1. Authoring and Quality Assurance of Project Activities
- Undertakes project specific activities at high quality and in defined timelines according to standard processes and operating procedures
- Authoring and/or editing of pertinent documents such as:
- Clinical study documents or documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc.
- External scientific communications i.e. manuscripts, abstracts, response documents, etc.
- Protocol and results summaries to support clinical trial disclosure commitments
- Systematically perform quality control checks of documents prepared by colleagues against pre-specified check-list 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
- Medical writer who will be preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various clinical registries
2. Additional Activities
Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s)
What we’re looking for
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- Require minimum 1 year of experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and various other clinical registries.
- Good knowledge of regulatory requirements or guidance pertinent to the service line.
- Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills
- Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
- Person should understand & comprehend protocol and clinical study report from disclosure perspective.
- Good understanding of clinical trial disclosure fundamental
- Core competencies for this role include ability to demonstrate:
- Analytical capabilities with scientific and clinical data.
- Professional working environment
- Ownership of the work allocated
- Commitment to highest quality outputs, including high attention to detail
- Enthusiasm and pro-activity
- Effective team working
- Ability to build rapport/ relationships with project-specific client colleague
Apply : https://www.syneoshealth.com/clinical-corporate-careers/jobs/12080215-medical-writer-i-clinical-trial-transparency
Leave a comment