Clinical Development is a key function within the Biopharmaceutical industry. Once a molecule has completed pre-clinical testing and basic safety questions have been addressed, the sponsor company will file an IND (Investigational New Drug) and if approved, Clinical Trials can begin. Clinical Development professionals have responsibility for the development and execution of the development strategy for assigned clinical programs.
Clinical operations are critical to the success of all studies in the pharmaceutical, biotechnology and medical device industries. Without a full clinical trial and positive data businesses are unable to commercialise their products.
Pharmaceutical, Biotech and Medical Device companies are commercial businesses that are licensed to research, develop, market and distribute medicines/devices. Once the investment into research & development is complete the businesses need to ensure they have the most effective commercial strategy to recuperate their investment and turn into profit. Another strategy is to license or partner their compounds/products to other businesses in the industry.
Market access is the method to make sure that all applicable patients who would benefit, get swift and continued access to the product, not only at the right price but also ethically. The market access professionals act as a liaison between the pharmaceutical/medical device companies and the government and healthcare organisations.
Medical affairs is a crucial function within the life sciences sector and it sits within the post approval activities of a company. It is the link between the industry and it’s stakeholders via the medical community. In medical affairs you will effectively link the science with commercial activity and are there to provide scientific and clinical support for commercial products. Medical Affairs professionals do this by managing the external relationships with the scientific community as well as patient groups, health authorities and Key Opinion Leaders.
Drug Safety/Pharmacovigilance is the practice of monitoring and preventing adverse effects in Patients within clinical trial and marketed products.
This is commonly viewed in two ways. Firstly the reporting, triaging and expediting of adverse events this is commonly run through Drug Safety Centres covering case processing.
Quality Assurance is a wide and varied function within the Pharmaceutical Industry to ensure that all products are created and tested and produced to the highest standard. This is commonly broken down to three core areas of GCP, GMP and GLP (Collectively known as GXP)
Regulatory Affairs is a key function within life sciences which ensures companies comply with the regulations and laws that apply to their industry.
Regulatory Affairs is a broad but specialist area which enables pharmaceutical/biotech/medical device companies to develop, market and maintain their compounds and/or products. In order for a business to comply with these regulations in an affective and timely manner they need the best talent working within this department.
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