Senior Medical Writer

Acts as a lead medical writer for projects at a complex level.

Independently writes documents such as CSRs, protocols, preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions.　

Independently writes, edits and compiles documents that are components of clinical/regulatory marketing approval applications for new biologics, drugs, or devices, and to direct other medical writers in the writing, editing and compilation of documents. Assists in the management of medical writing resources.

Independently provides additional medical communications writing and editing services as required (for example for manuscripts, abstracts and scientific posters). 　

Sole responsibility for interpreting and summarizing data from biostatistical summary tables and listings accurately, precisely and concisely into narrative text.

Schedules and conducts peer and team quality-control review for assigned clinical research documents and projects (at a minimum, formatting and data checks).

Liaises with internal groups, i.e. Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Research, Project Management, and/or Quality Assurance to obtain necessary and relevant information and deal with queries through effective decision making. Independently interacts with clients to obtain necessary and relevant information and deal with queries.

Keeps Medical Writing management informed of document status in relation to quality and timelines.

Provides scientific and medical writing consultancy to clients and internal colleagues at a moderate to complex level. Demonstrates ability to use computerized systems (PC-Windows and MS Word). Exhibits excellent written and oral communication and presentation skills. Is able to collaborate well at a complex level.

May serve as an active mentor to one or more junior staff members and participates in the training and supervision of new and junior medical writers. Where applicable, understands regulatory submissions requirements and clinical study report guidelines in host country.

Represents Medical Writing at internal and external meetings. Assists Business Development with the preparation of proposals and cost estimates for medical writing tasks. Performs any other duties as assigned commensurate with skills and qualifications and appropriate to the role.

Candidates should have at least 5 years of experience as a Medical Writer; candidates with less experience can be considered in they demonstrate suitable or equivalent skills.　

ICONでは国内外のクライアントのプロジェクトを牽引するシニアメディカルライターを募ります。

応募要件は以下の通りです。

・大学卒以上（医薬、獣医、農学、生命科学等の学部学科）、または同等の学位保有者

・製薬会社、またはCROにおける5年以上のメディカルライティング業務の経験

・主要な当局提出資料の作成にメディカルライターとして関与した経験

・プロトコール設計から承認申請までのプロセスや、技術的問題を含む臨床開発に関する十分な知識

・規制要件、ICHガイドライン、文書作成（CTDを含む）に関する薬事的プロセスについての知識

・ビジネスレベルの英語力　読み書きスピーキングについて業務遂行プロジェクトリードに支障がないこと