Regulatory Writing Mgrの求人情報なら転職エージェントJAC


Regulatory Writing Mgr

  • 転勤なし
  • 週休二日制
  • 上場
  • 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

<Group Purpose>

To prepare scientific and regulatory documents that comply with global regulatory standards

<Job Summary>

To prepare and oversee the preparation and senior management approval of scientific and regulatory documents. To serve as functional area lead on product teams. To manage the work of GRW staff.

Key business relationship includes Regulatory, Safety, Marketing, Biostatistics, and Clinical or Medical Operations.

<Key Activities>

・ Independently write and translate clinical study reports, Investigator Brochures, Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, Risk Management Plans, Response to regulatory questions

・ Prepare and managed the preparation of other regulatory documents and CTD sections, as appropriate (Modules 2 and 5 for CTD, Risk Management Plans, Responses to regulatory agency questions, protocols, statistical analysis plans)

・ Provide functional area input for Local Regulatory Plan, Local Development Plan, and team goals

・ Responsible for study timelines for regulatory documents

・ Regulatory submission strategy

・ Keep abreast of professional information and technology through literature, symposia, and conferences

・ Participate in departmental and cross-departmental initiatives as appropriate

・ Provide innovation for improving departmental processes

・ Provide expertise and guidance on document design and principles of good medical writing to the department and product teams



<Basic Knowledge and Skills>

・Ability to write and speak fluent Japanese and English

・Experience reading, understanding, and applying regulations to constantly changing environment

・Ability to effectively operate in an environment which requires negotiation, persuasion, collaboration, and analytical judgment

・Experience understanding and interpreting data/information and its practical application

・Excellent written/oral communication skills and attention to detail

・Strong Time and project management

・Negotiating skills

・Perseverance with a drive for results

<Preferred Knowledge and Skills>

・Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

・Knowledge of management skills and supervising the work of others

・Understands the core business process and purpose of the functional area in Amgen’s commercialization process

・Strong Leadership in a team environment

・Strong negotiator

・Mentoring, training and directing others

・Developing and delegating to direct reports with a drive for results

<Education & Experience (Basic)>

Doctorate degree and 3 years of directly related experience


Master’s degree and 6 years of directly related experience


Bachelor’s degree and 8 years of directly related experience

<Education & Experience (Preferred)>

-Industry experience

-8+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)


年収 900万円 - 1500万円