A Day in the Life of a Scientific Jack-of-all-Trades
Career Story Blog Post By Christine (Crisy) Sanfilippo, PhD, Manager, Pharmaceutical Medical Affairs at Bausch & Lomb, a division of Valeant Pharmaceuticals
What exactly does a job in Medical Affairs entail? I had the same question when approached by a colleague at Bausch + Lomb, wondering if I would be interested in an open position in that department. So when asked to write this blog post, I figured I’d share with fellow scientists my view of Medical Affairs and the tasks performed during an “atypical” typical day at my job.
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. Thus, Medical Affairs can be broadly defined as “the department within a pharmaceutical or medical device company that interacts with physicians and other healthcare professionals (HCPs) who utilize or are involved with research related to the companies' products.” In reality, since Medical Affairs encompasses scientific, informational, communications and interpersonal activities, I think “scientific jack-of-all-trades” is a more appropriate description.
The Federal FD&C Act prohibits the introduction of drugs into interstate commerce for any intended use that the FDA has not determined to be safe and effective. However, once a drug has been approved by the FDA, HCPs can lawfully use or prescribe that product for use or indication not included in the labeling. Since the FDA recognizes that off-label uses may be important therapeutic options, companies are permitted to respond to unsolicited requests from HCPs about unapproved or off-label uses, and managing these responses compliantly constitutes a large part of my job. Not only do I administer our information database and compose standard responses to common inquiries, I liaise with the Customer Service and Pharmacovigilance departments to answer technical questions from consumers, and review individual adverse event reports regarding the safety of our products.
Thus, the majority of my daily activities involve informational services. In addition to medical responses, I formulate publication plans, perform data analysis and interpretation, prepare abstracts and posters for presentation at scientific meetings, and write/review/submit manuscripts for publication in target journals. I correspond with external authors, track the progress of post-launch studies and investigator-initiated trials (overseeing the dispersal of funds and/or study drugs), and assist in the reporting of company-sponsored trial results to the FDA.
Several of my other job responsibilities involve interacting cooperatively with the Regulatory Affairs, Legal and Marketing departments in various different functions. This includes the design and construction of promotional materials and events, reviewing written documents for accuracy, presenting relevant scientific information at marketing functions, helping legal personnel to understand the science behind potential patentable inventions, and assisting colleagues with geographical product expansions according to foreign regulatory agency guidelines.
Another part of my job involves creating and delivering impactful presentations on our company’s products to audiences ranging from external vendors to entry level sales personnel. This includes providing in-depth training materials for our Medical Affairs colleagues, the field-based medical science liaisons (MSLs), to facilitate their interactions with HCPs in their territories.
Medical Affairs, in my opinion, is a logical next-step for someone who is knowledgeable about the technical science surrounding healthcare products, but wants more exposure to the “business” side of that science. As you can see, a typical day is highly varied, and a lot of time is spent in meetings and working in teams, so “people skills” are a must. My advice? If you are interested in a career in industry, and would like to complement your science background with a little bit of “this” and a little bit of “that,” consider exploring opportunities in Medical Affairs and become a scientific jack-of-all-trades!
Tracey Baas |