![]() Although a large part of the job is quietly working on your own, you need to be able to work with cross-functional teams, usually in many time zones. Snagging of formatting and transcription checking of data. Several rounds of review and comment adjudication. There also an element of project management - data coming from different teams at different times. You’ll be given all the data from the study, and sub reports from statistical analysis teams and others, and other documents from the project which will give you most of the background, so you’re not starting from scratch. ![]() ![]() As a writer, you should be involved with the study team while the trial is still ongoing and the data is being gathered and interpreted so you get a feel for it and know what the messaging/positioning is. There is a template that everyone uses - google ICH E3.( /sites/default/files/E3_Guideline.pdf ). If you want an example then I can tell you about clinical study reports. It’s also perfect for those times in your career you want flexibility and the ability to work remotely. But if you are a medical writer you will be able to do regulatory writing. I’ve only done regulatory writing myself so can’t comment on whether the timelines and pressures are any different between the two. Instead of your peers and people holding the purse strings, it’s persuading government agencies about safety and efficacy of your medicine in people.ĭay to day the writing job is the same, once you get your head around the document aims and templates. The science is the same, but the intended readers and outcomes are different. Writers tend to work for pharmaceutical companies or CROs running the trials and/or providing writing services to various companies. This involves documents such as clinical study protocols and then the study report on completion. As opposed to documents for academic publishing and conferences. Regulatory writing in this context involves documents intended to be submitted to regulatory authorities (eg MHRA, FDA, EMA) to support license applications for clinical trials and/or medicine approvals. Thanks so much for replying! How would you recommend I investigate opportunities in this field? Is there anywhere specific these jobs are advertised the way academic jobs are? With no experience in this area, would I just make contact with a company in response to an advertisement or is there some sort of preparation I should do first? I don't have any idea of the different types of jobs in this field, are there any websites that give an overview of the different opportunities? In your current job, what audience are you typically writing for? I've written many scientific papers and also in my last job did a bit on trying to simplify research goals/achievements for a lay audience to justify charity support but I can't visualise what a typical project as a medical writer might be? For me, salary is less important at this stage of my life as my mortgage will soon be paid off and children independent so happy to take a pay cut to ditch my commute and restore my work life balance!
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