Associate Medical Writer in भारत

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Associate Medical Writer based in Bangalore, India, with remote work options in India. We are seeking a detail-oriented Associate Medical Writer to support clinical trial documentation, study startup activities, and medical communications within a clinical research environment. In this role, you will create, review, and maintain high-quality scientific and operational documents that contribute to the successful execution of medical imaging studies. You will collaborate with cross-functional teams to ensure documentation accuracy, regulatory compliance, and adherence to established quality standards. Your work will support study teams throughout the clinical trial lifecycle, from startup and ongoing operations to project closeout. You will also contribute to improving document management processes, developing training materials, and maintaining essential study resources. This is an opportunity to grow your medical writing expertise while contributing to clinical research that helps advance the development of treatments and therapies worldwide. Accountabilities - Study Startup Documentation: Support study startup activities by preparing, organizing, and maintaining study-specific medical writing and medical communications documentation. - Protocol and Imaging Requirements Review: Review clinical study protocols and imaging requirements to understand study procedures, schedules, and operational expectations accurately. - Clinical Study Document Development: Create, update, review, and finalize study documentation, including site manuals, supporting forms, labels, and study-specific communication materials. - Compliance and Quality Documentation: Prepare and maintain Notes to File, protocol amendment impact assessments, correction records, and other documentation required to support quality assurance and regulatory compliance.

- Clinical Forms and Source Documentation: Develop and maintain source documents and electronic clinical forms to support study execution and operational activities. - Meeting Coordination and Documentation: Prepare agendas, meeting minutes, and action item records for study startup, project meetings, and medical communications activities. Participate in internal and external meetings as required. - Medical Communications Resources: Help maintain and improve medical communications resources, databases, web content, and document repositories to ensure information remains accurate and accessible. - Project Closeout and Archiving: Support study closeout activities and ensure documentation is archived according to established procedures and applicable regulatory requirements. - SOPs and Training Materials: Assist in developing, reviewing, and updating standard operating procedures (SOPs), work instructions, templates, and training materials. - Educational and Reader Training Content: Support the review and revision of reader training materials, study training content, and educational resources. - Document Control and Tracking: Maintain study tracking tools, document status reports, and medical writing databases to support accurate reporting, version control, and timely delivery. - Project Team Support: Provide guidance on documentation processes, templates, and study-specific writing requirements to help teams maintain consistent quality standards. - Continuous Improvement: Contribute to initiatives that improve documentation quality, compliance, operational efficiency, and overall project delivery. Requirements - Education: Bachelor’s degree in Life Sciences, Biological Sciences, Physical Sciences, Pharmacy, Healthcare, Clinical Research, or a related scientific discipline preferred. - Medical Writing Experience: At least 1 year of medical writing experience is preferred.