Opening for the post of Manager Medical Writing @ Indegene - Bangalore, Karnataka
Skill: Medical Writing,clinical research,clinical proposals;
Exp: 3-5 years; Job Description1. Should be accountable for the quality, implementation, and timeliness of medical writing deliverables, including clinical study reports (phases IIV), clinical study protocols, safety narratives, investigational drug brochures, summaries of efficacy and safety, PSURs, scientificmanuscripts, and abstracts2. 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 processes3. Provide guidance and support to all team members on a project with regard to format, style,content, and compliance4.
Ensure that clinical documents adhere to current global standards, FDA, ICH, and GCP guidelines and are in accordance with electronic publishing standards5. Guide and mentor team members to ensure consistency and completeness of the project6. Provide peer review for colleagues documents7. Create, maintain, and disseminate medical writing training materials and guidelines, and conduct training seminars as necessary8.
Write SOPs and/or review them for completeness and updates as needed9. Review and write clinical proposals and project status reportDesired Profile1. Able to demonstrate thorough knowledge of FDA, ICH, and GCP guidelines regarding thesubmission of documents in accordance with current regulatory standards2. Must have proven experience as a scientific medical writer in a clinical research environment and proven experience in the management of medical documentationSoft Skills Client focus Result orientation Communicating with Impact Team player Process oriented
Click here to apply
Skill: Medical Writing,clinical research,clinical proposals;
Exp: 3-5 years; Job Description1. Should be accountable for the quality, implementation, and timeliness of medical writing deliverables, including clinical study reports (phases IIV), clinical study protocols, safety narratives, investigational drug brochures, summaries of efficacy and safety, PSURs, scientificmanuscripts, and abstracts2. 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 processes3. Provide guidance and support to all team members on a project with regard to format, style,content, and compliance4.
Ensure that clinical documents adhere to current global standards, FDA, ICH, and GCP guidelines and are in accordance with electronic publishing standards5. Guide and mentor team members to ensure consistency and completeness of the project6. Provide peer review for colleagues documents7. Create, maintain, and disseminate medical writing training materials and guidelines, and conduct training seminars as necessary8.
Write SOPs and/or review them for completeness and updates as needed9. Review and write clinical proposals and project status reportDesired Profile1. Able to demonstrate thorough knowledge of FDA, ICH, and GCP guidelines regarding thesubmission of documents in accordance with current regulatory standards2. Must have proven experience as a scientific medical writer in a clinical research environment and proven experience in the management of medical documentationSoft Skills Client focus Result orientation Communicating with Impact Team player Process oriented
Click here to apply
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