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.
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 CollaborationCollaborate 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
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