Sop Writer

Medical Affairs Writer JD1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards.2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan.3....

Medical Affairs Writer JD1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3....

Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3....

Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3....

Medical Affairs Writer JD1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards.2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan.3....

Job Description Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical...

Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3....

Job Overview Acts as Lead Medical Writer on more advanced writing projects (e.g. complex clinical study reports, protocols, more challenging indications, or customers). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. May provide feedback to peers when...

Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. - Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document. - Perform QC review of documents (Data...

Company Description Ergomed is a rapidly expanding full service mid-sized CRO specializing in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility (you have...