Pharmaceuticals Organization Structure

The Organizational Design of a Pharmaceutical Company: Definitions, Roles & Responsibilities

Pharmaceuticals Organization Chart

Pharmaceuticals Organizational Structure Outline

Pharmaceuticals Organization Chart Template

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Pharmaceutical companies handle the research, production and delivery of pharmaceutical drugs to healthcare service providers (physicians, pharmacies, hospitals, etc.) and consumers. Pharmaceutical products must go through extensive research and testing (i.e., Research & Development), as well as follow regulations and obtain approval from government entities such as the Food and Drug Administration (FDA) before the products can reach its targeted market. Once products have been approved for large-scale distribution, Pharmaceutical companies scale-up manufacturing and align themselves with intermediaries to sell the drug through various channels (direct-to-consumer or through distribution channels such as pharmacies and hospitals).

Common Pharmaceuticals job titles: Chief Executive Officer (CEO), Chief Operating Officer (COO), Chief Financial Officer (CFO), Chief Medical Officer (CMO)

Research & Development

The Research and Development function is responsible for creating new medications and installing them in the disease-fighting arsenal of physicians. The process begins with "discovery," during which time researchers identify new candidates from a large library of chemical compounds. Thousands of such candidates are selected using modern computerized tools. After the candidates have been selected, they are tested for their ability to move through the body and interact with the desired pathology. Researchers then optimize the candidates by altering their chemical structures to increase their medicinal effects and to decrease their side effects. A phase of tests determines whether the drug is safe enough for human testing. By the end of these steps, only a handful of candidate drugs will remain. These are entered into clinical trials, which is the final and longest step.

Common Research & Development job titles: Research Scientist, Clinical Research Specialist, Research Assistant, Clinical Research Scientist

Clinical Trials

The testing phase of a new drug is a lengthy and expensive part of research and development. The Food and Drug Administration (FDA) demands that candidate pharmaceuticals pass through a three-phase process of human trials to demonstrate safety and baseline efficacy. The first two phases involve only small sample groups of test patients. The third phase involves a sample size of thousands of patients and carries huge costs. Generally, Phase III trials need to demonstrate that a drug meets the necessary efficacy requirements with a 95 percent statistical certainty.

Common Clinical Trials job titles: Research Investigator, Clinical Trials Research Associate, Clinical Research Coordinator, Clinical Cell Therapy Tech

Drug Discovery

Drug discovery is the process by which new disease or sickness-fighting compounds are screened and identified. This is the first step in new drug development. During this phase, compounds are identified and tested using criteria such as efficacy, stability and bioavailability.

Common Drug Discovery job titles: Drug Discovery Scientist, Immunology Scientific Investigator, Research Scientist

New Drug Approval

New drug approval from various regulatory bodies (such as the FDA) is the next step in bringing a drug to market, following a successful round of clinical trials. The regulators review rigorous statistical analysis and test results produced during the clinical trial phases. Some drugs may be "fast-tracked" if they treat a serious condition that does not currently have many viable treatment options. After a new drug has been approved, it is ready to move into the manufacturing process.

Common New Drug Approval job titles: Regulatory Specialist, Regulatory Affairs Associate, Clinical Regulatory Associate

Post-Approval Research & Monitoring

During post-approval research & monitoring, Pharmaceutical companies continue to collect data on the efficacy and use of a drug after it is approved and manufactured. They monitor factors such as safety, long-term side effects and potential secondary uses for the drug. Continued research can identify additional clinical value (new methods of delivery, combination of treatments, new uses, patient targeting, etc.). for drugs that have already been approved.

Common Post-Approval Research & Monitoring job titles: Clinical Research Monitor, Clinical Research Protocol Monitor, Post-Approval Compliance Monitoring Specialist

Pharmaceutical Manufacturing

The Pharmaceutical Manufacturing function is responsible for producing drugs on an industrial scale following testing (clinical trials) and regulatory approval. The process of manufacturing pharmaceutical products includes many unique components, including chromatography, milling, coating, granulation and pressing. Other facets of the pharmaceutical production process, such as batch integrity testing, quality assurance and facility maintenance, are common to other manufacturing operations. In some cases, pharmaceutical manufacturing groups may produce active pharmaceutical ingredients (APIs), while other manufacturers might purchase APIs in bulk from a third party and prepare them for consumption by adding certain compounds, binders and/or fillers.

Common Pharmaceutical Manufacturing job titles: Production Chemist, Pharmaceutical Process Engineer, Pharmaceutical Manufacturing Engineer, Biotech Production Specialist

Pharmaceutical Distribution

The Distribution function within the Pharmaceuticals industry is responsible for supplying drugs to pharmacies, hospitals and other healthcare facilities. In most cases, drug distribution is carried out by third parties that link manufacturers (pharmaceutical companies) with retailers (pharmacy and hospital networks).

Common Pharmaceutical Distribution job titles: Quality Assurance Specialist, Warehouse Material Handler, Distribution Technician

Product Education & Compliance

The Product Compliance function is responsible for the final licensing of a drug (after clinical trials) and the subsequent labeling, education and information management related to that product. They ensure that products are labeled in accordance with requirements set forth by the Food and Drug Administration (FDA) and fact-check marketing/promotional materials that are used to market the drug to physicians and potential patients. In some cases, the product compliance group may audit company operations (manufacturing, drug testing, etc.) to ensure that all operations are in compliance with industry regulations.

Common Product Education & Compliance job titles: Medical Information Specialist, Product Compliant Specialist, Medical Writer, Medical Editor, Clinical Operations Document Specialist

Patient Assistance Programs (PAPS)

Patient Assistance Programs (PAPs) are initiatives funded by pharmaceutical companies to distribute free or reduced-rate medicines to people with low to moderate- income or who are underinsured. The eligibility requirements for these programs may vary; some programs demand that the patient be uninsured, while others require that certain income levels are met. PAPs have been in existence since the 1990s, and have helped roughly 7 million patients since 2005, according to statistics kept by the Partnership for Prescription Assistance.

Common Patient Assistance Programs (PAPS) job titles: Financial Assistance Representative, Patient Assistance Counselor, Patient Assistance Coordinator, Patient Advocate