Medical Affairs has originally emerged as a reaction because of increasing pressure from regulators to separate Medical and commercial functions. Companies have been experiencing increasing internal demand to focus on generation and development of new products rather than managing products after FDA approval. Thus Medical Affairs has evolved into a separate medical organization that often sits within development organizations but primarily works on post approval activities and has both the scientific and clinical expertise to support commercial products.

Medical affairs services address typical concerns about commercial drug products, comprising safety, efficacy, dosing, and administration. At the time of launch, medical affairs are often the primary recipients of questions from patients, healthcare providers, and other interested parties. Hence they must be equipped with fair and balanced, prewritten letters that accurately describes the information a company has about each newly approved agent. In addition, Medical Affairs Services also play active role in the development of commercial materials and/or sales training.

The Medical affairs services must possess leaders who are conversant with whole drug development process. They should be able to take multiple therapeutic areas into account when assessing clinical value and adopt an independent view when analyzing risk versus benefit. In addition they must also be technologically savvy. Medical affairs services direct the plans for all drug-related publications such as abstracts, posters, and manuscripts. Such communications are essential for product commercialization. The group is also responsible for developing a strategic plan that integrates and aligns the timing of clinical trial data locks, and the release of key data points at scientific meetings. Such plan outlines the timing of abstract submissions and defines when key manuscripts can and should be published in the years leading up to and following a launch.

Another key role for medical affairs services is to develop clear and consistent language to describe clinical results of the studies as a whole for the organization. A publication plan is even more critical after drug approval when a new product faces a competitive environment and medical communities begin to incorporate it into their therapeutic programs. Each initiative needs to be planned and carefully coordinated to maximize the amount of exposure, recognition, and buzz for a new drug product.

Medical affairs Company need to engage in lifecycle planning with commercial and product development leaders. This involves keeping medical affairs services in sync with the rest of the organization and preventing needless divisions, wasted effort, irrelevant trials, and missed opportunities. They must be able to work effectively in matrix organizations by collaborating with cross-functional leaders and driving change without the reporting structure to impose it. Medical affairs leaders are key resources within medical affairs for both Medical Science Liaisons (MSLs) and commercial teams. MSL team is uniquely positioned as the “medical” face of the company in a way that is very distinct from its sales organization. It often has strong ties with both community and academic physicians and can be an effective conduit for a flow of information both out to a medical community and into a company itself. Internally, because of the bridge-like nature of medical affairs, MSL team can use its strong relationships with other major corporate departments to help external parties understand and navigate internal waters.

WorkSure^@reg; Medical Affairs Pharmaceutical Company has most competitive, knowledgeable and technologically sound Medical Affairs Associate team which has the capability to work through all phases of product life cycle and across the therapeutic areas.

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