Biotech Healthcare
Location
Ahmedabad | India
Job description
Role Objective To set up and lead in-house medical writing capability; setting standards, creating processes and building & and coaching a team, that can develop clinical study documents as per ISO 14155, MDR and ICH GCP.
Role & Responsibilities: Medical Writing as per ISO 14155, MDR and ICH GCP Coordinating with the internal team for the study design. Literature search based on the study design. Design the protocol synopsis based on the inputs of the Medical/Technical experts. Draft the Protocol based on the Inputs received from Medical/Technical Experts. Design the ICF (Informed Consent Form) and CRF (Case report form) based on the final Protocol. Manage overall writing workflow, identifying projects to be completed in-house or to be outsourced, while making sure all are delivered on time. Review of Manuscript and Poster. Review of Clinical Study Report. Update SOPs related to Medical Writing from time to time. Analyze the customer survey & and feedback. Quality and Regulatory Support as per ISO 14155, MDR and ICH GCP Support Ethics Committee in preparation, submission and coordination of Regulatory dossier for Clinical trials of different countries. Support application for protocol amendment(s). Update Regulatory agencies about additional sites & and notifications. Support Ethics Committee and Regulatory Agency in SAE reporting. Maintain Quality Management System for PMS and Clinical trials as per ISO 13485. Represent the Clinical affairs department in ISO and CE Audits. Perform other related duties as assigned. Desired Candidate Profile: Medical Writing and Scientific Writing (minimum 8 years experience). Sound knowledge of ISO 14155, MDR and ICH GCP. Experience in preparation & submission of dossiers for Ethics Committee & Regulatory agencies (Min. 2 Years of experience). Sound subject knowledge. Excellent English Communication (Written and verbal). Critical Skills Required: Medical Writing Regulatory Writing Clinical Trial Writing Scientific Writing Protocol Writing Case Study Report State Analytical Report Biotech is an Equal Opportunity organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etcJob tags
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