Writing for a pharmaceutical sponsor or a CRO

Pharmaceutical sponsors and contract research organisations (CROs) offer medical-writing roles with different responsibilities, working pressures and development opportunities. The choice affects how much of a project the writer coordinates, the skills used day to day and the directions a career can take.

Division of work

Pharmaceutical companies develop product pipelines as research and financial sponsors and purchase technical services. ¹ Their writers support regulatory submissions and scientific publications, working with physicians, researchers, statisticians and other medical professionals from start to finish. ¹ As well as drafting, they monitor project progress and writing quality and act as coordinators, process controllers and decision makers on writing matters. ¹

CRO writers concentrate on drafting documents, coordinating review cycles and working with sponsor contacts to finalise and archive them. ¹ The division of an outsourced project generally follows this sequence: ¹

1. The sponsor screens, evaluates and selects service providers, with resource allocations settled in a formal contract.
2. A kick-off meeting establishes procedures, timelines, stakeholders and the division of responsibilities before work begins.
3. Off-site writers draft documents, coordinate reviews, consolidate comments and update or finalise the text; sponsor project managers or writers coordinate external investigators' and internal teams' comments.
4. The sponsor electronically archives all drafts and final documents with traceable version numbers and dates.

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Skills and commercial priorities

Sponsor writers are expected to understand compound strategies, regulatory affairs or publications, time and project management and budget planning. ² CRO writers may need greater attention to detail and a higher level of writing skill, alongside the ability to handle several writing tasks quickly, learn new subjects independently and produce sufficiently good documents under demanding client pressure. ² Emotional intelligence, positive sponsor relationships and negotiation of timelines and prices also matter. ²

Commercial priorities differ: sponsors seek cost-effective providers of high-quality writing, while CROs aim to maximise revenue when negotiating fees. ^{1, 2}

Career directions

Within a pharmaceutical company, a junior writer can progress to technical expert or lead, performance manager or director, or move into another function such as project management or regulatory affairs. ^{1, 2} CROs offer similar writing career paths, with a better chance of moving into business development or consulting where the writer's abilities suit those roles. ²

Starting on either side

Working pace and client variety can change markedly between employers. ³ In a 2019 account from China, a writer moved from pharmaceutical companies to a CRO after nine years and found the first six months frustrating despite substantial experience, because the pace was faster, business perspectives differed and client preferences varied. ³ She did not necessarily recommend a CRO as a first writing job: rapid changes of project and client might leave too little time to develop writing skills or deep knowledge of compounds and diseases. ³ Her advice to writers who do begin there was to review progress regularly to avoid burnout before becoming well-rounded professionals. ³

Sponsor roles can expose a beginner to the wider research and development process, including publication planning, marketing and regulatory colleagues, product launches, indication applications, post-market reimbursement and compound-development projects with service providers. ³ New sponsor-side writers should give equal attention to increasing knowledge and developing writing skills; versatility matters when the role spans those activities. ³