Medical Writer
2 days ago
JOB SUMMARY:
Clinical Trial Transparency/Disclosure plays a critically important role in executing projects for Syneos global clients. He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical and technical information.
Skills:
We are looking for 1-4 year experience medical writer who will be preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for and for various clinical registries. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of clinical trial disclosure fundamentals.
JOB RESPONSIBILITIES
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 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)
Preferred candidate profile
- candidates having experience in Clinical Trial Disclosure or CTT experience.
- Should have protocol registration, result registration experience
- Preferred experience with results posting for regulatory bodies such as US FDA, ),
- Redaction exp will be added advantage
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