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.
