PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life
saved. All in-between, it’s you! We know that meaningful results not only require the
right approach, but also the right people. We invite you to re-imagine health promoting
protocols with us, working alongside our talented, bright and energetic
We are passionate about being data and technically agile and driving enhanced value for our
clients and patients. Determined to improve patient health, we help PPD provide
industry-leading statistical, programming and clinical pharmacology contributions through
global delivery, consistent quality adherence and scientific
As a Senior regulatory medical writer, you will be in
position that offers working with key clients and continued
At PPD we hire the best, develop ourselves and each other, and recognize the power of being
one team. We offer continued career advancement opportunities, award winning training and
benefits focused on the health and wellbeing of our employees.
What does this role entail?
Serves as primary author who writes and provides input on routine documents such as clinical
study reports and study protocols, and summarizes data from clinical studies.
Since this is Regulatory writing role, you will research, write, edit complex
clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Reviews routine documents prepared by junior team members. May provide training and mentorship
for junior writers and program managers on document preparation, the use of software for document
development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. Provides input
on and independently develops best practices, methods and techniques for achieving optimal
results, including various client-specific processes.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and
relevant formal academic / vocational qualification; Advanced degree
Previous experience that provides the knowledge, skills, and
abilities to perform the job (comparable to 5 years).
Experience working in the pharmaceutical/CRO industry
Additional qualifications in medical writing (AMWA; EMWA;
Knowledge, Skills and Abilities:
Must possess the ability to manage large projects with minimal
Must possess the ability to coordinate production of deliverables
and provide leadership to a project team
Must possess independence in decision making and problem
Must demonstrate an ability to serve as a departmental resource for
training, mentoring, and the development of process improvements for Medical Writing
Must possess all requisite skills of the Medical Writer position,
including excellent grammatical, editorial, and proofreading skills, and the ability to
interpret and present extremely complex data
PPD is an inclusive equal employment opportunity
company. We value all people regardless of background, experience and abilities.
PPD values the health and well-being of our employees. We support and encourage individuals to
create a healthy and balanced environment where they can thrive. Below is listed the
working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of
people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects
May require travel. (Recruiter will provide more details).