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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 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

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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 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 Preferred candidate profile: Experience in redactions/anonymization of clinical documents as part of preparation for different regulations. Well versed with Health Canada /EMA policy.

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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, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. • Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. • Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. • Performs on-line clinical literature searches, as applicable. • Working knowledge of drug development process and regulatory guidelines. • Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. • Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. • Completes required administrated tasks within the specified timeframes. • Performs other work-related duties as assigned.

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