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, etc
Job tags
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