Full Job Description
Job Locations (All) | US-Remote
Posted Date 2 days ago(6/30/2020 8:36 AM)
Applies a wide range of therapeutic expertise and clinical drug development knowledge to the development of drugs, biologics, devices and/or other products for human use in developing individual clinical study protocols, clinical plan outlines, drug development programs, clinical study reports, manuscripts, investigator brochures, and sections of regulatory submission documents. Also provides therapeutic training to external clients and internal PRA staff.
Contributes advanced therapeutic expertise, clinical drug development knowledge/skills, and scientific/technical expertise in the development of clinical plan outlines and design of clinical drug development programs for the development of drugs for human use
Consults with and advises other medical writers and clients in the development of clinical plan outlines and design of clinical drug development programs
Develops clinical study design documents and clinical protocols
Builds and maintains strategic relations with customers
Provides client support regarding clinical data and issues at regulatory meetings
Directs and/or leads the writing, reviewing and editing of various technical documents
Evaluates non-clinical and clinical data in the development of technical documents such as regulatory submission documents, (e.g. meeting packages, investigational new drug [INDs] applications, and sections of marketing applications [NDA/MAA/CTD] or other submissions depending on host country), clinical study reports, investigator brochures, pharmacovigilance documents, poster presentations and manuscripts
Directs or performs scientific literature searches for manuscript writing and to support sections of deliverables including regulatory submissions
Provides bid estimates for medical writing work for potential projects and attends bid defense when requested
Leads project teams that involve protocol development and preparation of regulatory information packages
Serves as project team leader overseeing operational activities of other medical writers
Develops and implements training for medical writers and mentors junior staff members
Conducts in-service training for clinical research associates, other clinical functions and clients in area(s) of therapeutic expertise
Mentors all levels of medical writing personnel
Develops and implements training for all medical writers
Substantial experience in pharmaceutical or CRO industry developing pharmaceutical drugs for human use required e.g. non-clinical science, medical related writing, protocol writing, writing for regulatory submissions, clinical trials management, monitoring, or as an investigator or sub-investigator for clinical trials
Substantial experience writing clinical study reports, other regulatory submission documents, poster presentations, and manuscripts for publication in a scientific journal required
Experience using computerized systems (PC-Windows, and MS Office) required
Knowledge of regulatory agency requirements for protocols and regulatory submissions in the host country required
Direct or indirect experience interacting with FDA or host country regulatory agency required
Demonstrated project leadership skills required
Read, write and speak English; fluent in host country language required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Apply for this job onlineApply
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed
Connect With Us!