Subject Matter Expert (SME)

Coral Gables, FL

Posted: 06/12/2019 Employment Type: Direct Hire Industry: Pharmaceutical Job Number: 73082 Pay Rate: up to $150K

Our client, a growing global software company, is seeking an SME (Subject Matter Expert) who will provide expert, knowledge-based input to Sales, Marketing and Global Delivery teams in support of the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy. 

The primary function of this position is to bring customer facing, inward facing and industry / agency thought leadership experience to the company's drug safety offerings.


Some responsibilities include: 

Providing in-depth subject matter expert level knowledge of drug safety through three critical areas:


Customer facing: During discussions with potential customers, bring to bear extensive knowledge of the field, and explain not only how our products would suit them, but what they should be doing relating to drug safety, etc. Assist clients in overcoming the resistance in the industry to certain techniques, partly cultural and partly regulatory in origin and assist them in navigating through their concerns is an essential component.


Inward facing: Internally, this position will provide direction to help develop and design software tools so that they function appropriately. Working with different individuals involved, assist in the ongoing projects related to the safety suite as well as the creation of new offerings in the area of risk management. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support drug safety committees in their decision making. The SME will be responsible for identifying and maintaining relationships with development partners and monitor the development process of these strategic extensions.


Industry / agency thought leadership: This position will liaise with agencies on behalf of customers who might be particularly reserved about certain issues, and it is useful to be able to make thoughtful experienced arguments.  Though best practices in drug safety and pharmacovigilance, in many cases, don’t actually exist, customers are eager for knowledge about ‘how others do it right’. The SME will help establish these best practices. Prepares and delivers subject matter presentations, white papers, training, etc. 


Interested? Apply directly now or give us a call at (Dade: 305-595-3800 / Broward: 954-437-0070) Questions about this role or others? Email 


*CAREERXCHANGE® is an equal opportunity employer. We will present the most qualified candidates to our clients based on the skills required to perform the job. For additional opportunities please visit

  • Advanced degree required (Master's or PhD or MD in mathematics, medicine, drug safety, medical information, epidemiology, (bio)statistics, outcome measurement, health services utilization highly preferred)
  • 10 years of drug safety or epidemiology experience.  
  • At least 6 years in pharmaceutical medical research with at least 3 of those years spent in product safety/pharmacovigilance/benefit-risk optimization.
  • Experience with suitable training in Epidemiology (e.g., an MPH, Biostatistics degree) or a related discipline is preferred.
  • Pharmaceutical industry experience preferred.
  • Experience working with large administrative or medical records databases required; prefer candidates with current statistical programming expertise. 
  • Experience working with health authorities is preferred. The successful candidate will be expected to keep up to date with the FDA and other Regulatory Agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools. 
  • Global experience preferred.
  • Authored in the subject preferred.
  • Strong industry awareness (Life Science - pharmaceutical software).  
  • Proven ability to influence cross-functional teams effectively.   
  • Expertise in statistical software. 



Kevin Kerwin

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