Medical Safety Reviewer

Chiltern International is a well established global contract research organization with offices throughout Europe, North America and India.  We were established in 1982 and have served pharmaceutical, biotechnology, and device companies in over 38 countries worldwide.  Due to our continued growth, Chiltern is seeking a highly motivated individual to join us as a Medical Safety Reviewer.  Candidates can be located in the Alameda, CA area.

 

The position will start off P/T ~10-15 hrs per week, and will increase from there. Other than the weekly staff meetings for about 1 hour and when needed for the clinical studies, most work can be completed from home.

 

The qualified candidate will:



· MD degree required

· Board certified Endocrinologist preferred

· Specialty training and clinical experience in Diabetes preferred

· Clinical development experience in a Biotechnology, pharmaceutical, or CRO preferred

· Expertise in clinical trial design and related statistical experience preferred

· Knowledge of FDA regulations preferred

· Excellent verbal and written skills

· Excellent presentation skills preferred

· Strong computer skills preferred



 

Essential job functions include:

· Serves as the Principal Investigator for Abbott’s internal clinical studies and Medical Monitor for external trials (where appropriate) focused on ensuring trial subject safety, compliance and Adverse Event evaluation.

· Serves as a source of medical expertise for the diabetes clinical project teams

· Provides medical input for the design, planning, initiation, and execution of clinical trials

· Responsible for the medical and scientific components of study protocols, IDEs and other regulatory submissions

· Provides input into decisions that have medical, scientific, and commercial implications

· Provides input with strategic intent when working with regulatory agencies and KOLs

· Performs product safety monitoring and medical reviews for assigned investigational products

· Writes articles and/or abstracts for publication or presentation at conferences



 

 

Primary Function/ Primary Goals/ Objectives:

Provide medical experience, oversight and input for our Diabetes clinical development programs.  This person will provide medical and scientific guidance and oversight for clinical aspects of product development including principal investigator for internal trials, protocol design, medical monitoring, clinical trial site recruitment, data interpretation, adverse event evaluation and reporting.  This person could also support regulatory submissions including IDEs, Premarket Approvals (PMAs) and 510(k) from a medical perspective

 

Chiltern’s unique corporate culture encourages a healthy balance of personal life and work.  We offer an excellent salary and benefit package to include medical, dental, vision, company matching 401K, excellent vacation & holiday, paid life insurance, AD&D, long and short term disability and many other employee incentives.  If you have the experience required and feel you are the dynamic person we are looking for, please forward your resume in a Word document via email to:  uscareers@chiltern.com