Senior regulatory writer
The Duke Clinical Research Institute (DCRI) Regulatory Writing group has an opening for a Senior Medical Writer with regulatory writing experience.
The position is full time permanent, and is located in the DCRI offices in downtown Durham, North Carolina, although remote work is a possibility.
The Senior Medical Writer will be responsible for planning, writing, and editing submission documents across multiple therapeutic areas and in compliance with ICH, FDA, and global regulatory guidelines and requirements. Assignments will include acting as coordinator and lead writer in the compilation and writing of clinical study reports, summary sections of regulatory submissions, protocols and investigators' brochures for investigational drugs, devices, biologics and/or combination products.
Other work will include, but not be limited to, the following:
*Confer with Sponsor representatives, DCRI Faculty/Coordinating Investigators, Statisticians and Project Leaders to plan document content, timelines, and communication lines for the review/revision process
*Coordinate and facilitate review of assigned documents, and consolidate reviewer comments to create appropriate revisions
*Serve as an expert resource on the content and format of various submission documents
*Confer with members of the DCRI project team, including the Project Leader, Lead Statistician, Lead Safety Associate and Clinical Data Management Associate, to compile necessary document content and appendices
The Senior Medical Writer requires knowledge of the structure and purpose of a variety of submission documents; the ability to comprehend and describe in writing concepts of medical/clinical science across multiple therapeutic areas; and knowledge of relevant guidance for documentation of investigational drugs, medical devices, biologics and combination products. This employee will assist with maintenance of templates for study reports, protocols, and other submission documents, for reference by internal and external clients.
Minimum Qualifications are a Master's degree in a medical or life science, medical or technical writing, or other related field (Advanced degree preferred-MD, PharmD, PhD); and 5+ years of relevant medical writing experience in pharmaceutical, biotechnology, or other clinical research environment; or an equivalent combination of relevant education and/or experience
The successful candidate will require the following knowledge, skills and abilities:
- Excellent comprehension of clinical/scientific literature, medical terminology and statistical methods
- Excellent ability to interpret and describe statistical data in written reports
- Ability to efficiently search, evaluate, and summarize clinical literature
- Excellent attention to detail
- Excellent written and verbal skills
- Familiarity with the contents and purposes of regulatory submission documents, including clinical study reports
- General familiarity with clinical research processes and regulations governing clinical research globally
- Intermediate to advanced knowledge of Microsoft Word, and familiarity with Adobe Acrobat, Microsoft Excel, and citation management systems such as EndNote and Zotero
- Ability to provide job-specific training to other Medical Writers
- Ability to work independently and to perform equally well as part of a team
- Able to balance multiple activities in a complex environment and to meet critical deadlines
- Strong interpersonal skills to develop and maintain positive working relationships with internal and external clients
To apply and to see the full position description, please see: Senior Regulatory Writer, Duke Clinical Research Institute. The position can also be found by going to https://hr.duke.edu/careers/apply, and entering Requisition number 401149438.