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Job Details

Director, Medical Affairs

Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Reference: 26811
Closing Date: 08 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Director of Medical Affairs provides leadership to the global medical function including medical monitoring. Collaborates with the Global Vice President, Medical and Regulatory Affairs on the ongoing development of the Medical Department and contributes to the business plan at both the tactical and strategic level. Directly and through subordinate managers, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal...

Requirements:

Overview

The Director of Medical Affairs provides leadership to the global medical function including medical monitoring. Collaborates with the Global Vice President, Medical and Regulatory Affairs on the ongoing development of the Medical Department and contributes to the business plan at both the tactical and strategic level. Directly and through subordinate managers, ensures the successful management of medical advisory and medical monitoring projects in compliance with federal regulations, ICH Guidelines, Good Clinical Practices (GCPs) and SynteractHCR Standard Operating Procedures (SOPs). Develops Drug Development Plan service. Additionally, this position involves cross-functional communications, strategic planning, participation in clients’ strategic decision-making, physician review, medical monitoring and critical interactions with scientific advisors. The Director Medical Affairs is also responsible for assigning respective teams and coordination of the Medical Monitoring support provided for sponsors in overseeing medical issues all projects. 

 

Responsibilities

  • Participates in Business Development activity by means of meeting existing and potential clients to present company’s medical expertise and ability to efficiently resolve sponsor’s tasks
  • Develops Drug Development Plan service on global scale and consultancy advice in related areas internally and to sponsors as required
  • Assigns individuals to work as Medical Advisor and Medical Monitor for the projects
  • Ensures that resource planning for the Medical Advisor and Monitoring team is done according to company standards and in collaboration with other departments in case of split functions
  • Assures that Medical Advisors and Medical Monitors are adequately trained 

Qualifications

 

Academic & Professional Qualifications:

  • Medical Doctor (M.D.) is required 
  • 10+ years Medical Affairs experience or equivalent combination of education and experience
  • 5+ years’ experience effectively managing results in terms of costs, methods and/or employees
  • Minimum 1-2 years effectively contributing to the business plan at both the tactical and strategic levels

Skills & Experience:

  • Oncology Experience Required.
  • In-depth knowledge of medical terminology and of GCP, ICH guidelines relevant to global drug safety and drug development process and regulations
  • Excellent proficiency in Microsoft Word, Excel, and PowerPoint, etc.
  • Effective verbal and writing skills; English + local language, if relevant

Work Arrangements:

  • This role can be located in our Carlsbad, CA or Morrisville, NC offices
  • Work is performed in a standard office environment with minimal exposure to health or safety hazards

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.


Apply for this job: Director, Medical Affairs

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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