The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs. More than anything else, our story would be about people. Not only our over 11,000 employees operating in more than 80 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.
Post: Medical Writer
Job Description
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
Candidate Profile
- 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
Additional Information:
Qualification: Any
Location: US
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Medical Writer
End Date: 20th August, 2016
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