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Manager/Sr. Manager Medical Information

Manager/Sr. Manager Medical Information

Requisition ID 
2017-9824
Job Locations 
US-NJ-Princeton

Opportunity Details

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.   

 

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Responsibilities

The Senior Manager or Manager of Medical Information provides accurate, unbiased, balanced, and timely responses to unsolicited medical and clinical inquiries regarding the Company's products from healthcare professionals, patients, clinical sites and managed care organizations.

  • Receives, documents, and responds to written medical information requests. Provides information upon request for medical and clinical inquiries from consumers, clinical sites and healthcare professionals regarding Otsuka products, including, but not limited to, product information and support.
  • Updates and/or creates medical letters pertaining to Otsuka products.
  • Limits corporate liability by meeting the medical ethical and legal responsibilities of providing product/device related information.
  • Serves as an educational resource to both internal and external customers.
  • Provides process training to sales representatives as needed.
  • Recognizes and gathers, according to FDA guidelines and company policies, initial information regarding any product complaint or adverse event of which made aware during the handling of medical information and medical device inquiries.
  • Contributes to interdepartmental projects, and supports the provision of medical, scientific and technical information regarding Otsuka products.
  • Provide assistance and/or training to other medical information personnel (i.e. consultants).

Attends and participates as an advocate of the Medical Affairs department on special projects and external medical conferences to represent Otsuka Pharmaceutical Development & Commercialization, Inc.

Qualifications

Required:

PharmD, MD, PhD preferred with a minimum of 2-4 years experience in clinical practice or pharmaceutical industry.

  • Relevant residency/fellowship preferred.
  • Experience in providing Medical Information
  • Excellent computer skills with Word, Excel, PowerPoint, Outlook
  • Strong scientific/medical written and verbal communication skills required.
  • Ability to independently write medical letters
  • Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
  • Knowledge of ICH guidelines, FDA Drug and Device Regulations with respect to DDMAC, PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and OIG Compliance Program Guidance for Pharmaceutical Manufacturers.

Preferred:

  • Experience in Neuroscience, Cardiovascular products, medical devices

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