Contract Research Organisations, otherwise called as CROs, provide contract-based services for Pharmaceuticals, Biotechnology and Medical devices companies at various stages of their drug development. The activities that a CRO undertakes include preclinical studies, clinical research and clinical trials, regulatory activities, and pharmacovigilance. CROs have technical competency and expertise in performing these activities. The company that outsources these overwhelming activities to a CRO is called a sponsor or client company. The CROs add value to the sponsor companies by reducing the time required to bring the drug into the market.
CRO’s usually hire highly qualified personnel holding life science related degrees. Among the various staff, medical writers play a crucial role in a CRO in handling the variety of documents involved in the drug development and its reporting. A medical writer who understands the drug or device development process and regulatory activities is an important asset for the team. The key function of a medical writer is to develop accurate, clear, and compliant documents as per the project and the regulatory requirements.
A medical writer in a CRO is required to create and maintain a wide spectrum of documents, few of them include:
Medical writers in CRO collaborates with bio-statisticians, medical specialists, scientific experts and sponsors to develop high quality documents abiding to the ICH GCP requirements. Here are few considerations to be hired as a medical writer in a CRO:
CROs usually aim to proliferate the markets with their newly launched products, and preparing these communication materials becomes crucial for creating the identity for the products. Medical writers perform a key role in enabling this process. If you are the one who is looking out for an adventurous profession and are good in juggling multiple works, medical writing is the profession you must explore!