Principal/sr.medical Writer (ctd/ctt & Redaction)
- Syneos Health
- 4 - 9 years
- India
- 24 days ago
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Job Description
JOB SUMMARY
Clinical Trial 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 4-8 years experience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management.
Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected.
JOB RESPONSIBILITIES
1. 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
2. Additional Activities
Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s)
QUALIFICATION REQUIREMENTS
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- 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)
- 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
Job Classification
Industry: Clinical Research / Contract ResearchFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Medical WriterEmployement Type: Full timeContact Details:
Company: Syneos HealthLocation(s): India
Keyskills: Health Canada PRCI Transparancy Redaction Disclosure EMA policy 0070 Anonymization CTT CTD FDA EUCTR Medical Writing
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