Medical Compliance Manager

外資製薬メーカーにてMedical Compliance Manager

仕事内容

Accountabilities for company compliance management

・To be familiar with the rules in the pharmaceutical industry and advises all departments in
business from the viewpoint of legal affairs and compliance.
・Bridging the Global SOP and regional rules to create and update the appropriate SOP.
・Catching trends in rule changes at authorities and industry groups promptly and reflect them
in the internal SOP.
・Audit and supervise information provision activities for internal and external stakeholders.
Participate in the in-house approval flow and examine each project from the viewpoint of
compliance.
・Create a violation prevention program by actively verifying in-house compliance violations.
Perform regular verification, report to management and prevent recurrence by the program.
・Conduct regular compliance training for internal companies and partner companies in
collaboration with the internal training department.
・Requesting advice from external advisors for maintaining appropriate compliance within the
company.

Medical information management
・Create or review materials appropriate for information provision activities, based on the
product material creation rules instructed by Japanese authorities and HQ.
・Be familiar with the information about company product and provide scientific advice to
external and internal stakeholders.
・Verify scientific evidence from in-house materials and articles. Reflect appropriate
information on sales and medical materials.
・Support Field Medical activities by providing appropriate information for medical activities
based on the latest evidence and guidelines announced at academia and societies.
・Support for publication of papers written in-house or by the Investigator.
・Properly provide information according to information required from external stakeholders (Q
& A at call center and reception of external complaints regarding information provision
activities and their response).

Other Duties
・Multiple response for external inquiries and reports
・Collaborative work with other departments
・Other duties as required or directed by the Manager or Functional Management

応募条件

【必須事項】

・Over 3yrs experience in pharmaceutical compliance field
・Familiar with legal rules in the pharmaceutical industry, code of practice and MHLW
guideline for activities of information provision
・Tertiary health/science related qualification
・Outstanding communication, writing and presentation skills
・Ability to learn and effectively convey clinical and non-clinical information and international
scientific/medical publications information in Japan
・Ability to work in teams and autonomously.
・Strong business acumen
・Japanese native

【歓迎経験】

・A high science degree, such as Pharmacist, Masters, Ph.D.
・Communication, writing and presentation skills in English (practical skills)
・Collaboration work with pharmaceutical company and vendors
・People management

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員、契約社員

試用期間

3ヶ月

契約期間

勤務地

東京都

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

9：00~17:30

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

土日、祝日、夏期休暇、冬期休暇、5月1日、慶弔休暇、創立記念日、有休（入社初年度20日支給）

年収・給与

年収　　700万円～1000万円　経験により応相談

諸手当

交通費など

昇給

年1回

賞与

年2回

採用人数

1名　

待遇・福利厚生

【待遇】

退職金制度、旅行補助金制度、スポーツクラブ補助、語学研修補助（英語・フランス語）など

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）最終面接