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PPD

Senior Med Writer/ Principal Med Writer (remote)

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 teams.   

 

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 insight. 

 

As a Senior regulatory medical writer, you will be in a lead position that offers working with key clients and continued career growth opportunities.   

 

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 preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
 
Knowledge, Skills and Abilities:
Must possess the ability to manage large projects with minimal supervision
Must possess the ability to coordinate production of deliverables and provide leadership to a project team
Must possess independence in decision making and problem solving
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 or activities.
May require travel.  (Recruiter will provide more details).

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