Executive Administrative Assistant Job Description Pharmaceutical

Current job title: Executive Administrative Assistant

Industry: Pharmaceutical

Department: Regulatory Affairs

Years worked in this industry: More than 7

Years worked in this department: More than 2

Special training or attributes needed or helpful to get job in this industry (or specific department): The healthcare/pharma business is somewhat “incestuous” in the fact that when you move to another company within the industry, there is bound to be others working there that worked at a previous employer of yours. The individual that was bringing in people to interview worked at my previous employer. This helped get me in the door.

Number of managers and/or staff supported: One VP, four Directors, three Associate Directors, seven Managers, and 15 staff members

Typical work hours: 9am – 5:30pm

Weekends or overtime hours: Yes, I put in extra time during the weekends and evenings – utilizing a laptop so that I can work in the comfort of my home. On average I work 5-10 extra hrs weekly and get paid time and a half, plus double-time on Sundays and Holidays.

General salary range (Note: This is a general figure or range provided by survey respondent and may NOT be an exact salary in order to give survey respondent some privacy. Also you must take into account that the number of years worked in industry/department may contribute to this salary as well as criteria such as level of position and person reports to, required hours and geographical location.): approx. $21 per hour

Benefits (direct or indirect): My benefits are comparable. My medical/dental is better than my husband’s. Bonus structure is O.K. (5-8% of base depending on individual and company performance). Great 401K plan with matching. Deals (nationally and regionally) with vendors/service providers for discounts (that’s a nice touch). 3 weeks paid vacation (new employees receive only 2 wks) + 3 personal days + 8 Holidays during 2006. Sick days for non-exempt are only paid out at 66.66% (with a max of 10 days – then payout drops significantly).

Lingo you might hear in this industry:

 510(k) – A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device. Each person who wants to market Class I, II and some III devices intended for human use in the U.S. must submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. There is no 510(k) form but instead a format for the submission described in 21 CFR 807 and in the pages that follow.

 CFR – Code of Federal Regulations; The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis. The online CFR is a joint project authorized by the publisher, the National Archives and Records Administration's (NARA) Office of the Federal Register (OFR), and the Government Printing Office (GPO) to provide the public with enhanced access to Government information.

 Small Volume Parenteral - Pharmaceutical companies are manufacturers of both solid and liquid formulations. Solid formulations may be tablets, dry powders, confectionary and solid injectables; liquid formulations may be eye drops, ointments, I.V. and other parenteral solutions. Parenteral solutions are packed as large volume parenteral (LVP) solutions, small volume parenteral (SVP) solutions and dry powders requiring reconstitution as either LVP or SVP. Small volume parenteral (SVP) solutions are usually 100 ml or less and are packaged depending on the intended use. SVPs are typically packed as ampoules, vials, small bags and prefilled syringes. If the solution is a sterile formulation it must be free of all visible particulate material. Particulate material refers to mobile, solids unintentionally present in parenteral products. These solids may consist of individual components or mixtures of cellulose, glass, rubber cores from vials, metal and plastic fragments. Sterile suspensions may have particulate material, but these are usually the active drug or an ingredient, not contaminants. Potential sources of particulate contamination:
 Manufacturing environment and equipment
 Manufacturing personnel
 The packaging components

A typical day on the job: Doesn’t exist. Each day is completely different from the next. Daily, I go through approx 80-90 emails, fax/copy/scan docs, manage the VP’s calendar.

Positive things about being an administrative professional in this industry:

1. The company is a global specialty pharmaceutical and medication delivery company dedicated to advancing wellness by developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care.

2. I enjoy making a difference in the world; helping people feel better and stay healthy.

Negative things about being an administrative professional in this industry:

Telephone coverage. Since we work with the government on a daily basis, we make sure that the telephones in our dept are covered between 7am and 5:30pm. Since there are only two admins, this can be difficult sometimes during vacations, sick days, etc. We try to always think ahead regarding backup so that we are covered.

Type of workspace/office: cubicle

Primary responsibilities as an administrative professional in this position:

The primary responsibilities of the admin team is as follows:

1. Telephone coverage

2. Processing of correspondence from regulatory agencies (FDA, Health Canada, etc.)

3. Support of the VP and his direct reports (7 people) (calendar mgmt, travel, projects, etc.).

Top thing(s) incumbent admin would require of job applicants seeking to be her/his position replacement: The top four things are:

1. Make travel arrangements. Complete expense reports from source documents, assuring necessary documentation is available and appropriate account numbers are used. May be required to make international travel arrangements.

2. Establish priorities to handle competing demands within a timely manner. Identify and secure resources and monitor progress to ensure that task/project deadlines are met and results achieved. Obtain feedback on results. Clarify to ensure that the message is being accurately understood.

3. Use standard computer applications to compile data, accomplish assignments, tasks and projects. Break work into process steps and establish follow-up procedures.

4. Maintain departmental supplies, ordering as necessary. Follow company purchase and requisition procedures.

Office machines or equipment operated regularly: Fax, computer, printer, scanner, copier, labelmaker

Technology (hard) skills used regularly:

 Outlook
 Visio
 PowerPoint, Word and Excel
 MS Project
 Research via the Internet

Critical soft skills:

 Organizational Skills (otherwise things will fall through the cracks)
 Attention to Details
 Oral and Written Communication Skills
 Software Skills – including presentation skills
 Time Management skills

Pace of this position: fast

Geographical region: Midwest U.S.