Career Overview: Pharmaceuticals

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Posted by The Editors on December 3, 2012
Overview
Pharmaceutical companies make medicines from plant- and chemical-based compounds. They work to prevent the spread of disease, ease pain, cure illnesses, and slow the effects of aging, among many other things. Pharmaceutical companies' mission to discover the next groundbreaking medicine is a big cause steeped in big bucks, big competition, and, at times, big controversy. Insiders refer to the handful of multinational giants that dominate the industry-Pfizer and GlaxoSmithKline, to name two of the largest-as Big Pharma. Many firms also produce animal health products, livestock feed supplements, vitamins, and a host of other goods.

The majority of Big Pharma companies are headquartered in the United States, but several are based in Western Europe-specifically the United Kingdom, Switzerland, Germany, and France. Most pharma companies headquartered in the United States are located east of the Mississippi, with the greatest concentration in New Jersey.

Depending on their size and strategy, pharmaceutical companies conduct extensive in-house research or may seek to license promising drugs from academia, other pharmaceutical firms, or biotechnology companies. The latter are generally smaller than their Big Pharma competitors, and employ cellular and biomolecular processes to make medicines or diagnose illness.

Growth at a Price:

Pharmaceuticals is one of the world's most profitable industries. During the last 30 years, the industry has spent billions of dollars on research and reaped billions in return. In 2008 alone, the pharmaceutical industry sold $773 billion in products worldwide-a number that has consistently grown for the past 8 years and is projected to increase again by 2.5 to 3.5 percent in 2009, according to the drug market research firm IMS Health.

But the process that turns research dollars into medicines is a slow and often arduous one. It now takes an average of 12 to 15 years and up to $1.7 billion for a drug to go from discovery to market, according to The Pharmaceutical Research and Manufacturers of America. And despite all the time and money invested, only a handful of drugs are approved by the FDA each year.

The arduous drug approval process reveals a central fact about Big Pharma: it's one of the most intensely regulated industries in the world. The U.S. Food and Drug Administration (FDA) and its European Union counterpart, the European Medicines Agency (EMEA), govern every aspect of a drug's development-from chemicals used in the drug and clinical study instructions, called protocols, to packaging components and marketing materials. This strict oversight is meant to protect patient safety, and pharma companies take regulatory oversight seriously. The constant pressure to adhere to government mandates shapes every aspect of a pharma firm's organization, operations, and culture. For example, drug companies maintain powerful regulatory affairs divisions-the departments that deal with government agencies-and they tend to be risk-averse.
Job Outlook
There will always be a need for pharmaceuticals, and the industry has been expanding worldwide. Several factors could negatively affect the industry in the near future, however, including healthcare reform, expiring drug patents resulting in less expensive generics on the market, and rising research and development costs and regulations.

Economic troubles in 2008 led to several acquisitions of smaller companies by several large drug companies, which resulted in the announcement of some major layoffs. In 2009, Merck took over Schering-Plough and predicted that 15 percent of its workforce would be cut, and Pfizer bought Wyeth in a move that could eliminate nearly 20,000 jobs. Industry experts predict the cost cutting will continue, meaning that non-essential administrative and sales positions in the industry may be harder to come by. Science- and engineering-related positions, however, will most likely remain in high demand.

In terms of sales positions, recent growth has resulted in increased competition. The problem seems to be that too many sales reps are competing for physicians' attention. In the past decade, the number of U.S. pharmaceutical sales reps has tripled while the number of physicians has grown little in comparison. And the product pipeline is generating more specialty products and fewer mainstream blockbuster drugs, leading Big Pharma to shift its sales focus from primary care physicians to the less numerous specialist physicians (such as oncologists) who are the gatekeepers for dispensing specialty drugs. As specialty selling increases, reps with science degrees will likely be in high demand.

Job requirements for science positions have become more stringent as well due to higher numbers of applicants. Internship experience, advanced or specialized degrees, and proven communications and leadership skills will definitely make you a more appealing candidate. While a graduate degree isn't required to land a job, it allows greater flexibility in the job market.

Another industry trend is the move toward using the Internet and other technologies to provide interactive marketing and direct-to-patient education. Consequently, people with Internet marketing experience may find extended opportunities in Big Pharma.
Career Tracks

Research Positions
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Research positions deal with the process of drug discovery and testing. The entry-level job title in most pharmaceutical companies is lab technician. The work can be somewhat tedious, but a lab tech position can be an excellent way into the industry.

If you've got a BS or MS degree in biochemistry or a related discipline and have previous lab experience, either in school or in the industry, you can generally find work as a research associate. Research associates do real science, conducting experiments and analyzing data under the close supervision of more senior scientists. Research associates often have a number after their title (for example "Research Associate II") to indicate seniority level. Above the research associate is the research specialist (this title varies somewhat-it's sometimes called pharmaceuticals specialist, among other things), who generally has more autonomy and creative input into his or her research than the associate does.

PhDs who have completed their post-docs typically enter as associate scientists. In rare instances, research specialists without PhDs are promoted to this level. Associate scientists have considerable autonomy over their own research, though they collaborate fairly closely with a supervisor. The step after associate scientist is scientist-a position that involves running the lab and planning and executing large-scale research projects. Above the scientist is the senior scientist, who oversees the work of several scientists but no longer works in the lab.

Scientists at all levels have the option of leaving the research track for management-track positions. Insiders say that for employees who don't have PhDs (and don't intend to go back to school to get one), the management track holds much fewer opportunities for promotion than the non-PhD research track.

Lab Technician

Lab techs perform the routine maintenance tasks- cleaning and maintaining glassware, working with animal colonies, operating lab equipment, and so on-that are needed to keep labs functioning. Only a high school diploma is required, though many people with college degrees start here as well.

Research Associate

A BS or MS in biochemistry or a related discipline and experience working in a lab are typically required to land this job. Associates work at the bench, conducting experiments under the guidance of PhD scientists. If you're coming out of school with some lab experience but no PhD and you want to work in R&D, this is the job for you.

Research Scientist
After receiving a PhD and completing a post-doc, a scientist can get a job as a research scientist (sometimes the initial title is "associate scientist"), designing and conducting experiments and writing up results for publication when appropriate.

Clinical Development and Medical Jobs:

A variety of medical and scientific specialists at pharma companies perform the numerous studies required to take clinical compounds from the lab bench to the pharmacy shelf. Physicians with director or VP titles head up a pharma company's therapeutic divisions and are responsible for ensuring drug safety and for keeping development programs on track. MDs and sometimes PhDs or PharmDs are responsible for drawing up a particular product's overall clinical development plan, which is a strategic and tactical document that lays out the studies a company intends to perform before it applies for marketing approval. They also write or contribute to clinical trial protocols, the instructions for an investigator describing the objectives, design, and methodology of a clinical trial.

Once the plans are approved by regulatory authorities, clinical research associates (CRAs) take over the nitty-gritty of working with investigators to conduct clinical trials. Depending on the research objectives, these trials may be confined to a small patient group at a single site, or they may involve thousands of patients at hundreds of sites worldwide. Typically RNs, CRAs get involved early on by helping to write study protocols. As a clinical trial proceeds, they meet with investigators and their staff to ensure that the study protocol is being followed, and they also monitor the collection of patient data.

One thing to note: Many pharmaceutical companies outsource the conduct of some or all of their clinical trials to companies called contract research organizations (CROs). If you work in clinical development within Big Pharma, interacting with CROs will be an important part of your job. Likewise, if you're an MD, PhD, MS, RN, or PharmD interested in working in clinical development, you may find that CROs offer engaging and rewarding career opportunities similar to those offered within Big Pharma companies.

Clinical development offers other career options, too. Regulatory affairs experts (typically scientists at the master's or PhD level, or with public health training) are the liaisons between industry and government. Most companies divide regulatory affairs into two divisions-one that deals with clinical development, and another devoted to the composition and quality of the pharmaceutical products. Both divisions communicate directly with government regulatory bodies and manage great volumes of paperwork.

Clinical Research Physician

Clinical Research Physicians (CRPs) are MDs who develop and implement plans for ushering experimental drugs through preapproval clinical trials. They work on cross-functional teams to maximize understanding of the pharmacological, regulatory, and clinical dimensions of the drugs being studied.

Clinical Research Associate
These are the folks who oversee clinical trials. They get involved in designing protocols, enlisting physician investigators, training clinic personnel, and evaluating data. The job can require travel, sometimes as much as 80 percent of the time, but it doesn't always. CRAs may also manage the services of an independent clinical research organization that runs the actual studies. A BS, BSN, or RN is required.

Regulatory Affairs Associate
The regulatory affairs career path suits job seekers who have a background in science but don't want to do lab work. Regulatory affairs specialists complete the paperwork required by regulatory agencies worldwide and communicate directly with the agencies to ask questions and resolve issues. Depending on their level of industry experience, they may also set regulatory strategy for a pharma company. A master's degree is typically the minimum requirement for entry-level positions.

Bio Statistician
Statisticians in clinical development prepare analysis plans for clinical studies, design tables and figures that display information clearly, interpret final study data, and write the statistical sections of clinical study reports. As with research scientists, statistician titles frequently include a I, II, or III to indicate levels of education and experience. Entry-level positions require a master's degree or PhD in statistics or a therapeutic specialty; higher levels require a PhD and several years of industry experience. Biostatisticians ultimately report to the head of a therapeutic division at most companies.

Clinical Data Manager
Clinical data managers supervise all aspects of clinical data. They specify how metrics will be collected and assist in standardizing data management procedures for internal operations and external reporting. This position typically requires at least a master's degree in a relevant area plus several years of industry experience.

Medical Science Liaison
Medical Science Liasons (MSLs) are field-based MDs, PhDs, or PharmDs with therapeutic area specialties. They interact with physicians and scientists in the health care community-especially those doing prominent academic research-to maximize the acceptance and proper use of company products.

Manufacturing and Quality Assurance Jobs
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A variety of engineering types-biochemical, electrical, environmental, industrial, mechanical, and software engineers-as well as scientists can find work in Big Pharma in the manufacturing arena. Roles include designing the manufacturing processes for drugs, ensuring the integrity of finished product, creating product packaging, and planning specialized workspaces.

One area that gets a lot of attention in pharmaceuticals is called quality assurance and control, often shortened to QA/QC. Quality experts ensure that medicines are manufactured and studied in compliance with federal standards. They examine production plants, monitor investigator sites, audit study data, and validate manufacturing processes and computer systems. If you've got a BS, a BE, or higher in a relevant discipline, you will find many opportunities here.

Like scientists on the pure research side, many employees in manufacturing and QA/QC encounter a dual ladder in Big Pharma. Engineers and scientists can get promoted doing technical work or, if they have the aptitude and inclination, can shift over and become part of the management team that coordinates the work of the technical folks.

Process Engineer
In most cases, process engineers work on project teams with more senior engineers. Job responsibilities may include designing chemical or biological methods for mass-producing compounds, designing equipment, and designing and overseeing the construction of various elements of manufacturing plants from pilot to commercial scale.

Quality Control Analyst

Quality Control (QC) analysts are responsible for the biological and chemical evaluation of products, materials, and facilities. They perform assays and establish and write specifications and standard operating procedures. Most people who fill this role have a BS. This position is often a good fit for job seekers who have backgrounds in science and like to work in highly structured settings.

Quality Assurance Specialist
Quality assurance (QA) specialists ensure that a company's testing, reporting, and manufacturing are in compliance with regulatory requirements. They conduct site audits and review and analyze data and documentation. The entry-level position typically requires a BS.

Business Operations Jobs:

Business operations encompasses the diverse array of commercially oriented positions within a pharma company, plus the standard corporate positions in areas such as finance, HR, and purchasing. If you've got an MBA, this is where you'll find the most opportunities-especially if you've got a bachelor's degree in a scientific discipline, which can demonstrate you'll move up the learning curve quickly in the complex industry of pharmaceuticals. A BS is not necessarily required, however, if you've got some industry experience or can prove you're the right fit for the organization.

Within marketing, there are analyst positions galore, covering specifics such as market research, forecasting, and promotional response analysis. These are excellent entry-level positions for MBAs without industry experience. One step up and requiring some pharma experience are assistant or associate product managers, who execute a brand's strategy under the direction of a product manager. Product managers are responsible for the overall success of a brand. They work with a therapeutics-focused business director or other representatives from upper management to set performance targets, then design an appropriate marketing strategy. While most product manager positions require an MBA, at some companies they may also require industry sales experience. Without it, you may need to arrange a rotation program in the field, or you'll find yourself competing unsuccessfully with internal sales reps vying to move up the corporate ladder.

Market Research Analyst
Market research analysts collect and analyze data to support the marketing of medicines during every stage of the product life cycle, including pre-launch, launch, and when the products become established. They design and conduct market research studies, analyze accumulated data, and communicate findings to management to support business recommendations. MRAs usually work closely with product managers. This position requires a bachelor's degree in business, social science, or a related field; an MBA is frequently preferred. Some travel may be required in order to oversee field research.
Salary range: $46,000 to $75,000 (more for MBAs with industry or sales experience)

Associate Product Manager
Associate product managers are primarily responsible for coordinating and implementing campaigns for specific drugs, audiences, or both. This involves a little strategy and a lot of execution-things like developing collateral pieces, working as a liaison to advertising agencies, and establishing a company presence at conventions. Many MBAs enter the industry this way; other people come to this position from sales.

Product Manager
This job requires managing a team of people and working to determine price, distribution, brand image, forecasting, and overall strategy for one or more drugs. On a micro level, the job can be claustrophobic: Imagine spending 13 months of six-day weeks learning every aspect of a single drug, then having the company decide that it would be best simply to let the product die. But over the years you should be exposed to some of the most important, dynamic, and profitable drug markets in the industry, an experience that will give you a big-picture understanding of the industry and make you a greater asset to the company.

Strategy Director
Strategy directors develop plans for maximizing the commercial potential of a particular product or therapeutic area. They perform quantitative and qualitative analyses of disease and treatments trends, as well as assess opportunities for expanding market share and competitive positioning. These individuals typically work closely with colleagues in marketing analytics, business development, and finance. An MBA or master's-level degree in a health care-related field is required, plus some industry experience.

Business Development Manager

Employees in business development evaluate new business opportunities aligned with a pharma company's therapeutic product divisions and strategic goals. They examine in- and out-licensing opportunities, collaborative development deals, and joint ventures. The position requires an MBA, strong analytical skills, and several years of industry experience. At some companies, PhDs work in this area as well.

Sales Jobs
Big Pharma companies maintain huge staffs of sales representatives, who work to keep physicians, hospitals, HMOs, and other medical institutions abreast of-and partial toward-their company's drugs. The act of selling to doctors is widely known as detailing, particularly if the salesperson uses company-produced visual aids.

Sales reps are categorized according to the particular customer base they serve: primary care physicians (PCPs), specialty physicians, hospital physicians, and managed care companies. Some sales reps visit pharmacies as well.

Field reps service territories that are typically defined by specialty and geography (for example all primary care doctors in Omaha, or all cardiologists in New Hampshire), and operate under a prescribed call cycle that determines how often they visit doctors in their territory. Call cycles range between two weeks and four months for most drugs, but can sometimes be as frequent as every few days during the introduction of hot new products or for physicians who prescribe in high-volume.

District managers usually are in charge of 10 to 14 field reps, hiring, training, and supervising them; regional managers oversee the district managers. Some sales positions require extensive travel; others don't. Virtually all positions come with generous perks such as a company car, computer, and expense account, plus attractive bonuses based on sales. A bachelor's degree in the sciences will help, and some type of previous sales experience is typically required. Many companies view sales as the natural entrée into marketing positions in the corporate office.

Average base salary for all sales reps: $68,600 plus generous incentives (specialty and hospital reps earn higher on average than PCP reps)

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