Medical Writer, Associate

This is a fully remote position, open to applicants in India.

📋 Description

• Assist in the initiation of studies by developing, organizing, and maintaining documentation specific to Medical Writing and Medical Communications.

• Evaluate study protocols and imaging criteria to ensure proper understanding of study procedures, timelines, and operational needs.

• Generate, revise, and complete study documents, including Site Manuals, supporting forms, labels, and communication materials tailored for the study.

• Create, review, and uphold compliance-related documentation, such as Notes to File, assessments of protocol amendments, corrections, and other quality records.

• Develop and manage source documentation and electronic clinical forms.

• Draft meeting agendas, record meeting minutes, and document action items.

• Participate in internal and external meetings concerning startup documentation, compliance tasks, and operational outcomes.

• Assist in the maintenance and improvement of Medical Communications resources, databases, web content, and document storage systems.

• Aid in project closure activities and archive study documentation in accordance with company procedures and regulatory standards.

• Support the creation, review, and upkeep of SOPs, Work Instructions, templates, and training materials.

• Help review and update training materials for readers, study content, and educational resources.

• Manage study tracking tools, document status reports, and Medical Writing databases.

• Offer guidance and support to project teams regarding document development processes, templates, and study documentation needs.

• Contribute to initiatives aimed at continuous improvement focused on quality, compliance, efficiency, and operational excellence.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Biological Sciences, Physical Sciences, Pharmacy, Healthcare, Clinical Research, or a related scientific field is preferred.

• At least 1 year of medical writing experience is preferred; equivalent experience in clinical research or scientific documentation will be considered.

• Minimum of 2 years of experience in pharmaceutical, biotechnology, clinical research, healthcare, medical imaging, or related sectors is preferred.

• Familiarity with medical, clinical research, regulatory, or scientific writing principles.

• Knowledge of clinical trial terminology, medical imaging concepts, and clinical research processes is preferred.

• Strong proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and similar productivity tools.

• Exceptional written and verbal communication skills, with the ability to communicate effectively in English.

• Strong attention to detail, with outstanding proofreading, editing, and document quality review abilities.

• Proven capability to manage multiple projects, priorities, and deadlines concurrently.

• Excellent organizational, documentation, and time management skills.

• Capacity to work independently while effectively collaborating in cross-functional and global teams.

• Flexibility and adaptability in managing shifting priorities in a fast-paced environment.

• A professional, proactive, and customer-oriented approach with a commitment to quality and continuous improvement.

🏝️ Benefits

• Competitive salary and incentives.

• Provident fund.

• Medical insurance.

• Engaging employee programs and local events.

• Modern office environments and flexibility for remote work.

• Opportunities for professional advancement and career development within a global organization.