SyneosHealth is hiring Senior Medical Writer for Office/ Home Based

Sr Medical Writer (Clinical Trial Transparency)

SyneosHealth is hiring Senior Medical Writer for Office/ Home Based.

post title; Sr Medical Writer (Clinical Trial Transparency)

job location; Bangalore

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:

Syneos Health looking for a 4-8 years of experience medical writer who will be involved in the redactions/anonymization of clinical documents as part of the 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, and 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 a disclosure perspective. A 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 by the 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)

Qualifications

QUALIFICATION REQUIREMENTS

  • Educational qualifications: A minimum of a scientific graduate degree in life sciences.
  • Good knowledge of regulatory requirements or guidance pertaining 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.
  • A person should understand & comprehend protocol and clinical study report from a disclosure perspective.
  • Good understanding of clinical trial disclosure fundamental
  • Core competencies for this role include the 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

– Minimum 4 to 8 years experience in medical writing
– Experience in redactions/anonymization of clinical documents as part of preparation for different regulations.
– Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinical trials. gov and for various clinical registries.

Application process; Please apply on the below link or share your updated resume at geetika.suchal@syneoshealth.com

APPLY HERE

Sr Medical Writer (Clinical Trial Transparency)
SyneosHealth is hiring Senior Medical Writer for Office/ Home Based.

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