One of my last postings was called “keeping Ken and Barbie out of jail,” an attempt to define some of the tasks involved working in medical affairs at a pharmaceutical company. One reader pointed out that I really did not define the job very well, and I promised to describe just what the job entails in an upcoming post.
While there is some variation in segmentation and structure, most pharmaceutical companies have two kinds of scientific teams: research / development and medical affairs. While R & D defines the scientific direction and early stage development, medical affairs provides scientific support for late stage development and post market support for drugs and devices. In small companies, the same team may be responsible for both kinds of activities.
Medical affairs usually functions alongside marketing, to provide technical support to both internal teams and external customers. So what kinds of tasks are involved?
1. Informational services – the scientists and physicians working in medical affairs generally act as disease experts. Activities range from educating department members, seeing that consumer questions are addressed, and providing informational services to health care providers in the community. Medical affairs also formulates publications plans, and the reporting of pivotal trial results to the FDA, at scientific meetings and through journal articles.
2. Regulatory review – medical affairs works with regulatory affairs and the legal department to insure that all written documents are accurate and adhere to the guidelines mandated by the FDA. All educational, technical and promotion materials are reviewed.
3. Liaison to health care professionals and professional organizations, and disease state advocacy groups. Medical affairs works to support the efforts of professional associations, patient support groups, and educational foundations.
4. Thought leader development — this involves providing information and other supports to persons who are recognized experts in their fields.
5. Educational meeting support — in the “olden” days, pharmaceutical companies actually wrote, staffed and sponsored continuing medical education events. Educational meeting support now only can be provided in the form of unrestricted educational grants.
6. Supporting marketing — medical affairs provides the scientific input and expertise in the design and construction of all promotional materials and events. At the least, materials are reviewed by medical affairs for scientific accuracy. Medical affairs officers may also present relevant scientific information at marketing functions.
7. R & D — depending on the structure of a company, medical affairs may also be responsible for all stages of clinical development including study design, initiation and monitoring. Medical affairs also may oversee the dispersal of funds and /or study drugs for investigator initiated trials.
8. Post market drug safety functions – in some companies medical affairs handles drug safety, reviewing individual adverse event reports, aggregate adverse event statistics, and sometimes even talking with customers about drug safety. (In some firms, these tasks fall under the egis of regulatory affairs).
9. Medical liaison – many companies have teams of medical liaison reps (MLRs) who are often field based medical information specialists, providing in depth drug and disease state information to health providers in their territories. They function as colleagues and experts in their fields. (Note that some companies may employ medical sales liaisons (MSLs) who, while providing services like MLSs, work within the marketing department).
As you can see, medical affairs encompasses scientific, informational, communications and interpersonal activities. A typical day is highly varied starting, perhaps, with a medical legal review session, followed by meetings with marketing, then reviewing preliminary data with the statistics group, and then attending a protocol review committee. Yes, a lot of time is spent in meetings and working in teams. If you are a reclusive lab rat type, medical affairs may test your people tolerance. It also helps to have a bit of an entrepreneurial bent, in order to understand the wants and needs of colleagues on the marketing side of the building. And much of the work depends on building relationships within and outside of the company.
I know that the descriptions above are rather brief. If you want any more detailed information about the functions of medical affairs, please ask and I will try to fill in the gaps.