Senior Medical Writer, Redaction – Clinical Trial Transparency
- 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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