Medical affairs writing
Medical affairs is the function inside a pharmaceutical company that sits between its scientific and clinical research and its sales and marketing, and writing for it means producing documents for both sides, each settled by who will read it and what it has to say. Medical communications covers the agency-side field a medical affairs team can commission, moving into medical affairs what working inside the function involves, medical communications and agency roles what moving into agency work involves, and audience and purpose the general principle of writing for a reader that the work applies.
Read the role as a balance that each company strikes differently
The account of the role comes from a former head of medical affairs at a pharmaceutical company, who went freelance in 2015 and published it in June 2016, so it describes the function from inside. The scope of the term "medical affairs" varies between pharmaceutical companies, but the role is a delicate one that balances scientific and clinical research information against communication activities serving sales and marketing needs. From the scientific side it means highlighting the right data in the right context for prescribers to use the product correctly. From the marketing side it means enforcing regulatory requirements that sometimes constrain more attractive wording for advertising. The June 2016 (volume 25, number 2) and December 2019 (volume 28, number 4) issues of EMWA's Medical Writing were admitted from existing Markdown conversions without content repair, and their conversion can break ligatures, mangle multi-column tables, interleave page headers and footers and give figure text as marked text.
Pharmaceutical companies have a responsibility to sell high-quality, effective and safe products for treating illness or relieving pain or symptoms, and they need to communicate accurate information about those products clearly to their customers, practitioners and patients. Medical information also comes from health authorities and the general media, and medical writers are well placed to ensure that this information is communicated appropriately and ethically; the writer has a responsibility to ensure that the right medical information reaches the target reader. Medical writers have a key role in adding value to how the product and the company are perceived. Medical affairs plays a key role in communicating medical information effectively to various target readers while guaranteeing its scientific value, and appropriate, unbiased published scientific and clinical data is a bonus for a company's image. Attribution of industry-financed literature covers what an industry-financed article has to tell its readers about who planned, paid for and wrote it.
It is essential that practitioners have a good knowledge of product characteristics when prescribing new products, but patients also need to be adequately informed about managing side effects to ensure they continue to adhere to the treatment.
Know what the function is and why it has grown
There is no fixed medical affairs structure, function or universal job description. The people in it come from medicine, nursing, science, business, education and marketing, and newer recruits include data scientists, medical writers and translators; many are office-based and some work from home. One group within it works in the field — medical science liaisons, rendered in the article as "medical scientific liaison (MLS)" — who are therapeutic-area experts active across hospitals and primary care and trained to discuss treatment trends and scientific research.
The function exists in every pharmaceutical and device organisation and most established companies have a dedicated team. It began in a supporting role and has become, in many companies, a third strategic pillar alongside research and development and the commercial and market access functions. It works with neighbouring groups such as publications and legal affairs, but the need to avoid conflicts of interest means a clear organisational separation from marketing. Its responsibilities are to understand a constantly changing healthcare environment and provide strategy and leadership across the lifecycle of the company's products; to support innovation, research and data generation; to act as custodian of the information about those products and their use in the relevant therapy areas; and to interact with healthcare professionals, payers, service providers, universities, government departments and, increasingly, patients and patient organisations, giving each of them timely and balanced information. The activities the article's figure assigns to it range from reviewing guideline-mandated regulatory documents and reviewing promotional material for scientific accuracy, through publishing information, working with physicians and peers, liaising with patient groups and education foundations and supporting recognised experts, to the stages of drug development and post-marketing drug safety, including review of individual and aggregate adverse event statistics.
Both interviewees describe the growth from inside. For Orsatti, scientific dialogue has never been so important and medical affairs is no longer seen as a support or approval function but as a strategic and leading one; it can be involved at every phase of development, most intensely in phases II and III, and it owns the scientific strategy — generating unbiased evidence to educate the scientific community, training internal teams, finding the gaps further studies could address, and engaging external experts for insight and feedback. For Doyle the driver in devices was the market. Fifteen years earlier a surgical product could be sold direct to the surgeon without strong evidence of clinical benefit; devices now need economic as well as clinical evidence, buyers want to know how physicians will be trained cost-effectively, and the device regulations have changed the landscape, so physician training and regulatory landscaping made medical affairs matter over the preceding decade. The department Doyle runs has a seat at the table for every development project and writes what it calls a medical affairs strategy for each product, covering the clinical trial, reimbursement, physician training and medical science: whether a trial is needed to register the product or to drive adoption after marketing, what the reimbursement strategy is, how people will be trained, and what the preclinical test plans are.
Expect the document range to follow the company rather than the job title
Depending on the size and structure of the company, essentially any document linked to drug development may fall to medical affairs, from preclinical to post-marketing documents, together with communication brochures and conference or sales materials. The 2016 account sets out examples of documents and their target readers in a table.
| Document | Health authority | Key opinion leader | Scientist | Practitioner | Patients and general public |
|---|---|---|---|---|---|
| Marketing authorisation dossiers, study protocols and reports, oral defence, safety reports | X | ||||
| Summary of product characteristics, package insert or leaflet | X | X | |||
| Specialised or generalised articles | X | X | X | X | |
| Abstract, poster, oral presentation for a congress, conference brochures, information meetings | X | X | X | ||
| Advertising support: sales guides, website, journal, television | X | X | X | X | X |
In a December 2019 account, a writer's part in medical affairs generally depends on the phase of product development and may include study protocols, regulatory documents such as clinical study and clinical evaluation reports, and the full range of publications for professional and lay audiences. How a medical affairs department's own writing team grew is in moving into medical affairs. How a company answers an unsolicited request for off-label information under the US regulator's policy is in medicines information for healthcare professionals.
Know where the reader's information is coming from, not only where yours is
Medical affairs writers create content for a variety of channels, and practitioners increasingly turn first to internet sources and scientific internet databases, such as PubMed or Medline and TOXNET, for a better knowledge of a therapeutic area. Health authority websites carry more specific treatment guidelines and recommendations based on robust meta-analyses of practice in the area; professional societies add detail on current practice drawn from the literature, practitioners' perception of real life, and surveys; patient websites run by clinics or by pharmaceutical companies deliver comprehensive information for patients; and practitioner and patient forums can provide anecdotal information that shows up a misunderstanding, a miscommunication or a lack of medical information.
The writer's own sources are many. Information on efficacy and safety comes from the clinical development programme, such as clinical study reports, publications and other research data, and many studies now also collect data from patients on their view of efficacy or safety, their adherence to the intervention and changes in their quality of life. Quality-of-life questionnaires show how a product affects the patient's daily life, which goes beyond clinical efficacy, and such data are useful for writing patient materials. Specific populations, such as elderly or hypertensive patients, are concerned with efficacy in their own population but are also particularly interested in adverse events and the risk-benefit profile. Other, often forgotten, sources are preclinical studies, post-marketing pharmacovigilance data and sometimes market research data.
Preclinical studies in in vitro or in vivo models can provide evidence about the mechanisms of action behind efficacy or safety, and images from in vitro studies can illustrate a concept: in the 2016 account, a drastic increase in immunofluorescent cell number under an effective drug is more meaningful to people than a schematic graph. Pharmacovigilance can highlight adverse reactions or susceptible subpopulations, often leading to post-marketing surveys. Post-marketing data from practitioners or patients may reveal information about the product that did not surface during clinical development, and post-marketing studies can be useful for evaluating the impact of an identified risk, a new indication or a new technique. Market research data can help position the product within the therapeutic arsenal available to practitioners and patients, and questionnaires on patient satisfaction and on the commercial experience of direct contact with clients are essential for understanding the product's market. Medical affairs writers need interdisciplinary skills to understand these data sources fully and to bring out the key product information, and they have to take the different sources into account and weigh their level of evidence carefully against the key communication messages.
Settle the reader and the key message before anything else
Like any document, a medical affairs document starts from two questions asked before writing. The first is who its final reader is, because the writing style and vocabulary should be adapted to that reader to be meaningful: "headache" is preferred to "cephalgia" for patients or practitioners, whereas "cephalgia" may be preferred in a specialised published article. The second is what key message is to be communicated, since the clearer the message the better readers will understand it. Simple sentence structure is paramount for getting the message across, particularly to readers who are not native speakers of English, and specific medical terms can be replaced with common ones for a given text. Involving the medical affairs writer in developing the key message should be critical, because the writer provides the link between the data and the communication objectives, and the writer adapts the style to convey the scientific content transparently while best presenting the marketing tone and the company image.
In writing for patients, for example, many technical and scientific terms are inappropriate.
The style then follows the document. Regulatory dossiers are written in a simple, direct, informative style, whereas scientific articles tell a story about the research performed. Specific sentences or key words are sometimes recommended: the standard contraindication statement of a summary of product characteristics takes the form "X is contraindicated in children aged x to y", with slots for other relevant subsets such as weight, pubertal age or gender, and a cross-reference to section 4.3. Guidelines for writing the common technical document, such as its safety part, and for clinical evaluation are on the ICH and European Commission websites; journal websites carry instructions for authors; and publication guidelines such as good publication practice, CONSORT, STROBE and the ICMJE recommendations are available. The EASE guidelines give useful tips for non-native speakers of English, and plain-English techniques such as simple sentence structures improve readability. Concise language, a tone adapted to the audience, and clarity in wording and in presentation are the main components of relaying the key message and meeting readers' expectations. Plain language and what clear and precise scientific language is held to carry those techniques, and choosing and using a reporting guideline the reporting standards.