Open seminar: in cooperation with Klinkner und Partner, we offer a negotiation seminar in Munich (December 11-12th 2018), which will be tailored to an audience from QM/auditing.
Documentation and regulation
The term kafkaesque describes situations in which a helpless subject has to navigate an endless bureaucratic machinery, without ever getting to a meaningful outcome. What would the writer say to the group of jobs in this section? Would he be shocked that despite all the computers in use nowadays, we´re still printing out mountains of paper, file them, watch them get dusty and finally bin them? That we multiply the fire load in the company building with yet another mountain of documents, Health and safety, all signed in triplicates by every Tom, Dick and Harry? Or would he be amazed that all the complex procedures, which are happening in today´s enterprises, are documented and regulated in such a pragmatic and focused manner? Let´s first of all take a closer look at the individual groups of jobs.
As depicted in the SOP (Standard operating procedure) “17_04_14_Description of occupational groups”, we´ll first deal with the quality manager (QM). Once you have read this section, it officially counts as training of this SOP. Please sign this certificate, so that I can enter this training procedure into our overview matrix.
Do we exaggerate, even make fun, or is this the reality in a typical industrial context?
Let´s do a fact check. In order to get certifications (e. g. GxP or ISO), certain guidelines have to be followed. These primarily deal with whether or not the documentation and processes are traceable and well-structured. These are pretty formal, bureaucratic guidelines. However, when taking a closer look, one realises that they are formulated in a rather general sense. It is therefore necessary to adjust the rules to the reality in your company and exactly that´s the skilful part of the job. How can you achieve this, without keeping your colleagues from their “actual” work? Is it sufficient to scan barcodes and let the database do the documentation work or are signed paper documents needed? Can the trustworthiness of a supplier be determined from your desk or do you have to visit them for an audit? And can you use the audit to address other important points like business development en passant? And maybe the most important question, “How do I get my colleagues to use my documentation infrastructure, to “live” it?”
In Health and safety, balance is the key word as well. Do you really have to use the handrails everywhere, even if it´s only a couple of steps? Does a “zero accident policy” make sense or is it a misguided incentive to conceal minor accidents? Is a worker effectively protected by a face mask or does this make accidents more likely by blocking part of her visual field? And even in an office: from when on is a mess getting literally dangerous, namely in providing a stumbling block? When working in Health and safety, you should not only provide clean documentation, but also bring along an understanding of practical issues.
All pharmaceuticals, but also many chemicals, need to pass regulatory procedures before reaching the market. Which requirements do the individual phases of clinical trials have to fulfil? Is a chemically synthesised biomolecule a small molecule drug or a biopharmaceutical? What is REACH and why does this have to be done for many (new) chemicals nowadays? And once the materials safety data sheets and package inserts have been finalised, you´ll need to check whether the marketing department has limited its praise to within the legal limits in their brochures. For a position within the field of regulatory affairs, you should bring along a keen understanding of technical and legal issues and enjoy moving within the triangle of (clinical) studies, documentation and regulations. One such position is the medical writer, who is responsible for the documentation of clinical or epidemiological studies. These are essentially the regulatory reports for the approval authorities. The tasks can even be broadened to include the evaluation of data and parts of the study organisation as well as writing operator manuals and applications.
What triggers a person to enter such fields? The idealised motivation to decide for a certain job field is an ardent intrinsic interest for the content and inner meaning of the work. This does not seem reasonable to you for such types of work? Well, there are lots of fields which are quite an acquainted taste. Just remember the blank stares of the people when you tried to talk about your research at a party for the last time. Most likely you could literally read on their faces, “Good that someone does this, whatever it is supposed to be, but better even that it´s not me! Next topic please.” So, please don´t judge too quickly about job sectors which appear somewhat dry at first.
If we could not trigger profound fascination for clean documentation with this document, we may at least mention some practical advantages of these types of jobs. In the fields of QM and Health and safety, there are various positions you can enter when coming straight out of university. Many tasks can be done in a flexible work arrangement, e. g. in home office. And as small and medium-sized companies usually do not have dedicated departments for these tasks, you can also offer your expertise as a freelancer. In regulatory affairs departments, the requirement for prior work experience is typically higher, but this field offers a variety of avenues to and from other jobs within clinical trials.
Dry paperwork or an exciting field at the interface between law and science? This you need to decide for yourself before making a decision. And if you decide for it, you´ll have the delicate task to find the balance between strict rules and the requirements of a lively work environment every day.