Pharmacists have a broad understanding of the development process of a medicine, its pharmacology and formulation, its clinical use and side effects. They are therefore able to succeed in many different roles within the pharmaceutical industry (see here for some examples). Furthermore, the ability of pharmacists to understand the basis of a certain pharmacological approach and to explain its therapeutic use and practical implications are particularly useful with respect to the many innovative therapies that have entered the market in recent years (e.g. CAR-T therapies).
Medical Affairs and Medical/Scientific Advisors
Medical Affairs is one of the three key strategic pillars of a pharmaceutical company (along with Commercial and Research & Development) (see here a McKinsey report on “A Vision for Medical Affairs in 2025”). Medical Affairs is a critical partner in ensuring the success of the company’s medicinal products, including successful product launches based on scientific excellence. Medical Affairs also acts as the recognized voice and conscience of the patient within the company.
Roles in Medical Affairs have traditionally been covered by medical doctors, but in recent years a new trend is emerging to include pharmacists in these highly specialised professional positions. Examples of possible interesting roles for pharmacists within the Medical Affairs structure of a pharmaceutical company include Medical Advisor, Medical Information Specialist, Medical Science Liaison, Medical Education Specialist, Medical Affairs Operations and Compliance Specialist. A very significant new development in the UK has been the expansion of the role of Nominated Signatory to include registered pharmacists.
The role of Medical Advisor, for example, involves being the scientific expert on the clinical use of a medicinal product and working closely with commercial colleagues on scientific communications with healthcare professionals. The role also involves the management of post-authorisation clinical studies and the scientific training for the sales force. Medical Advisors also maintain peer-to-peer contacts with key opinion leaders.
The Nominated Signatory
The UK Code of Practice for the Pharmaceutical Industry, independently administered by the Prescription Medicines Code of Practice Authority (PMCPA) now includes UK registered pharmacists within the professionals entitled to assume the role of Nominated Signatory (see here and here more details). This role is involved in the certification of all promotional and educational activities and materials produced by pharmaceutical companies for use by healthcare professionals and patients.
The role of Nominated Signatory is a critically important one, that carries a significant amount of responsibility. Pharmacists who take on this role are required to have appropriate product knowledge, relevant experience, length of service and seniority plus an up-to-date and detailed knowledge of the Code. All qualifications and details of signatories have to be notified to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), as well as to the PMCPA.
The Compliance Specialist
Checking for the compliance of all processes within a certain company or organisation with respects to regulatory requirements and standards is the main duty of the Compliance Specialist. This role requires a deep knowledge of pharmaceutical legislation and regulatory guidances. Internal auditing may also be a key activity to be performed, together with the identification of strategies to solve any compliance issues and the monitoring of the relevant legislation. This role is also connected to the Nominated Signatory role, as it has to confirm compliance of all promotional and marketing materials to the regulatory requirements. It may be a good transition role for a pharmacist wishing to become Nominated Signatory.
The Medical Science Liaison
This role, often described as MSL, is responsible for establishing and maintaining scientific relationships with key opinion leaders (physicians, academic researchers, etc) within a specific geographic area. The roles are focused on a specific therapeutic area and support the correct use of medicinal products within the area. MSLs also provide scientific information and advise on latest developments and new clinical data. The ability to keep up-to-date with the scientific knowledge of their therapeutic area is a key requirement to cover the MSL role. MSLs are field based to travel within their assigned geographic area to keep in contact with key opinion leaders, and the roles have a good level of autonomy and flexibility compared to other roles in medical affairs.
The Medical Information Specialist
MIS often represents an entry role for pharmacists into the pharmaceutical industry, particularly for pharmacists who have worked in other sectors (e.g. community or hospital pharmacy). Medical Information is responsible for answering clinical and scientific questions from healthcare professionals (including physicians and pharmacists), and patients. As seen for the MSL, it is important to be able to clearly understand and explain the clinical and pharmaceutical use of medicines, combined with experience of analyzing scientific data. Medical Information also involves writing scientific summaries of the data on a particular topic, which can be used to respond quickly to questions from healthcare professionals. The UK has seen the development of specialised contact centres for Medical Information services to answer first line questions coming from patients or healthcare professionals. Roles within pharmaceutical companies have become more specialized as a result, dealing with the complex questions and generating resources to be used in responding to questions. There has also been a growth in the use of digital communication channels to provide information to healthcare professionals.
Closely related to the MSL and MSI roles are also Medical Education Specialists (MESs), whose focus is on the provision of medical education resources on a specific product or therapeutic area to both healthcare professionals and patients. This may also occur through the use of a mix of different media and communication channels, i.e. web platforms, social media, etc.
Medical Affairs Operations
This role is responsible for the coordination of all the different activities included in the Medical Affairs function and organisational structure. The development and implementation of medical affairs strategies is a typical role, together with the monitoring of performance and the procurement of all needed resources (both materials and human). Skills in project management are highly advisable to success in these positions, which involve very complex cross-functional networking with a variety of teams and activities.