【企業の特徴】
外資系バイオ医薬品企業

<ポジションサマリー>

• 日本向け規制文書の作成を主導し、CTDやPMDA向け資料を高品質に仕上げる役割
• 深い科学的理解と規制知識を活かし、グローバルと連携しながら文書戦略と品質を牽引します

【仕事内容】
■About the Role

The Medical Writer (Director-level) will lead the development of Japan-specific regulatory documents required for submissions to Japanese regulatory authorities (PMDA/MHLW), including CTD modules, consultation briefing documents, and responses to PMDA inquiries.

This role is highly hands-on, requiring deep scientific understanding, strong regulatory writing expertise, and close coordination with both Japan-based and global stakeholders.

The incumbent will serve as the primary Medical Writing point of contact in Japan, ensuring alignment with Global Medical Writing and Trial Transparency & Disclosure (TT&D), while applying advanced knowledge of ICH, including ICH M4, and PMDA regulatory requirements, to produce high-quality and compliant documentation.

Although the direct reporting line for this role is to the Head of Clinical Development Japan, the position will also maintain a dotted-line functional relationship with the Global Head of Medical Writing to ensure scientific alignment, adherence to global standards, and consistency in document quality across regions.

■What You'll Do

Regulatory Medical Writing Lead for PMDA/MHLW Submissions

• Lead authoring, translation/adaptation, and quality review of CTD documents for Japan.
• Apply deep understanding of ICH M4 (CTD structure) and PMDA-specific CTD guidance when preparing documents.
• Develop and manage timelines for Japan-specific regulatory documents, including CTD modules, PMDA consultation materials, and other documents required for submission to Japanese regulatory authorities (PMDA/MHLW), and ensure alignment on document strategy with Global Medical Writing, Regulatory Affairs, and cross-functional teams.
• Prepare PMDA consultation briefing documents (BD) and coordinate cross-functional inputs.
• Support the drafting of PMDA inquiry responses in close collaboration with Subject Matter Experts (SMEs), ensuring scientific rigor and regulatory consistency.
• Support and collaborate with Subject Matter Experts (SMEs) in preparing documentation required for Clinical Trial Notifications (CTNs), ensuring accuracy, clarity, and regulatory alignment.
• Apply knowledge of ICH, PMDA, and regulatory/scientific standards using sound judgment and prior experience.

Document Development & CRO Oversight

• Oversee translation of Protocols, IBs, and other clinical documents performed by CROs in collaboration with CTO.
• Manage document version control, storage, and document management systems.
• Select, contract, coordinate, and QC CROs for outsourced writing or translation work.
• When documents are not outsourced, lead the adaptation, drafting, and editorial preparation of Japan-specific regulatory documents, such as Japan CTD, PMDA consultation materials, and inquiry responses, based on scientific content provided by SMEs.

Cross-Functional Collaboration

• Collaborate with Japan Program Team to collect information and generate PMDA documentation.
• Partner with Global Medical Writing and TT&D to ensure consistency with global templates, messaging, and standards.
• Represent Japan MW requirements and regulatory perspectives in cross-functional and global discussions.

Scientific and Strategic Contribution

• Serve as a scientific contributor with strong understanding of clinical development, statistics, SAPs, and clinical data interpretation.
• Ensure that Japan-specific regulatory documents reflect high scientific quality and regulatory readiness, while maintaining alignment with global content where applicable.
• Contribute to process improvement and standard development within Medical Writing.

Leadership & Mentorship

• Provide guidance to global or regional colleagues regarding document planning, content, and Japan-specific expectations.
• Offer peer review and cross-functional coaching when needed.
• Uphold and role-model company's values: Collaboration, Accountability, Passion, Respect, Integrity.

■Travel

Willingness and ability to travel approximately 10% (domestic and international), including overnight travel as required.

【応募資格】
■Language

• Native-level proficiency in Japanese, and business-level proficiency in English(written and spoken). The role requires the ability to actively participate in meetings, clearly communicate complex concepts, and engage in scientific discussions with global and Japan-based stakeholders

■Experience / Knowledge

• 10+ years of professional experience involving hands-on regulatory writing for PMDA submissions (e.g., CTD modules, consultation briefing documents, inquiry responses).
• At least 3 years of this experience must be in a dedicated Medical Writing department or an equivalent function with formal Medical Writing responsibilities.
• Deep experience with PMDA submissions (CTD, BD, Q&A, CTN).
• Advanced understanding of ICH guidelines, including E3, E6, E9, E17, and particularly ICH M4 (CTD structure), as well as PMDA-specific CTD guidance.
• Strong knowledge of clinical development, statistical concepts, SAPs, and clinical data interpretation.
• Experience managing CROs for writing, translation, and document QC.
• Knowledge of document management systems and structured version control processes.
• Familiarity with AMA Manual of Style or equivalent scientific writing conventions.

■Skills / Capabilities

• Excellent scientific and regulatory writing skills in Japanese and English.
• Ability to independently interpret and present scientific/clinical data.
• Ability to apply ICH and PMDA requirements, including ICH M4 CTD structure, consistently across documents.
• High attention to detail, strong commitment to document quality.
• Exceptional project management skills; able to manage multiple deliverables and aggressive timelines.
• Strong cross-functional communication and negotiation skills.
• Proactive, self-directed, adaptable, and effective within a global matrix environment.
• Ability to work successfully in a culturally diverse international setting.

■Qualifications / Certificates

• Bachelor's degree in life sciences, pharmacy, medicine, or related field (Master's/PhD preferred).
• Formal training or certification in medical writing/regulatory writing is an advantage.

【給与】
万円 (スキル・経験により決定)

【Job Reference ID】:
JO

【英語力】:
ビジネスレベル以上

【日本語力】:
Fluent – Native level (Equivalent to JLPT N1)

【待遇・福利厚生】:
社会保険完備

【休日休暇】:
完全週休二日制(土曜、日曜、祝日)、年末年始休暇、年次有給休暇

*【選考プロセス】*
:
書類選考、面接数回を予定

雇用形態 :
正社員