Showing an employer your writing
Writing samples demonstrate a writer's skills and experience. A useful portfolio makes suitable work easy to find, explains the writer's contribution and respects confidentiality and ownership.
Suitable samples
Samples can come from outside medical writing, and should show that a complex subject can be described clearly and concisely; work that has undergone peer review carries additional weight. One writer won a first medical-device writing job over seven other applicants without prior experience, on the strength of samples including a fictional piece that moved the laboratory director. The portfolio included a draft manuscript, thesis excerpts, graduate-course essays, a campus-newspaper article and award-winning fiction.
Unpaid client projects can become a portfolio: one writer's graduate-school work included grant proposals, book-chapter editing and website design. A short review of 500–1,000 words on a relevant, current topic can also demonstrate research and writing ability, even without peer review.
New writers with little previous work can publish LinkedIn articles on a topic or in an approach suited to their intended niche or job, inviting professional feedback and discussion. An employer may explicitly request a sample: the ASRT required a CV and writing sample from prospective freelance contributors in a 2006 panel account published in 2007.
The context in which each sample was created should be disclosed so that an interviewer can assess it appropriately. A text box can identify the writer's responsibilities, such as researcher, writer, editor or proofreader.
Permission and confidentiality
Confidentiality is the biggest obstacle to maintaining a healthy portfolio from job to job. Published manuscripts, patient-information brochures and press releases containing a trial-efficacy summary can provide samples; even a confidential document may contain a suitable extract, such as a therapeutic-area literature review. Such extracts should be cleared with the legal or regulatory affairs department, preferably before the writer leaves the position.
Where a client owns copyright, permission can be sought from the client or through a rights-clearance service. Writers should understand the applicable copyright provisions and the AMWA Code of Ethics when deciding what is appropriate for each sample. Some writers create unpaid, unsolicited samples to avoid copyright issues and supply work they would otherwise lack.
Practices described in 2011 included shortened versions, removal of drug or device names, reduced and overlapping screenshots showing a project's breadth without readable words, and display of only the contents or abstract. Advice on redacted samples differs: a 2007 recommendation was not to submit confidential or proprietary work even with sensitive portions blacked out, but to create a nonconfidential sample demonstrating writing ability.
Electronic presentation and retrieval
A writing portfolio should be electronic and demonstrate the skills and experience needed for a job. It allows rapid responses to opportunities and convenient exchange when writer and client are in different places or using different devices, while demonstrating technical competence.
PDF combines text, graphics and fonts in one self-contained file; Microsoft Office and OpenOffice can save documents in this format. Web samples should be converted to PDF rather than relying on a page that a later website update may remove; paper samples can be scanned to PDF and the paper recycled. Presentation advice includes eye-catching colours and borders, highlighting a byline with colour or a box, and drawing attention to the journal name with arrows or underlining.
Storage and delivery options described in 2011 included local files sent by email, compressed folders when attachment limits apply, public or client-provided FTP sites, and remote website or online storage from which a link could be sent instead of the document. Free transfer sites could have size limits and paid upgrades; online sample storage also provided a backup.
There is no single correct filing scheme, but samples need to be found quickly, including during a telephone interview while the prospective client waits for an emailed example. Drug or disease names can appear in filenames, with similar samples grouped into logical folders such as therapeutic areas or disease states. A portfolio website needs a hierarchy that allows immediate retrieval and clear navigation for clients browsing independently.
At an in-person interview, a laptop can show samples from the portfolio website or a complete local copy of the site on portable media; this demonstrates technical competence and avoids leaving potentially proprietary paper samples behind.
Alternatives for confidential regulatory work
Almost all clinical-research and regulatory-writing projects are confidential, a constraint familiar to those hiring in these fields. Clinical study reports written for an employer cannot simply become freelance samples or be placed on the writer's website. An experienced clinical or regulatory writer may be able to establish in a fifteen-minute telephone interview whether a candidate has actually written investigator's brochures, clinical study reports, integrated safety and efficacy summaries or briefing documents.
Seven alternatives proposed in 2013 were:
- Give the prospective client a former client's name and telephone number to discuss the quality of the work, after obtaining permission.
- Make a previously written clinical study report generic by removing identifying names and data. This takes many hours but can show organisation, critical thinking, writing and editing; reports still differ despite ICH E3.
- Create an original, generic ICH-compatible template that can be shared as a sample and used for a small company without one.
- Prepare outlines of integrated safety or efficacy summaries previously written, with drug and sponsor identification removed, to demonstrate knowledge of their contents.
- For a drug marketed for years with little remaining confidential material, seek permission to distribute part of a previously written investigator's brochure; otherwise remove identifying information from a previous brochure and use it or an extract.
- Write and publish, on a website or elsewhere, an article or standard operating procedure about writing a clinical study report or integrated safety summary.
- Provide one of these alternatives together with another type of work, preferably related to clinical research, such as a publication manuscript.
Any of these was proposed as sufficient to replace an actual regulatory-document sample. A contrasting ethical scenario asks whether an employer requesting a regulatory sample would be more impressed by a recommendation letter than a redacted clinical study report, recognising the difficulty of anonymisation and the candidate's respect for confidentiality; it does not resolve the choice.
References can demonstrate ability without disclosing confidential work. A writer can explain the ethical obligation, promise the same protection for the prospective client's information, acknowledge the difficulty this creates in assessing the work, and offer clients who can independently describe their experience of similar projects. This provides a way to verify ability through personal recommendation and acknowledges the value of existing clients' opinions. Referees should be asked in advance every time and told who may contact them.
One writer declines samples altogether and uses project lists and references instead. One writer who supplied a complete document early in her career never heard from the prospective client again and suspected it had been taken as a template; in her experience, knowledgeable clients generally did not request samples. In one writer's experience, sample requests more often came from people seeking a model for producing a document themselves than from people assessing writing ability.