Medical Writing

Location: Mumbai/ Pune

Salary – Upto 15 LPA (Depends on last Salary)

5 Days Work

2 Days Rotational Off

Cabs Available

Night Shift Allowance

Job Description

• Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas.
• Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules.
• Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required.
• To work in coordination with all the members in the study team- internal and external for the development of clinical documents.
• Share project timelines amongst the study team for the development of document.
• Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document.
• Review statistical analysis plans and table/figure/listing, when required.
• Ensure uniformity and consistency in the scientific content of the regulatory documents
• Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies.
• Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes.
• Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists.
• Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc.
• Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines.
• Plan and organize project and non-project meetings, as and when required