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"Alle Ding sind Gift und nichts ohn Gift; allein die Dosis macht, das ein Ding kein Gift ist." (Paracelsus, 1493-1541) All things are poison and nothing is without poison, only the dose makes a thing be poison.
Pharmacometrics Medical Writing
In a nutshell, I’m a freelance medical writer who actually specialises in pharmacometrics! By that I mean know about ADME and NONMEM, know the difference between popPK, PBPK, and PKPD, won’t freak out when I see a 2-compartmental model or a set of differential equations with parameters denoting Cmax or Hill coefficients and understand how these all combine in model informed drug development, from toxicology to phase 4 clinical trials.
Between publications work, which is my main focus, I’ll also take on regulatory submissions of things like modelling reports (which otherwise take an age to go through), as well as promotional projects and copywriting tasks. My job is to allow scientists to actually do science, convince stakeholders and decision makers to invest time and resources, and keep projects moving from beginning to end!
What I do...
Regulatory Checks
Compliance & Documentation
This is the bridge between data and approval, ensuring documents meet ICH, GCP, company SOP standards etc.
You need to be able to take on a clinical study report, an investigator brochure or a summary for CTD modules, and match that against the relevant regulatory framework.
Needless to say this requires and eagle eye for detail, because where there are irregularities there are delays, and delays cost time, money, and, potentially, life saving treatments reaching their patients.
Publications (Primary Focus)
Between Data & Knowledge
I sign the relevant non-disclosure contracts, then take what you already have (modelling reports, clinical trial data, symposium presentations) compile it, process it, then turn that into a scientific paper.
I’ll also take an existing draft and develop that and tailor that into a format your target journal will accept.
I handle the administrative paperwork and liaising with the journal throughout the submission phase, and can be on hand when it comes back months later following peer review, to help get it over the finish line and into print.
Healthcare Copywriting
Promotional Med Comms
Where an awful lot of marketing is ‘move fast and break things’, promotional medical writers must ‘move just as fast whilst staying compliant and scientifically authoritative’.
Just because it’s a cosmeceutical product line for a US D2C audience doesn’t mean you get to ignore the FDA, and if you’re trying to convince the NHS to invest in drug candidates then God help you if you don’t understand how the MHRA or ABPI code works.
Fortunately I do, having a background in both D2C and B2B marketing for a diverse range healthcare and other clients.
Where do you need me?
One of the joys of freelance medical writing is that all I really need is a laptop and an internet connection. My clients can be anywhere in the world, so provided we have legal contracts & business insurance in place, I can generally help you. I have worked with clients in the US, UK, Switzerland, France, Japan & beyond!
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Don't let your data sit there!
My job is not letting good science go to waste! The world needs to know!
