Medical Writer II, 在宅勤務可

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

📋 Description

• Creation and editing of clinical-related documents (such as clinical trial protocols, informed consent forms, clinical study reports, CTD, etc.) in the development of pharmaceuticals and medical devices.

• Development and editing of safety reporting documents (including DSUR, PBRER, etc.).

• Writing and editing of manuscripts and abstracts.

• Directly respond to client requests.

• Collaborate with other departments such as Medical, Statistics, Clinical Operations, and Regulatory Affairs.

• Execute document creation projects.

• Opportunity to communicate directly with medical writers from other countries and clients from global companies.

• Create documents on unfamiliar topics and requirements from various countries with the support of SMEs.

⛳️ Requirements

• Over 5 years of experience in the pharmaceutical industry.

• More than 3 years of experience as a medical writer.

• Document creation experience as a medical writer for CTD, clinical study reports, and clinical trial protocols.

• Experience in writing manuscripts is a plus.

• Strong oral and written communication and coordination skills in both Japanese and English.

• Experience facilitating meetings in English is preferred.

• Excellent writing skills, communication abilities, and problem-solving skills.

• Ability to approach challenging situations flexibly and sincerely.

• Strong emphasis on teamwork and the ability to actively support colleagues.

• Capability to share personal knowledge and experience with others.

🏝️ Benefits

• SME mentoring support system provided by experienced medical writers.

• Opportunities to enhance specialized knowledge with SMEs from other regions as a regional SME.

• Internal SOPs and various document templates that are regularly updated based on industry trends.

• Frequent training sessions for information sharing.

• Option for remote work.