Manager Medical Writing

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Position Details : Manager Medical Writing

Email Position to a Friend  Designation  Manager Medical Writing  Experience  3 to 5 years  Position Type Full Time  Functional Area  Scientific Content  Education B.D.S, MBBS, Ph.D  Work Location Bangalore  Job Description 1. Should be accountable for the quality, implementation, and timeliness of medical writing     deliverables, including clinical study reports (phases I–IV), clinical study protocols,     safety narratives, investigational drug brochures, summaries of efficacy and safety,     PSURs, scientific manuscripts, and abstracts 2. Work and interact extensively with clinical and regulatory experts, biostatisticians     as well as external contacts to ensure high quality with regard to scientific     content, organization, clarity, accuracy, format, and adherence to regulatory     and internal guidelines, styles, and processes 3. Provide guidance and support to all team members on a project with     regard to format, style,content, and compliance 4. Ensure that clinical documents adhere to current global standards,     FDA, ICH, and GCP guidelines and are in accordance with     electronic publishing standards 5. Guide and mentor team members to ensure consistency and completeness     of the project 6. Provide peer review for colleagues’ documents 7. Create, maintain, and disseminate medical writing training materials and     guidelines, and conduct training seminars as necessary 8. Write SOPs and/or review them for completeness and updates as needed 9. Review and write clinical proposals and project status report Desired Profile 1. Able to demonstrate thorough knowledge of FDA, ICH, and GCP     guidelines regarding thesubmission of documents in accordance     with current regulatory standards 2. Must have proven experience (minimum 4–5 years) as a scientific medical     writer in a clinical research environment and proven experience in the     management of medical documentation Soft Skills ·   Client focus ·   Result orientation ·   Communicating with Impact ·   Team player ·   Process oriented Apply here