$130K — $140K
Medical Clinical Writer needs 2+ years of clinical research experience; Bachelor’s degree (preferably in Biological Sciences or English)
Medical Clinical Writer requires:
• Knowledge of drug development lifecycle and familiarity with clinical documents
• Demonstrated ability to manage timelines and execute to due date
• Excellent organizational skills, attention to detail, and strong oral and written communications skills
· Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).
Medical Clinical Writer duties:
• Assist with writing and execution of clinical drug trial registrations on trial registries (e.g. Clinicaltrials.gov) per the applicable regulatory and SOP requirements.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of Trial Disclosure (TD): to effectively communicate information and related timelines to the applicable individuals involved in registration activities, to provide guidance and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information (including populating each Protocol Record with disclosure information on Clinical Trials.gov).
• Maintain/track TD for clinical drug trials, including the documentation and storage of the information.
• Cross-train with other TD staff.
Valid through: 4/19/2021