Building writing capability in emerging markets
Writing capability depends on recruitment, training, supported experience and quality systems. A shared team can also serve several markets by adapting common material to local requirements.
Recruitment and training
A qualified talent pool does not itself ensure high-quality documents that are right first time. A 2013 account of medical writing in India identified insufficient professional writing experience and difficulty finding the right combination of skills among qualified English-speaking recruits as important challenges. The authors' 2008 survey had found that more than two-thirds of the Indian medical writers surveyed were physicians and over 90% had a life-science background.
The 2013 account advocated selecting suitable talent, providing well-designed training and opportunities to develop through cost-effective, process-driven, scalable systems. It described employers recruiting and training writers rigorously to meet global standards. Interviewed industry leaders also called for English-language proficiency to develop alongside writing expertise, while recognising growing demand for other languages and the importance of quality in any language.
Comparisons based only on nationality can obscure differences in experience: one industry leader in the 2013 account knew many more writers with decades of experience in the West than in India, but saw little difference between new writers. That leader attributed a steeper learning curve partly to an educational tradition with less emphasis on research and independent working.
Training recruits from entry level to experienced writing requires time and money. A 2013 account of regulatory writing in China and Japan warned that Japanese writers' knowledge and capabilities could vary regardless of their years in the role. Its assessment of China identified biomedical manuscript writers and translators as a potential regulatory-writing pool with suitable training, supplemented by people returning from overseas study or work with biomedical knowledge, bilingual skills and sometimes pharmaceutical experience. For Japan, it described exposure to global studies and standards as helping writers meet client and regulatory needs, and recommended training younger writers to sustain future capacity and quality.
A shared centre across markets
A 2013 medical-communications proposal addressed companies unable or unwilling to maintain comprehensive local teams in every emerging market. Large companies could have local sales and marketing teams without enough staff for the communications work, while smaller companies might not invest in a full operation in each country. The proposed centre of excellence would hold common product material and distribute it across markets with local customisation, including translation.
The proposal identified six challenges that the team would have to address.
- Differences in demography, culture and language.
- Local health-policy and regulatory variation.
- Different healthcare facilities and insurance arrangements.
- Limited local staffing with current domain knowledge.
- Gaps in infrastructure and technological support.
- Limited knowledge of population disease profiles.
The expected benefit was synergy from preparing shared material that could be adapted for local use, with the team's knowledge of market culture and infrastructure contributing alongside writing skills.
The capabilities behind the hub
The Indian hub proposal in 2013 drew on medical and scientific knowledge, communication and analytical skills, literature-database experience, familiarity with data-management systems and international experience. It attributed the development of quality-control and quality-assurance methods partly to experience with mature regulatory agencies. Professionals returning from education or employment in North America or Europe were described as developing specialist domains and strengthening international networks.
The account also described writers building expertise through changes of job and document type, often starting with clearly defined assignments, stringent style guides and timelines, and material collated from clinical and regulatory contributors. It proposed that experience in a non-native-English-speaking setting and additional language learning could support adaptation and future translation services for other emerging markets.