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Human Resources is just what it says: resources for humans – within the workplace! Its main objective is to meet the organizational needs of the company it represents and the needs of the people hired by that company. In short, it is the hub of the organization serving as a liaison between all concerned. Depending on the size of the company, the HR Department might be called Personne

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

l with a manageable workforce that can be handled by a personnel manager and a small staff. For larger, more complex organizations with hundreds of departments and divisions, the task is much more demanding, taking on a life of its own.

Some companies have more than one HR Department - Corporate and Union. For example, a food service industry might have a Corporate HR Department tha

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t oversees “white collared” employees and an HR Department that oversees the “blue collar” workforce with an emphasis on labor relations. With such diverse needs, the organization will institute these two HR Departments to manage the unique needs of both union and non-union employees. Some of the many core functions of the Human Resources function involves the following: Organization

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

al Development: To ensure its success, a company must establish a hierarchal reporting system. Picture an organizational chart with boxes representing each position starting at the top with the first and single-most important being the highest-ranking role. Following the lines, more boxes are branched off to define each department head and their direct reports. As the company expands

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

so will this chart. The funnel of responsibility is critical to the efficiency of a smoothly operating business entity in which there is a clearly defined understanding of who is responsible for what. This is what HR does for a company. They provide consultation to a company’s management team to identify what the company’s core business and culture is about, and proceeds to plan and

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

map the company’s organizational infrastructure to support those needs.

Employee Recruitment and Selection Process:

There are many steps to recruiting and selecting qualified employees. First, a department head must inform the HR manager of an opening in their department. Then the HR manager must obtain the job description to formulate a Job Description Sheet for publication eithe

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

r internally, publicly, or both. Then HR must field the (many) responses to that job announcement to weed out the qualified from the unqualified applicants. Once that is completed, the interview process must be coordinated. This is a full time job! If one job ad generates 80 responses, there’s a good chance that only 10 applicants are highly qualified for the position. If the departm

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

nt’s hiring manager were to interview the other 70 less-than-qualified applicants, their department would come to a complete standstill because there would be no time for anything else! That’s where HR, a.k.a. Fort Knox, comes in. They prepare the job description, contact the newspaper, run the ad, field the calls, faxes, and emails, compile a list of potential candidates from dozens

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

of in-coming resumes, submit their list of potential candidates to the department’s hiring manager for approval and selection, contact the chosen candidates to set up preliminary interviews, and interview the candidates! Yes, that’s right. Preliminary interviews! Although most interviews are with the hiring manager or their associates, not all applicants get to meet with the departm

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ent’s hiring manager right away. It is not uncommon for a company to filter out those who fail to impress the HR manager first. For those select few who make it through, the HR manager schedules interviews between the department’s hiring manager and potential candidates, and follows up with the hiring process to establish the new hire with the company. Not unlike the screening proces

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

for American Idol, a job seeker needs to perform their best to impress the “judges.” Employee Training & Development: As a company and the requirements of a position evolve, a company needs to take certain measures to ensure a highly skilled workforce is in place. The Human Resources Department oversees the skills development of company’s workforce, acting as an in-house training ce

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

nter to coordinate training programs either on-site, off-site, or in the field. This might include on-going company training, outside training seminars, or even college, in which case an employee will receive tuition reimbursement upon earning a passing grade.

Employee Compensation Benefits:

This covers salaries, bonuses, vacation pay, sick leave pay, Workers’ Compensation, and ins

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

urance policies such as medical, dental, life, and 401k. The Human Resources Department is responsible for developing and administering a benefits compensation system that serves as an incentive to ensure the recruitment and retainment of top talent that will stay on with the company. When an employee is hired, the company’s Benefits Coordinator is required to meet with employees one

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

-on-one or in small group settings to explain their benefits package. This often requires an employee to make an informed decision and to provide their signature for processing purposes

Employee Relations:

With the increased rise in unethical practices and misbehaviors taking place in today’s workplace such as age, gender, race, and religion discrimination and sexual harassment, th

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

re needs to be mandatory compliance with governing rules and regulations to ensure fair treatment of employees. In short, employees need to know they have a place to turn when a supervisor abuses his or her authority in anyway. Whether corporate or union, the HR Department will get involved to act as arbitrator and liaison between legal entities, regulatory agencies such as Human Rig

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

hts, supervisors (who might be falsely accused), and employees to properly address and resolve the issue at hand.

Policy Formulation:

Regardless of the organization’s size, company policies and procedures must be established to ensure order in the workplace. These policies and procedures are put in place to provide each employee with an understanding of what is expected of them. Si

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

milarly, these policies and procedural guidelines will assist hiring managers in evaluating their employee’s performance. These policies can be established company-wide or used to define each department’s function. It is Human Resource’s responsibility to collaborate with department managers on the formulation of these policies and regulations to ensure a cohesive organization. A com

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

on practice is the development and implementation of an Employee Procedure Manual or Employee Handbook that is either distributed to each employee at the time of hire or a master copy allocated one to a department.

HRIS – Human Resources Information Systems:

To keep track of the vast amount of data, a human resources department must have a good HRIS in place to automate many functi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ons such as planning and tracking costs, monitoring and evaluating productivity levels, and the storing and processing of employee records such as payroll, benefits, and personnel files.

It is very important that you, the job seeker, understand how the HR function works – specifically in the area of candidate recruitment. If you are considering a career in human resources, you can c

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

hoose to become a Generalist or a Specialist. Some titles include HR Manager, HR Recruiter, HR Administrator, Payroll Coordinator or Assistant, PeopleSoft HR Project Manager, Benefits Administrator or Coordinator, Labor Relations, Training Coordinator, HRIS Specialist and HR Consultant.

Whether a job seeker or a HR professional, research a company well before applying for a position

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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