Principal Medical Writer (CTT) Syneos Health

8.0 - 13.0 years

8 - 16 Lacs

Pune

Remote

Role & 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, ,National registries (DIMDI)) CTT Data base experience ( Disclose, Prime, PRS, EudraCT) Protocol and results summaries to support clinical trial disclosure commitments S...

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Sr Medical Writer (Redaction) Syneos Health

5.0 - 10.0 years

8 - 16 Lacs

Pune

Remote

Role & 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...

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Medical Writer (CTT) Syneos Health

3.0 - 5.0 years

5 - 13 Lacs

Pune

Remote

Role & responsibilities: • Mentors less experienced medical writers on projects, as necessary. • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. • Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. • Interacts with department head and staff members in data management, biost...

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