Associate Medical Writer

US Biomedical Systems India Pvt Ltd.; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive pay

Provident fund

Medical insurance

Employee programs

Remote work flexibility

Career growth

Job summary

Clario is seeking a Medical Writing professional to support study startup activities by creating and maintaining study documents, manuals, and communications. The role involves reviewing protocols, ensuring accurate interpretation, and producing compliant regulatory materials.

The ideal candidate has a life sciences background with 1+ years in medical writing, strong English skills, and attention to detail to manage multiple documents and deadlines in a global team.

Qualifications

• Experience in medical writing and documentation for clinical research.
• Familiarity with regulatory writing principles and study documentation.
• Strong command of English and excellent proofreading skills.

Responsibilities

• Prepare, organize, and maintain study-specific Medical Writing and Medical Communications documentation.
• Review protocols and imaging requirements for accurate interpretation of study procedures.
• Create and finalize Site Manuals, forms, labels, and related materials.
• Maintain compliance documentation, including Notes to File and protocol amendments.
• Develop and maintain SOPs, Work Instructions, and training materials.
• Support Medical Communications databases, web content, and document repositories.
• Assist with project closeout and archival of study documentation.

Skills

Medical writing

Documentation

Regulatory knowledge

English communication

MS Office

Attention to detail

Education

Bachelor’s in Life Sciences

Clinical Research related

Job description

What We Offer

Competitive pay and incentives. Provident fund and medical insurance. Engaging employee programs and local events. Modern office spaces and remote work flexibility. Opportunities for professional growth and career development within a global organization.

What You'll Be Doing

Support study startup activities by creating, organizing, and maintaining study-specific Medical Writing and Medical Communications documentation. Review study protocols and imaging requirements to ensure accurate interpretation of study procedures, schedules, and operational requirements. Create, update, and finalize study documentation, including Site Manuals, supporting forms, labels, and study-specific communication materials. Develop, review, and maintain compliance-related documentation, including Notes to File, protocol amendment impact assessments, corrections, and other quality records as required. Create and maintain source documentation and electronic clinical forms to support study execution and operational requirements. Prepare meeting agendas, meeting minutes, and action item documentation for study startup, project, and Medical Communications activities. Attend internal and external meetings related to study startup documentation, compliance activities, and operational deliverables. Support the maintenance and enhancement of Medical Communications resources, databases, web content, and document repositories. Assist with project closeout activities and ensure study documentation is archived in accordance with company procedures and regulatory requirements. Support the development, review, and maintenance of Standard Operating Procedures (SOPs), Work Instructions, templates, and training materials. Assist with the review and update of reader training materials, study training content, and educational resources. Maintain study tracking tools, document status reports, and Medical Writing databases to ensure accurate reporting and document control. Provide guidance and support to project teams regarding document development processes, templates, and study documentation requirements. Contribute to continuous improvement initiatives focused on quality, compliance, efficiency, and operational excellence.

What We Look For

Bachelor's degree in Life Sciences, Biological Sciences, Physical Sciences, Pharmacy, Healthcare, Clinical Research, or a related scientific discipline preferred. 1+ years of medical writing experience preferred, although equivalent clinical research or scientific documentation experience will be considered. 2+ years of experience within pharmaceutical, biotechnology, clinical research, healthcare, medical imaging, or related industries preferred. Understanding of medical, clinical research, regulatory, or scientific writing principles. Knowledge of clinical trial terminology, medical imaging concepts, and clinical research processes preferred. Strong proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and related productivity tools. Excellent written and verbal communication skills with the ability to communicate effectively in English. Strong attention to detail with exceptional proofreading, editing, and document quality review skills. Demonstrated ability to manage multiple projects, priorities, and deadlines simultaneously. Strong organizational, documentation, and time management skills. Ability to work independently while collaborating effectively within cross-functional and global teams. Adaptability and flexibility in managing changing priorities within a fast-paced environment. Professional, proactive, and customer-focused approach with a commitment to quality and continuous improvement.

At Clario, a part of Thermo Fisher Scientific, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It's a cause that unites and inspires us. It's why we come to work and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.

Clario Privacy Policy Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints. For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.