Senior Specialist or Manager, Publication Development, Evidence Solution Group
Senior Specialist or Manager, Publication Development, Evidence Solution Group
Posted on :
05-06-2025
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1 Vacancy
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Job Description
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.
Qualifications :
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:
- Bachelors 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.
- Bachelors degree in science with experience in clinical research.
- Masters 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.).
:
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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