Senior Medical Writer, Redaction – Clinical Trial Transparency

Remote Full-time
Job Description:
• Authoring and Quality Assurance of Project Activities
• Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures
• Marking /QC/Review and/or editing of pertinent documents such as Clinical study documents for regulatory submission
• Protocol and results summaries to support clinical trial disclosure commitments
• Systematically perform quality control checks of documents prepared by colleagues against checklist
• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
• Completion of Internal and Client specific training
• Assist in mentoring and training of team members

Requirements:
• Authoring and Quality Assurance of Project Activities
• Execute project specific activities with high quality and in defined timelines according to standard processes and operating procedures
• Marking /QC/Review and/or editing of pertinent documents such as Clinical study documents or any other documents for regulatory submission
• Protocol and results summaries to support clinical trial disclosure commitments
• Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP
• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
• Completion of Internal and Client specific training
• Assist in mentoring and training of team members depending upon project requirement(s)

Benefits:
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time

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