Assoc Dir Medical Affairs

US-NJ-Princeton
Requisition ID
2017-9879

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

Product Commercialization and Development 

  • Support Director Medical Affairs in serving as member of development and brand teams for Otsuka neuroscience products. 
  • Support Director Medical Affairs in providing medical input to all aspects of product development and promotion across the entire product lifecycle.
  • Support Director Medical Affairs in reviewing clinical results and developing appropriate communication vehicles (i.e., publications, posters, presentations, PR, etc.).
  • Supports the execution of medical affairs strategic plan for Otsuka products
  • Reviews medical content of promotional materials for accuracy as part of promotional review committee 
  • Identifies and develops relationships with external consultants, KOLs, investigators and vendors
  • Participates in extramural conferences and scientific meetings to maintain awareness of research in the field.
  • Support Director Medical affairs in applying strategic intent of OAPI when working with FDA, opinion leaders, prescribers and consumers of OAPI products
  • Manage and execute Phase 4 studies as needed
  • Manage and execute publication plan for Otsuka products as needed
  • Manage Investigator Sponsored Trials as needed

In-house Customer Support

  • Provide content resources to Field Medical Affairs consistent to Medical Affairs strategy 
  • Coordinates with sales management to provide training to sales staff.
  • Keeps abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to clinical staff and other project team members, as needed.
  • Serves as a source of medical expertise on Otsuka clinical trials for in-house customers

Medical Information and Grants Support

  • Provides direction for medical information specialists. 
  • Provides technical assistance to medical information specialists.
  • Review grant requests as needed

 

Qualifications

Required:

  • M.D. degree of a recognized school of medicine, PhD, or PsyD with + 3 years experience in pharmaceutical industry Medical Affairs specifically for neuroscience products
  • Pharmaceutical industry experience in Medical Affairs or Clinical Development (+ 6 years experience) for neuroscience products would also be considered.
  • Excellent communication and interpersonal skills
  • Good knowledge of OPDP promotional regulations and pharmaceutical promotion standards
  • Good knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals

Travel (approximately 20%)

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