Syneos Health Medical Writer I (Clinical Trial Transparency /Redaction) job vacancy | Apply Now

Medical Writer I (Clinical Trial Transparency /Redaction)

Medical Writer I

Location: India-Asia Pacific – IND-Home-Based, India

Job responsibilities:

Works cross-functionally and collaboratively to plan and coordinate the global transparency activities (Marking 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) and to ensure/support compliance with procedures and to manage external communication.
Ensuring that are compliant with all applicable policies, procedures, and regulations
Undertakes project specific activities at high quality and in defined timelines according to standard processes and operating procedures.
Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP
Maintain accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking.
Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs
Ensure to abide with Client process.
Completion of Internal and Client specific training

Qualifications

What we’re looking for

Educational qualifications: A minimum of a scientific graduate degree in life sciences.
We are looking for 6 months – 1 year experience in medical writing.

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
– Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel/Adobe, 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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