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Bengaluru, Karnataka, India
Hybrid
Not Available
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.
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.
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. Equivalent experience in clinical research or scientific documentation may also be considered.
Industry Experience: At least 2 years of experience in pharmaceutical, biotechnology, clinical research, healthcare, medical imaging, or a related industry is preferred.
Scientific and Clinical Knowledge: Understanding of medical writing, scientific documentation, clinical research principles, and relevant regulatory requirements.
Clinical Research Familiarity: Knowledge of clinical trial terminology, clinical research processes, and medical imaging concepts is an advantage.
Technical Proficiency: Strong working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook, along with related productivity tools.
Written and Verbal Communication: Excellent English communication skills, with the ability to prepare clear, accurate, and well-structured scientific and operational documents.
Editing and Quality Review: Exceptional attention to detail, proofreading, editing, and document review skills to maintain accuracy, consistency, and compliance.
Organization and Time Management: Ability to manage multiple projects, competing priorities, and deadlines while maintaining high-quality deliverables.
Collaboration and Independence: Ability to work independently while collaborating effectively with cross-functional and geographically distributed teams.
Adaptability: Flexibility in responding to changing priorities and evolving project requirements in a fast-paced clinical research environment.
Professional Approach: Proactive, organized, and customer-focused, with a strong commitment to quality, compliance, continuous learning, and operational improvement.
Competitive compensation and incentive opportunities.
Provident fund benefits.
Medical insurance coverage.
Remote work flexibility and access to modern office facilities.
Employee engagement programs and local events.
Professional development opportunities and potential for long-term career growth.
Experience working with global clinical research teams and contributing to medical imaging studies.
Opportunities to strengthen expertise in medical writing, clinical documentation, regulatory compliance, and scientific communications.
