Continuous Learning and Development

Lacey M. Lee, Senior Medical Writer

Interview with Lacey M. Lee, Senior Medical Writer, Post-Approval Medical Writing
By: Lea Cosentino, Senior Recruiter

Interviewer: Can you provide a brief overview of the post-approval medical writing group at PPD?

Lacey: The post-approval medical writing (PAMW) group supports many types of deliverables for different clients. Examples of those deliverables include standard response documents, formulary dossiers, out-of-scope inquiries, manuscripts, continuing education materials, medical affairs studies, and risk evaluation and mitigation strategy program materials.

We handle communications related to drug and device therapies that are in the peri- and post-approval phase of development as well as life cycle support. Many of our deliverables are ultimately intended for health care provider and/or patient audiences.

Interviewer: Describe your background prior to joining PPD?

Lacey: I graduated from Campbell University College of Pharmacy and Health Sciences. I accepted a position at Duke University Medical Center (DUMC), and started as an inpatient clinical pharmacist, which is where I stayed for six years.

I transitioned to a newly created clinical pharmacist, medication stewardship position with responsibilities managing the health system pharmacy utilization management program, serving as a primary reviewer for the Duke University Health System Institutional Review Board (IRB) and serving as the study coordinator for the Department of Pharmacy Clinical Research Committee.

Once I reached 10 years in my career, I reassessed my interests. I found the opportunity posted at PPD and knew that was exactly what I was seeking.  

Interviewer: What does a typical day look like for a Sr. Medical Writer?

Lacey: I look at the number of projects I’m working on and prioritize according to timelines. I determine how much time I need to allot for each project. With PAMW being a global group, we work closely with other time zones and therefore often have developments overnight. I allow time in my day for client projects or things that may require fast turnaround. I attend client meetings and internal team meetings.

We have various global trainings offered throughout the month. These are recorded are stored online. PPD’s online corporate learning center offers a tremendous amount of training related to work environment, managing timelines/projects, and leadership and skills development. PPD’s system offers training related to multiple therapeutic areas, which are helpful when I need a refresher on disease state or treatment options applicable to the project.

My role is to assess things like data integrity and fair balance. We work closely with the document review group to schedule editorial/quality reviews of deliverables according to each client’s timeline needs. As a senior medical writer, I am responsible for assisting with and/or managing multiple projects simultaneously. We develop project timelines, track project work and liaise with other functional units such as biostatistics, regulatory affairs, epidemiology, pharmacovigilance and quality assurance.

Interviewer: How has your career developed since joining PPD?

Lacey: Since starting I have been given the opportunity to gain experience in the development and maintenance of post-approval medical letters and study procedural documents. In addition, I have worked on regulatory medical writing training to gain supplementary medical writing experience.

Interviewer: What do you enjoy the most about working for PPD?

Lacey: One aspect I enjoy most is the variety of work and the challenges it brings me. There are numerous challenges that medical writers encounter and learn from daily. The second thing would be the team work environment. For someone like myself, I have been welcomed and given mentors with extensive writing experience. They have helped me with my writing skills and other therapeutic areas. Everyone is very willing to sit down and talk to you and mentor you. In our Post-Approval MW group, we have an open discussion about who has bandwidth and who is over capacity. People volunteer to take the work, even when it might be with a new project they have never worked with previously. Those who have time are eager to help.

Interviewer: Finally, what advice would you give to someone looking to develop a career within Medical Writing?

Lacey: Clinical backgrounds and an understanding of drug/device development are relevant areas of knowledge for medical writing. It helps to know how the information you are generating is going to be used to inform patient care. Think about medical communications and obtaining call center experience, then transition over to medical writing. Look at another role within PPD in order to transition to the medical writing group. Any mass communications experience with the client is a good learning experience. Consider joining the American Medical Writers Association. I also recommend taking the certified medical writing exam.

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