会社概要

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

求人内容

Mission Statement:

The Manager of the Medical Statistics & Publication Team within the Evidence Solution Group of the Medical Division has two primary roles: medical writer and publication adviser. As a medical writer, the focus includes regulatory post-marketing surveillance (reg-PMOS), while as a publication adviser, the scope encompasses all publications.

Major Responsibilities:

• Work as a medical writer in compliance with GPSP/GCP and SOP.
• Co-develop J-PSUR (Anzensei-Teiki-Houkokusho) with the Pharmacovigilance Group and coordinate with PMDA.
• Co-develop Re-examination application materials (Saishinsa-Shinsei-Shiryou) with the Pharmacovigilance Group and coordinate with PMDA.
• Co-develop pamphlets to promote proper use, including data from reg-PMOS (Tekisei-Shiyou-Joho), with the TA team and Pharmacovigilance Group, communicating with healthcare providers (HCPs).
• Co-develop Clinical Study Report (CSR) with the TA team and support the EU/UK team for Article 46 submission.

資格

Essential Skills & Abilities:

• Knowledge of GCP, GPSP, or Ethical Guidelines for Medical and Health Research Involving Human Subjects.
• Skills to create simple programs and formulas (chi-square tests, 95% confidence intervals, etc.) using calculation and analysis tools.
• Business-level English proficiency (TOEIC score of 700 or above).
• Effective communication skills.

Education/Experience Required:

• Bachelor's degree in science with experience as a Clinical Research Associate (CRA) or Medical Science Liaison (MSL); experience as a Medical Representative (MR) applicable only within AbbVie.
• Bachelor's degree in science with experience in clinical research.
• Master's or PhD in science with experience in scientific research in industry or academia.
• PhD in epidemiology.
• Healthcare-related certification preferred (e.g., MD, pharmacist, etc.).

その他の情報

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。