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Medical Affairs

Medical affairs is the part of a pharmaceutical, biotech, or medical device company that talks with physicians and other healthcare professionals about the science, not about a sales target. The team explains clinical data, answers questions that go beyond a sales call, gathers what those experts are seeing in practice, and helps decide what evidence the company still needs. The people in the role are often physicians, pharmacists, or scientists. Their job is a scientific conversation that stays non-promotional.

Quick answer: Medical affairs sits between research and the clinic. Clinical teams run the trials. Commercial teams sell the product. Medical affairs takes the evidence to the people who treat patients, brings their questions back, and keeps that exchange inside the rules that separate science from promotion.

What medical affairs is for

A new medicine reaches the market with a label, a set of trials, and a lot of questions the trials did not answer. A community oncologist wants to know how the data apply to an older patient. A payer committee wants to know what happens in ordinary practice. An investigator wants to study a dose the company did not test. None of those conversations belong in a sales pitch. Medical affairs is the group that holds them.

The work is not one job. A medical science liaison meets external experts and records the scientific exchange. A medical information team answers product questions that come in by phone, email, or a form. A medical director sets the scientific priorities for a therapy area. Other people plan evidence, congresses, speaker programs, or scientific account work. They share one constraint: what they say has to be accurate, balanced, and separated from promotion.

Medical affairs, clinical affairs, and commercial

Clinical affairs, or clinical development, designs and runs the studies that produce the data. Medical affairs reads those results, explains what they mean for practice, and notices the questions clinicians keep asking. Those questions can become the next study, a response document, or a change in what the field team is prepared to discuss.

Commercial teams are measured on prescriptions, contracts, and revenue. Medical affairs is not. A medical science liaison can meet the same physician a sales representative meets, and the two conversations are different. The sales conversation is about the product as promoted. The medical conversation is about the data, the disease, and questions the physician raises. Mixing them is how a company gets into trouble with regulators and with the physicians it needs to trust.

That line is why companies keep a written record of scientific exchange, route off-label questions to medical information, and pay external experts under a fair-market-value cap. The glossary entries on scientific exchange, medical information requests, and fair market value cover those pieces.

What the team does across the life of a product

Before approval, there is no label to teach. The medical plan is about evidence gaps, which experts the company still does not know, and when a field team should be in place. That stretch is what people mean by launch excellence. A key opinion leader may already be an investigator on the pivotal study. Mapping and tiering those experts is a medical affairs job, not a sales-targeting job. KOL tiering is the ranking step after the experts are identified.

After approval, the day-to-day work is the visit, the question, and the meeting. An MSL meets an expert, writes down who raised each topic, and routes an unsolicited question or a safety comment to the team that owns it. Medical information answers the question from an approved response. At a medical congress, the team decides which sessions matter and writes the note in the room. When the company itself hosts a program, a speaker, or an advisory board, that is a different record, with a contract and a payment cap.

Some of the work is not a single visit. An investigator-initiated study is research an external physician proposes. A non-interventional study watches patients treated in ordinary practice. An integrated evidence plan is where the company writes down which of those gaps it will fill, and which it will not. On a health system, medical affairs may also keep a scientific account plan for the clinicians and committees that set a pathway, kept apart from the commercial account plan.

What medical affairs is not

It is not the sales force, and it is not a softer name for promotion. It does not replace clinical operations, pharmacovigilance, or the regulatory team that files with an agency. A safety comment heard in the field is reported through the company's pharmacovigilance process. Medical affairs records that the comment was made. It does not run the safety database.

It is also not one software category. Teams still use a CRM, a medical-information system, a congress plan, and a spreadsheet of studies. The function is the people and the rules. Software is how the record survives after the meeting.

Where TikaMobile fits

TikaMobile makes software for this work. The products can be used together or beside a CRM the company already runs, including Veeva or Salesforce. They do not replace that CRM.

TikaMSL is the medical affairs CRM for medical science liaisons: the expert, the scientific visit, and the inquiry captured on that visit. TikaMedInfo is the medical information case after that inquiry is in a queue. A person still reads the request and sends the response. TikaInsights is where a field observation becomes an insight, with a theme and an action a manager can verify. TikaConference is congress coverage. TikaSpeaker Bureau is the programs the company hosts. TikaStudies is the portfolio of investigator-initiated studies, sponsored evidence, and research collaborations. TikaValue and Outcomes is the scientific account plan for health systems and payers.

The medical affairs pages on this site describe each of those products. This entry is the definition of the function.

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Questions people ask

What is medical affairs in pharma?

Medical affairs is the scientific function that discusses clinical evidence with healthcare professionals, answers their questions, and brings what they are seeing in practice back into the company. It is separate from the sales force and from the clinical team that runs the registration trials.

How is medical affairs different from sales?

Sales is accountable for promoting the product within the approved label. Medical affairs is accountable for a non-promotional scientific exchange. An off-label question raised by a physician is handled as a medical information request, not as a sales conversation.

How is medical affairs different from clinical affairs?

Clinical affairs generates the trial data. Medical affairs explains that data to people who treat patients and identifies the questions the trials left open. Those questions can shape later evidence, but medical affairs does not run the pivotal trial.

Who works in medical affairs?

Medical science liaisons, medical information specialists, medical directors, and people who plan evidence, congresses, or scientific accounts. Many have clinical or scientific training. The common job is the scientific record: what was discussed, what was asked, and what the company did next.

May 16, 2025

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