๐ Core Information
๐น Job Title: Clinical Regulatory Writer (CReW)
๐น Company: AstraZeneca
๐น Location: Osaka or Tokyo, Japan
๐น Job Type: Full-time
๐น Category: Research & Development
๐น Date Posted: May 9, 2025
๐น Experience Level: 2-5 years
๐น Remote Status: On-site
๐ Job Overview
Key aspects of this role include:
- Leading the authoring of clinical parts of regulatory documents
- Ensuring quality and efficiency in document delivery
- Coordinating external vendors for CSP/MICF/IB development
- Contributing to briefing documents for PMDA consultations
- Reviewing clinical documents to support product claims and labels
ASSUMPTION: This role requires strong medical writing skills, knowledge of drug development processes, and the ability to work effectively with cross-functional teams.
๐ Key Responsibilities
โ
Author clinical parts of regulatory documents such as CSP, MICF, CSR, IB, CTD, and regulatory defences
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Lead or contribute to the authoring of clinical parts of briefing documents for PMDA consultations
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Review clinical documents to facilitate the translation of target product claims into a fully-supported proposed product label
โ
Coordinate external vendors for CSP/MICF/IB development
โ
Ensure quality and efficiency in document delivery
ASSUMPTION: This role requires a strong attention to detail, the ability to work independently, and the capacity to manage multiple projects simultaneously.
๐ฏ Required Qualifications
Education: Bachelorโs Degree in Science or related discipline
Experience:
- Proven experience in medical communications within the pharmaceutical industry or a medical communications agency
- Experience in delivering regulatory submissions, including CTN, JNDA/sJNDA, and responding to PMDA/MHLW queries during review
Required Skills:
- Proficient medical writing skills in Japanese and English
- Logical thinking and presentation skills
- Strong interpersonal and communication skills
- Facilitation skills to lead innovative solutions in conflicting discussions
- Knowledge of drug development processes, including regulations and guidelines (e.g., GCP, ICH GLs)
Preferred Skills:
- Experience leading the preparation of clinical regulatory documentation
- Experience supporting documentation preparation across program and strategy levels
- Experience supervising internal communication and outsourced writing
- Experience with digital tools/technologies in medical writing
ASSUMPTION: Candidates with experience in leading clinical regulatory documentation projects and supporting documentation preparation across program and strategy levels will be highly competitive for this role.
๐ฐ Compensation & Benefits
Salary Range: Industry standard for a mid-level medical writer in Japan is approximately ยฅ6,000,000 - ยฅ8,000,000 per year. This estimate is based on market research and comparable roles in the region.
Benefits:
- Competitive benefits package
- Opportunities for professional development and growth
- Collaborative and inclusive work environment
Working Hours: Full-time position with standard working hours (8:30 AM - 5:30 PM, Monday to Friday) and occasional overtime as needed
ASSUMPTION: The salary range provided is an estimate based on market research and may vary depending on the candidate's experience and qualifications.
๐ Applicant Insights
๐ Company Context
Industry: AstraZeneca operates in the pharmaceutical manufacturing industry, focusing on the discovery, development, and commercialization of prescription medicines, primarily in three therapy areas: Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
Company Size: AstraZeneca is a large, global organization with over 77,000 employees worldwide. This size offers opportunities for career growth and exposure to diverse projects and teams.
Founded: AstraZeneca was founded in 1999 through the merger of Astra AB and Zeneca Group plc.
Company Description:
- AstraZeneca is a global biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines
- The company has a portfolio of medicines for cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, neuroscience, and rare diseases
- AstraZeneca is committed to advancing science and improving patient outcomes through innovative medicines
Company Specialties:
- Pharmaceutical manufacturing
- Research and development
- Global business
Company Website: http://www.astrazeneca.com
ASSUMPTION: AstraZeneca's global presence and diverse product portfolio provide ample opportunities for career growth and development within the organization.
๐ Role Analysis
Career Level: This role is at the mid-level (E) within AstraZeneca's career framework, indicating significant experience and responsibility in medical writing and regulatory affairs.
Reporting Structure: The Clinical Regulatory Writer (CReW) will report directly to the Regulatory Affairs Manager and work closely with cross-functional teams, including clinical, medical, and legal affairs.
Work Arrangement: This role is on-site, with the option to work in either Osaka or Tokyo. Occasional remote work may be possible, depending on the company's policies and the employee's performance.
Growth Opportunities:
- Progression to senior medical writing or regulatory affairs roles
- Expansion into other therapeutic areas or functional roles within AstraZeneca
- Development of leadership and management skills through mentoring and training opportunities
ASSUMPTION: Given AstraZeneca's size and global presence, there are numerous opportunities for career growth and development within the organization.
๐ Location & Work Environment
Office Type: AstraZeneca's offices in Osaka and Tokyo are modern, collaborative workspaces designed to foster innovation and productivity.
Office Location(s): Osaka or Tokyo, Japan
Geographic Context:
- Osaka is Japan's second-largest metropolitan area, with a vibrant economy and rich cultural heritage
- Tokyo is the capital of Japan and a major global hub for finance, technology, and culture
Work Schedule: Standard working hours are from 8:30 AM to 5:30 PM, Monday to Friday, with occasional overtime as needed.
ASSUMPTION: The work environment at AstraZeneca is collaborative and inclusive, with a strong emphasis on teamwork and open communication.
๐ผ Interview & Application Insights
Typical Process:
- Online application submission
- Phone or video screening with the hiring manager
- In-depth interviews with cross-functional team members
- Final interview with the Regulatory Affairs Manager
Key Assessment Areas:
- Medical writing skills and experience
- Knowledge of drug development processes and regulations
- Interpersonal and communication skills
- Problem-solving and analytical skills
Application Tips:
- Tailor your resume and cover letter to highlight your medical writing experience and relevant skills
- Prepare examples of your medical writing work, demonstrating your ability to communicate complex scientific information clearly and effectively
- Research AstraZeneca's company culture and values to ensure a strong fit
ATS Keywords: Medical writing, regulatory affairs, drug development, clinical trials, ICH guidelines, GCP, PMDA, MHLW, CSP, MICF, CSR, IB, CTD
ASSUMPTION: AstraZeneca's application process is designed to assess candidates' technical skills, cultural fit, and potential for growth within the organization.
๐ ๏ธ Tools & Technologies
- Microsoft Office Suite (Word, PowerPoint, Excel)
- Regulatory submission software (e.g., eCTD, Veeva Vault)
- Medical writing software (e.g., Authentiq, Vantage)
ASSUMPTION: Familiarity with relevant medical writing and regulatory submission software is an asset for this role.
๐ Cultural Fit Considerations
Company Values:
- Patient-centricity
- Science-driven
- Integrity
- Innovation
- Performance
Work Style:
- Collaborative and inclusive
- Focused on delivering results and driving innovation
- Committed to continuous learning and development
Self-Assessment Questions:
- How do you demonstrate patient-centricity in your medical writing?
- Can you provide an example of a time when you had to balance multiple priorities and deadlines in a medical writing project?
- How do you approach learning new therapeutic areas or regulatory requirements?
ASSUMPTION: Candidates who can demonstrate a strong fit with AstraZeneca's values and work style will be highly competitive for this role.
โ ๏ธ Potential Challenges
- Managing multiple projects and deadlines simultaneously
- Navigating complex regulatory requirements and guidelines
- Working effectively with cross-functional teams and stakeholders
- Adapting to changes in therapeutic areas or regulatory requirements
ASSUMPTION: Successful candidates will be able to manage multiple priorities, adapt to change, and work effectively with cross-functional teams.
๐ Similar Roles Comparison
- Compared to other medical writing roles, this position places a greater emphasis on regulatory affairs and submission packages
- This role requires a strong understanding of drug development processes and regulations, setting it apart from more general medical writing positions
- Career progression in this role may lead to senior medical writing or regulatory affairs positions within AstraZeneca or other pharmaceutical companies
ASSUMPTION: Candidates with experience in regulatory affairs or a strong interest in learning about the regulatory submission process will be well-suited to this role.
๐ Sample Projects
- Developing a comprehensive clinical study report (CSR) for a Phase III clinical trial
- Coordinating external vendors to create high-quality CSP/MICF/IB documents
- Reviewing clinical documents to support product claims and labels for regulatory submissions
ASSUMPTION: These sample projects demonstrate the range of responsibilities and required skills for the Clinical Regulatory Writer (CReW) role.
โ Key Questions to Ask During Interview
- Can you describe the team structure and how this role fits within it?
- How does AstraZeneca support the professional development and growth of medical writers?
- Can you provide an example of a recent regulatory challenge faced by the team and how it was addressed?
- How does AstraZeneca ensure the quality and consistency of medical writing across different therapeutic areas and regions?
ASSUMPTION: Asking thoughtful questions during the interview process demonstrates a candidate's interest in the role and organization.
๐ Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume and cover letter to highlight your medical writing experience and relevant skills
- Prepare examples of your medical writing work, demonstrating your ability to communicate complex scientific information clearly and effectively
- Research AstraZeneca's company culture and values to ensure a strong fit
- Follow up with the hiring manager one week after submitting your application to express your interest in the role
โ ๏ธ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
