• Translate/Localize and perform creative writing for gaming contents from Simplified Chinese to Japanese • Collaborate closely with the localization team and development team

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA • Write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, internal/external facing labeling documents (eg, CCDS/CCSI, annotated draft labels, IFU, patient leaflets, etc), and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc) • Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards • Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences • Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content • Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents • Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents • Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas.

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including but not limited to FDA and EMA • Write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc) • Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards • Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences • Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content • Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress • Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

• Write and edit a wide range of regulatory documents • Perform independent QC reviews of documents produced by the regulatory writing function • Verify the accuracy and internal/external consistency of documents • Define and confirm the scope of QC activities with document authors • Review documents for adherence to applicable style guides • Proofread and copyedit text to ensure clarity and accuracy • Support preparation and inspection‑readiness of technical documents • Communicate QC findings clearly and constructively to stakeholders • Facilitate the efficient project management of individual document workflows • Contribute to the continuous improvement of QC tools, checklists, and processes