BrightOwl Loader Loading

Principal Medical Consultant (m/f) - United States  

PHARMALEX (company)


Posted on : 05 July 2017

Project Description

Be a part of our growing company!
  • Are you looking to join a dynamic company where new challenges and opportunities are part of your every day work life? 
  • Then make our company  your career choice! Our company is a leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance and development consulting. 
  • We are specialized in effectively designing all aspects of drug and medicinal product registrations – ranging from early development and market entry to product maintenance activities. 
  • The success of our company resides in the expert knowledge and high motivation of our employees.
  • We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment.
  • So, if your career is much more than just a job for you but rather your passion, then come and join our successful team.

Your responsibilities
  • The Principal Medical Consultant is responsible for establishing, managing, developing and leading the cross-functional Global Medical Services of our company.
  • He or she provides strategic direction with the objective to position our company as thought leader vis-à-vis decision makers and key opinion leaders in the pharmaceutical industry, pharma associations and regulatory authorities. 
  • The position is a functional role and does initially not involve direct staff responsibility.
  • You will collaborate in designing the strategy for the medical services within Pharmacovigilance, Pharmacoepidemiology and Development Consulting & Scientific Affairs
  • You will represent the interests of  company services
  • You will assure safe and effective products, through state of the art services in medical science, epidemiology, pharmacovigilance and regulatory compliance
  • You will prepare and attend critical meetings with FDA, EMA and EU authorities and other regulatory bodies
  • You will act as medical lead “client-care officer” through direct contact with heads of pharmacovigilance, drug development or medical affairs of clients and partners
  • You will design and conduct high quality pre- and post-authorization efficacy and safety interventional and non-interventional studies to assist clients in understanding the benefit-risk, safety issues, labeling and appropriate utilization of their products
  • You will perform high level medical services in the areas of benefit risk analysis, including all related operational as well as consulting activities, e.g.: writing and reviewing of Study Outlines, Development Plans, Safety Plans, Periodic Benefit Risk Evaluation Reports, Clinical Trial Reports  medical evaluation of patient related data including case reports from clinical trials or post-marketing pharmacovigilance

Your profile
  • Medical doctor by training required, others appropriate degrees, such as MPH or DPH a plus.
  • At least ten years of strong operational experience in the biopharmaceutical industry and experience with international companies in the areas of Pharmaceutical Development and Pharmacovigilance with relevant experiences in Pharmacoepidemiology
  • At least 3 years of clinical experience in the healthcare system, specialist medical training preferable
  • Former work experience and/or membership in relevant bodies (authorities or industry)
  • Regulatory knowledge (Europe, US-FDA)
  • Ideally: working experience at a service provider
  • Ability to develop business solutions to complex problems
  • Multitasking and flexibility
  • Hands-on mentality, solution oriented, extroverted and open personality
  • Good communication skills, also in a virtual and international environment
  • Proven experience and success in developing and leading scientific and medical teams
  • Ability to work in a fast-paced dynamic environment
  • Proficient with IT / communication tools
  • Strong interpersonal and organizational skills as well as a team oriented approach
  • Fluent in English

We offer you
An exciting and varied challenge in a friendly team, with contact and interaction across all branches of the company, as well as many opportunities for personal development and job training.