Perspectives in clinical research
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Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes preparing regulatory, safety, and publication documents as well as educational and communication material related to health and health-care products. Medical writing requires medical understanding, knowledge of drug development and the regulatory and safety domains, understanding of research methodologies, and awareness of relevant regulations and guidelines. ⋯ However, the current share of India in global medical writing business is very small. This industry in India faces some real challenges, such as the lack of depth and breadth in domain expertise, inadequate technical writing skills, high attrition rates, and paucity of standardized training programs as well as quality assessment tools. Focusing our time, attention, and resources to address these challenges will help the Indian medical writing industry gain its rightful share in the global medical writing business.
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The medical writing industry is on an upwards growth path in India. This is probably driven by an increasing urgency to have high-quality documents authored to support timely drug approvals, complemented by the realization that the competencies required are available in emerging geographies such as India. This article reviews the business landscape and the opportunities and challenges associated with outsourcing medical writing work India. It also analyzes the core competencies that a medical writer should possess and enlists various associations supporting learning in this domain.