Description
NextLink are currently working with a leading pharmaceutical organisation who are seeking a Medical Writer on an initial 6-month contract on a remote basis.
The Role:
- Manages the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Works closely with the study team writers to ensure timelines and deliverables are met
- Completes document reviews according to agreed-upon timelines and follows up with the study team writers as needed to meet internal and external timeline commitments and procedural and regulatory requirements
- Updates project-related tracking tools
- Maintains records for all assigned projects, including archiving
- Schedules and conducts document-related meetings, including the preparation of meeting agendas, key data points for discussion, and meeting minutes
- Works closely with the study team to ensure that content and results in clinical documents are accurate and compliant.
Must Have Skills:
- Science Degree with Research Experience (3-5 years of experience - emphasis on Medical Devices)
- Experience of Clinical Evaluation Reports
- Manages the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
- Works closely with the study team writers to ensure timelines and deliverables are met
- Completes document reviews according to agreed-upon timelines and follows up with the study team writers as needed to meet internal and external timeline commitments and procedural and regulatory requirements
- Updates project-related tracking tools
- Maintains records for all assigned projects, including archiving
- Schedules and conducts document-related meetings, including the preparation of meeting agendas, key data points for discussion, and meeting minutes
- Works closely with the study team to ensure that content and results in clinical documents are accurate and compliant.