Title: Manager-1 Global Medical Writing

Date: Sep 4, 2024

Location: Gurgaon - R&D

Company: Sun Pharmaceutical Industries Ltd

Responsibilities:
Preparation of the 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, clarity, accuracy, format, and consistency with adherence to regulatory guidelines and applicable standards, styles, 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 timelines of documents, scheduling kick-offs 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 timelines.
Plan and organize project and non-project meetings as and when required.
Facilitate effectiveness interactions and information communication among co-authors and reviewers as appropriate (including problem-solving and resolution of issues).
Keep abreast of project status, clinical operating plans, and ongoing/new studies as well as scientific literature within assigned project.
Maintain and develop current knowledge of regulatory guidelines, technological advances, and industry standards.
Maintain metrics, tracking sheets, and training records as per the process requirements.
Attend training sessions as per the process requirements.
Perform departmental activities as per the requirements.