Adapting to an industry that keeps changing
Medical writers face changing regulations, technologies, products, teams and employers. Adapting involves preparing for change, learning new ways of working and maintaining the skills and relationships the work depends on.
Sources of change
Mergers and acquisitions, evolving regulations and innovation make healthcare a volatile, uncertain, complex and ambiguous environment, often described as VUCA. The four aspects can be illustrated in healthcare work as follows.
| Aspect | Illustration |
|---|---|
| Volatility | Constant, rapid change. |
| Uncertainty | Unpredictability. |
| Complexity | Multiple interconnected issues. |
| Ambiguity | Mixed realities, including the convergence of physical and virtual worlds. |
Timelines shift, companies reorganise, products evolve, regulations change and people come and go; writers need to change with their jobs. A writer’s career can involve several kinds of transition: in a 2019 account, one regulatory writer’s more than 13 years of experience included changing countries, moving from employment to freelancing and back, four mergers or acquisitions and six line managers within one company.
An approach to adapting
A practical guide to adapting combines ten recommendations.
- Make working relationships personal, even when contact is virtual; distance need not prevent relationship-building.
- Look forward rather than dwell on the past; challenge claims that the old system was better or that work must always be done the same way.
- Develop a growth mindset that welcomes new regulations, products, approaches and technologies.
- Integrate after a merger: think in terms of a shared team and shared projects while keeping personal principles intact.
- Welcome change, remain agile and recover from setbacks.
- Use technology as an aid, treating life and professional experience as an asset alongside technical fluency.
- Maintain support from family, friends, colleagues and professional communities.
- Take a career break when circumstances call for it.
- Manage with common sense and decency, treating direct reports as the manager would wish to be treated.
- Learn from mistakes, unlearn and relearn, and forgive personal mistakes so that progress can continue.
Preparing before a change arrives
Regulatory writers should know which new guidance is coming and how to implement it, monitoring agencies beyond the FDA when working globally. Understanding the therapeutic area, knowing current regulations and writing well remain basic requirements, while changing software, scientific developments and virtual teams create further learning and coordination demands.
Following a 2014 public-disclosure symposium, one writer considered three responses to the coming change.
- Ignore it and pretend it would not happen.
- Wait, then react.
- Prepare.
The writer chose preparation: assessing risks to ongoing and future projects, researching, discussing the change with colleagues, developing a strategy and informing the company. Despite colleagues’ initial scepticism, the writer was ready with knowledge, a plan and a workshop and became the company’s disclosure expert.
Keeping skills relevant
Writers should watch emerging industry trends, consider their implications for skills and help shape new opportunities for the profession. Changing tools do not remove the need to analyse scientific data, express results clearly and work with teams through leadership, communication and collaboration. Writers and managers should expand their skills, engage with new technology and enable teams to develop into changing roles.
Medical communication calls for thinking beyond filling templates and considering the relationship between data and messages throughout a programme’s life cycle. Scientific and clinical expertise, regulatory knowledge, communication and project management can support a wider scope of work.