C HOOSING THE R IGHT R EGUL ATORY C AREER
who needs assistance with his or her job, even if it means staying late or coming
in early. For example, if you notice that regulatory operations is preparing a
big submission, ask whether there is anything you can do to help, even if
operations is not your job or you have never done it before. Often, you can
check links and bookmarks or perform a quality check on documents and, in
the process, learn about putting together a submission and how FDA might
navigate that submission. You might also volunteer for special projects you
have the skills or ability to complete so you can gain additional experience or
build better relationships.
For example, about 15 years ago, I volunteered to build a major database
that would be used by the entire company to track a certain type of document,
actions required, responsibilities, responses and other key items. It took about
three weeks to build the comprehensive database and teach several users how
to input information into the system. The database was in use for about 10
years and the heads of the impacted units never forgot I had stepped in and
volunteered to give them a tool to make their jobs easier and made them more
effcient. To this day, I can call those individuals for information or advice and
they occasionally still refer to how that database helped them.
Another aspect of this advice is to always try to do the work of the next
position you want. When an opportunity arises that will allow you to take on
more responsibility within your own department, even if it is only temporary,
take it—every small step will lead you closer to the position you want. During
my own career, I often boldly requested more responsibility and opportunity
and was frequently rewarded for taking the chance, including getting more
responsibility, gaining additional learning and experience outside my specifc job
function and, ultimately, receiving promotions or being sought after for highly
visible projects. The worst that could happen is for someone to say you are not
quite ready or they have chosen someone else this time.
For example, I worked for a company whose projects were led by PhD
professionals. When there were too many projects for the available PhD project
leaders, the company had to decide whether to postpone a project, give too
many projects to a single leader or hire another project leader who would then
have too few projects. Recognizing this dilemma, I went to the president of the
company and said that I wanted the opportunity to lead the project. I told him
why this would be a good choice what experience, skills and abilities I brought
to the table what I was willing to do to get the job done and what I would do to
get mentoring in the areas where I did not have enough information or needed
some guidance. In view of my self-confdence and the plan I presented, I became
the frst non-PhD project leader for the company. I still had to fulfll all my
4
who needs assistance with his or her job, even if it means staying late or coming
in early. For example, if you notice that regulatory operations is preparing a
big submission, ask whether there is anything you can do to help, even if
operations is not your job or you have never done it before. Often, you can
check links and bookmarks or perform a quality check on documents and, in
the process, learn about putting together a submission and how FDA might
navigate that submission. You might also volunteer for special projects you
have the skills or ability to complete so you can gain additional experience or
build better relationships.
For example, about 15 years ago, I volunteered to build a major database
that would be used by the entire company to track a certain type of document,
actions required, responsibilities, responses and other key items. It took about
three weeks to build the comprehensive database and teach several users how
to input information into the system. The database was in use for about 10
years and the heads of the impacted units never forgot I had stepped in and
volunteered to give them a tool to make their jobs easier and made them more
effcient. To this day, I can call those individuals for information or advice and
they occasionally still refer to how that database helped them.
Another aspect of this advice is to always try to do the work of the next
position you want. When an opportunity arises that will allow you to take on
more responsibility within your own department, even if it is only temporary,
take it—every small step will lead you closer to the position you want. During
my own career, I often boldly requested more responsibility and opportunity
and was frequently rewarded for taking the chance, including getting more
responsibility, gaining additional learning and experience outside my specifc job
function and, ultimately, receiving promotions or being sought after for highly
visible projects. The worst that could happen is for someone to say you are not
quite ready or they have chosen someone else this time.
For example, I worked for a company whose projects were led by PhD
professionals. When there were too many projects for the available PhD project
leaders, the company had to decide whether to postpone a project, give too
many projects to a single leader or hire another project leader who would then
have too few projects. Recognizing this dilemma, I went to the president of the
company and said that I wanted the opportunity to lead the project. I told him
why this would be a good choice what experience, skills and abilities I brought
to the table what I was willing to do to get the job done and what I would do to
get mentoring in the areas where I did not have enough information or needed
some guidance. In view of my self-confdence and the plan I presented, I became
the frst non-PhD project leader for the company. I still had to fulfll all my
4