Job
Description
Outpace Consulting Services is seeking a Medical Writer specializing in Life Sciences and Clinical Studies for a leading ITES company. This role is responsible for developing clear, accurate, and well-structured medical and scientific documents for various audiences, including regulatory authorities. You'll translate complex clinical and scientific data into understandable content for regulatory submissions, clinical trial documentation, and other critical materials. The ideal candidate will have strong writing skills, a solid understanding of medical terminology and research practices, and experience with regulatory submission formats. Key Responsibilities: Clinical Document Preparation: Prepare and review clinical documents for regulatory submission, including but not limited to Protocols, Clinical Study Pharmacology Reports, Clinical Study Reports, Narratives, Post-Approval Documents, Clinical Summary of Safety, Clinical Summary of Efficacy, and Common Technical Document (CTD) Modules across various Therapeutic Areas. Quality Assurance: Conduct thorough quality checks of all clinical documents intended for regulatory submission, ensuring scientific content, organization, clarity, accuracy, format, and consistency meet high standards and regulatory guidelines. Regulatory Compliance: Ensure all prepared medical writing documents adhere to Standard Operating Procedures (SOPs), Document Standards, Guidance documents, regulatory guidelines, and applicable standards/styles. Team Coordination: Initiate start-up meetings with study teams, and work in close coordination with all internal and external study team members for the creation and development of clinical documents. Share project timelines with the study team. Data Review & Integration: Review statistical analysis plans and table/figure/listing, when required, ensuring uniformity and consistency in the scientific content of all regulatory documents. Project Management Support: Take an active role in assigned projects for planning content, format, and timing of documents, and report scheduling/tracking. Provide support to the clinical development or project team to meet project needs and department standards within established timelines. Peer Review & Quality Control: Perform peer review and quality control review of documents within established timelines, adhering to applicable guidelines and processes using appropriate checklists. Required Qualifications: Experience: Minimum 1 year of experience in eCTD / NEES / Docubridge . Demonstrated experience in making Clinical Study Reports and Clinical Summary of Safety . Education: Any Life Science Graduate. Skills: Strong writing skills, attention to detail, and a solid understanding of medical terminology and research practices. To Apply: WhatsApp Hi to +91 9151555419 . Then, follow these steps: Click on Start option to Apply and fill the details. Select the location as Other (to get multiple location options). a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 396
