Senior Medical Writer (CTT & redaction)

Syneos Health

4 - 8 years

14 - 15 Lacs

gurugram

Posted:1 day ago| Platform:

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Skills Required

career development manager quality assurance analytical agile clinical development life sciences http manager quality control recruitment clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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