Global Pharmaceutical Company
Responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence base of product knowledge in a credible, consistent and compliant way.
経験 / Experience：
- Experience in medical communications gained through working in the pharmaceuticals industry or a medical communications agency
- A comprehensive knowledge of the drug development processes including key regulations/guidelines (e.g. GCP, ICH GLs), and knowledge on a "need to know basis" in relevant therapeutic area.
- Knowledge of policy, standard, SOPs particularly CSP/IC, CSR, IB, CTD
- 能力 / Skill-set：
- Medical writing skill Logical thinking/Presentation skill to express intention in an efficient way in Japanese & English
- Interpersonal and communication skills with team member or stakeholders
- Facilitation skill to lead an innovative solution in conflicting discussion
- Demonstrates aligned behaviours to the company leadership guideline
(Experiences and skills will be considered)
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