Description

Lead Medical Writer -Regulatory Medical Writing Location: Chandigarh (Hybrid) OR for outstation candidates WFH Salary Range : 30 LPA Experience Range: At least 6 years of experience in Regulatory Medical Writing and must have exposure to EU and US markets. Job Overview : Authoring and coordinating end-to-end process for preparation, review, approval and distribution of clinical regulatory documents, including Protocols, Investigational New Drug (IND) Application, Clinical Trial Application (CTA), Clinical Study Reports (CSRs), New Drug Application (NDA) and Clinical Summaries associated with the assigned products in accordance with worldwide regulatory requirements. Provides basic-level oversight and guidance for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. Functional Responsibilities : Responsible for any or all of the following activities: Leading the medical writing team for the design, planning, and preparation of high-quality clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules) Preparing regulatory clinical documents including Informed Consent Form (ICF), Investigators Brochure (IB), Protocols, Protocol amendments, etc. Co-ordinating between multiple verticals/functions for effective collection of information required for creation of Protocols and CSRs To independently manage and author high quality CSRs and its narratives, ICF, IB, Protocols, Protocol amendments, CTD modules, etc. Contributing to planning and streamlining process for data analysis, interpretation and presentation Ensuring presentation of analysed data in a clear, complete, accurate, and concise demeanour Overseeing the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Preparation and self-reviewing of various disclosure documents including Protocol Registration form, Results Registration form, Protocol amendments & updates, CSR synopsis, etc.

Role and Responsibilities

• Lead Medical Writer -Regulatory Medical Writing Location: Chandigarh (Hybrid) OR for outstation candidates WFH Salary Range : 30 LPA Experience Range: At least 6 years of experience in Regulatory Medical Writing and must have exposure to EU and US markets. Job Overview : Authoring and coordinating end-to-end process for preparation, review, approval and distribution of clinical regulatory documents, including Protocols, Investigational New Drug (IND) Application, Clinical Trial Application (CTA), Clinical Study Reports (CSRs), New Drug Application (NDA) and Clinical Summaries associated with the assigned products in accordance with worldwide regulatory requirements. Provides basic-level oversight and guidance for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations. Functional Responsibilities : Responsible for any or all of the following activities: Leading the medical writing team for the design, planning, and preparation of high-quality clinical documentation in support of clinical development, trials (e.g., pivotal CSRs), and filings (e.g., clinical modules) Preparing regulatory clinical documents including Informed Consent Form (ICF), Investigators Brochure (IB), Protocols, Protocol amendments, etc. Co-ordinating between multiple verticals/functions for effective collection of information required for creation of Protocols and CSRs To independently manage and author high quality CSRs and its narratives, ICF, IB, Protocols, Protocol amendments, CTD modules, etc. Contributing to planning and streamlining process for data analysis, interpretation and presentation Ensuring presentation of analysed data in a clear, complete, accurate, and concise demeanour Overseeing the work of other medical writers, providing scientific and operational mentorship and coaching in the design, planning, and execution of their assignments. Preparation and self-reviewing of various disclosure documents including Protocol Registration form, Results Registration form, Protocol amendments & updates, CSR synopsis, etc.