October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing may seem very different from academia, but you are more equipped for this transition than you may realize! (No, I’m not referring to your pipettes…) Today, graduate students have access to several resources to help them break into the field of medical writing. While I encourage you to check these out, I also want to point out that you’r ..read more

December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist  │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases, INDs, preparation for pre-IND meetings, and the submission and maintenance of INDs.  But in October 2018, the FDA released new draft guidance outlining best practices for early drug development and pre-IND meetings for rare diseases.  Given the near-perfect cross-over potential, we thought this was a sign th ..read more

May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical writing, QC refers to the process of ensuring the quality and accuracy of a final medical writing deliverable. In this post, I hope to answer many of the questions that our clients often ask us, such as: Why QC? What does QC entail? When should it occur? Who should QC? Why QC? The “why” of QC is straightforward – our goal is to deliver ..read more

August 25, 2016 | Kim Nice, PhD, Associate Director, Medical Writing and Submissions Management | Medical Writing Services In previous posts, you were introduced to the role of regulatory medical writing and heard about the day-to-day activities of a regulatory medical writer. In this post, I will tell you about the skills you need to be good at the job. In my role at IMPACT, I spend a good deal of my time mentoring our staff on regulatory medical writing. I am often asked “What makes a good regulatory medical writer?” My initial reaction was to say “being a good scientist”, but when I gave ..read more

August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but quickly learned that it’s is an exciting mix of summarizing data, educating your clients/teams on regulatory considerations, and becoming a bit of a social dynamic expert. In thinking about the best way to tell you what regulatory medical writers do each day, I thought that walking you through the potential career progression of ..read more

February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services You’re finally there! You and your colleagues find yourself at the doorstep of being able to submit either a New Drug Application (NDA) or Biologic License Application (BLA) for a compound that your team has been dedicated to for years. The hard work of bringing a new compound to market – and to the patients who need it – is about to pay off. It’s time to begin planning for your submission. “Submission planning” – what does this encompass exactly? And when and how do you go about doing it ..read more

June 2, 2020 | Kathryn Tworkoski, PhD, RAC  |  Principal Clinical Research Scientist  |  Regulatory Affairs, Medical Writing, Drug Development Consulting In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of INDs.  In these earlier posts, we mentioned […] The post KEEP ‘EM COMING: AN OVERVIEW OF IND UPDATES appeared first on IMPACT Pharmaceutical Services, Inc ..read more

October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing – congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing may seem very different from academia, but you are more equipped for […] The post From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing appeared first on IMPACT Pharmaceutical Services, Inc ..read more

August 30, 2019 | Nicole Tackmann, PhD, Clinical Research Scientist II | Medical Writing Services The process of moving from the world of academia into the world of regulatory medical writing was an exciting and scary time for me. Luckily, I found a great place to make the transition, and I started my medical writing […] The post Eight Things About Regulatory Medical Writing That May Surprise an Academic appeared first on IMPACT Pharmaceutical Services, Inc ..read more