Associate Medical Writer

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. 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.

Benefits

• 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.