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 Apply tot his job Apply To this Job