Job Summary:
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial Master File, including remediation
Principal Accountabilities:
• Assist Medical Writing Operations staff with document approval and notification processes and maintenance of the Trial Master File, including submission of documents and routine QC and remediation. 90%
• Assist Medical Writing staff with document formatting/troubleshooting/reference management. 10%
• Impacts quality of clinical documentation. Liaises with staff across Development Sciences and Global Medical.
Knowledge & Skills:
• Advanced Microsoft Office skills (Word, PowerPoint, Excel); familiarity with Adobe, Documentum, other systems as needed.
• Strong attention to detail.
• Ability to multitask in a fast-paced environment.
• Excellent oral and written communication skills.
• Aptitude for learning new systems and technology.
• Familiarity with the clinical development process, understanding of trial master file.
Minimum Education Requirements: Associate’s Degree required; Bachelor’s Degree preferred.
Minimum Experience Requirements: 1+ year experience in biotech or pharmaceutical company (R&D, Clinical preferred).
With Regards,
Kavita Kumari
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 – 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Tel: 732-549-2030 x208
Fax: 732-549-5549
Direct: 732-549-5302
www.irionline.com
https://www.linkedin.com/in/rkavita
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.