Syneos Health Hiring for Medical Writer (Clinical Trial Disclosure)

Syneos Health Hiring for Medical Writer (Clinical Trial Disclosure)

27 May, 2022

JOB SUMMARY

He/she works as part of high-performing teams on challenging assignments involving the processing of complex scientific, medical and technical information.

JOB RESPONSIBILITIES

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 procedure.
  • Authoring and/or editing of pertinent documents such as:

o 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).

QUALIFICATION REQUIREMENTS

· Educational qualifications: Life science graduate/ post graduate with 1+ year of experience in Clinical Trial Data Disclosure.

· Must have good knowledge of Data Anonymization/ Redaction, Registries (EUDRACT, CT.GOV)

· 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 through this Link

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