerated, in-depth, instruction in editing; editorial judgment; accuracy; headline writing; fundamentals of page makeup; use of illustrations, with emphasis on story and photo editing, print design, style and usage.

  • JRN 5013: Editing the News II
    • Credits: 3

    Accelerated, in-depth, instruction in editing; editorial judgment; accuracy; headline writing; fundamentals of page makeup; use of illustrations, with emphasis on story and photo editing, print design, style and usage.

  • JRN 5151: Literary Writing in Journalism
    • Credits: 3

    This graduate-level course will examine the 50-year trend, begun by the New Journalism of the 1960s, which uses the storytelling techniques of fiction and the documentation of journalism to create works of powerfully-told emotional truth.

  • JRN 5005: Communication Law
    • Credits: 3

    Legal and philosophical study of government regulation of information transmission from 15th century to the present. Emphasis on legal descriptive research methods.

  • JRN 5212: The Entrepreneurial Journalist
    • Credits: 3

    New opportunities exist for aggressive journalists. In this course, we'll discuss the various ways to be a content generator - from freelancing to blogging, from starting magazines and newspapers to creating multimedia web sites.

  • MSP 8741: Cybermedia Workshop
    • Credits: 3

    Hands-on development of content using new media forms. Students are involved in the design, scripting, and production of one or more programs. Projects may include interactive programs, "edutainment" games, multimedia presentations, and other digital content for distribution to business, schools, or consumers.

  • ENG 9400: Seminar in Rhetoric and Composition
    • Credits: 3

    Intensive reading and study of rhetorical and/or composition in a small class setting. Content varies. Can be taken more than once for credit.