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 or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) • 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 • Ensure to abide with Client process Requirements: • 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 or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) • 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 • Ensure to abide with Client process • 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