Jennifer Morris

Section Editor - Regulatory Matters

Jennifer’s professional career spans more than 25 years, the majority of which have been devoted to the pharmaceutical industry. She has worked for companies both large and small, ranging from medical communication agencies to large pharma corporations, and in digital, online, and print media. She has been a member of AMWA for over a decade, EMWA since 2018, and the Board of Editors in the Life Sciences since 2002. Her LinkedIn profile can be found here.

jennifer.morris@merck.com

Contributions

Regulatory Matters - Volume 30, Issue 4

One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…

Regulatory Matters - Volume 30, Issue 3

Early in my regulatory medical writing career, I wrote several protocols in the cardiology therapeutic area. I was introduced to the cardiac biomarkers troponin I and N-terminal prohormone brain natriuretic peptide (NTproBNP), which are indicators…

Regulatory Matters - Volume 30, Issue 2

The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…

Regulatory Matters - Volume 30, Issue 1

Calling all medical writers: Focus your writing with lean authoring In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data.…

Regulatory Matters - Volume 29, Issue 4

Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…

Regulatory Matters - Volume 29, Issue 3

Background for immunooncology studies - Accumulated research of more than a century has led to our current  expansive understanding of the vertebrate immune system as a complex, multi-functional, evolutionary unit: a diverse, powerful, and adaptable…

Regulatory Matters - Volume 29, Issue 2

Master trial documents for increased efficiency and scientific integrity.

Regulatory Matters - Volume 29, Issue 1

A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation

Regulatory Matters - Volume 28, Issue 4

Using technology to reduce the time it takes to generate patient narratives

Regulatory Matters - Volume 28, Issue 3

Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…

Regulatory Matters - Volume 28, Issue 2

Vignettes - Life After Medical Writing - Volume 28, Issue 1

Regulatory Matters - Volume 28, Issue 1

November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…

Regulatory Matters & Regulatory Public Disclosure - Volume 27, Issue 4

A symbiotic relationship is an “intimate interaction between two or more species, which may or may not be beneficial to either”.1We can think of the bee and flower relationship. The flower provides the bee with nectar, while the bee provides…

Regulatory Matters - Volume 27, Issue 3

Nearly everyone remembers the childhood tale of The Wizard of Oz. Four characters searched for something they believed magic alone could create, only to find that they already possessed it. The image of the Tin Man comes to mind, who believed he did…