Manager or Associate, Medical Writingの求人情報なら転職エージェントJAC


Manager or Associate, Medical Writing

  • 転勤なし
  • 週休二日制
  • 外資



会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>


雇用形態 正社員(期間の定めなし)
勤務地 東京都

Responsibilities will include, but are not limited to, the following:

1. Working with other relevant line functions, prepare phase 1 ・ IV clinical and regulatory documents and submissions, including Investigator Brochures, clinical study reports, registration dossiers, package inserts, responses to health authorities and post-marketing surveillance report.

2. Participate in project team meetings and assist the teams in resolving issues related to document preparation.

3. Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.

4. Prepare internal guidelines for document preparation.

5. Prepare templates for clinical documents that are consistent with ICH guidelines and local requirements.

6. Develop the strategy for document preparation, including time frames that meet or exceed company standards and the document review processes.

7. Facilitate document review meetings and discussions and track the progress.

8. Participate in the development of outsourcing plans for medical writing.

9. Manage outsourced medical writing projects.

10. Review work of other writers (in-house or contract) for accuracy, quality, focus, and adherence to format and stylistic requirements.

11. Train and guide other writers (in-house or contract) in company policies and procedures related to document preparation.

12. Assist with preparation of presentations for major external meetings.

13. Assist with transferring and presenting clinical / regulatory data to Marketing for journal submissions.



・ Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use

・ Knowledgeable in preclinical development including discovery, toxicology etc.

・ Knowledge of ICH guidelines and local requirements

・ Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD)

・ Ability to work with complex projects and within cross-functional teams

・ Experience working with CROs


年収 900万円 - 1200万円