We are still growing strong.

 

For over 25 years, Novum Pharmaceutical Research Services has been a world leader in the conduct of clinical trials and equivalency studies for the generic, pharmaceutical, and biotechnology industries.

 

 Last year alone the FDA approved over 40 products for marketing where Novum had designed, conducted and reported the studies in the marketing application.  We have completed over 2,000 studies with over 36,000 participants for more than 200 pharmaceutical companies. 

 

Position Summary

Carries out various Quality Assurance and Regulatory Affairs activities.  These activities ensure compliance to company, client and regulatory agency requirements.

Responsibilities
·         Conducts audits of clinical research studies, statistical data, service providers and company operations to assess compliance to Standard Operating Procedures (SOP’s), study protocol, federal, state and local regulations and identify quality improvement opportunities.

·         Assists in hosting audits and inspections conducted by clients and regulatory agencies. 

·         Provides support for documentation control activities. 

·         Provides support for institutional review board management.

·         Provides good clinical practice (GCP) and SOP training.

·         Provides support for maintaining and acquiring non-personnel licenses.

·         Assists with review, updating and maintaining clinical SOPs.

·         Prioritizes day-to-day operations of the Quality Assurance Team.

·         Supervises QA Specialists I-II and Associates.

·         Assumes role of QA Management during absence for vacation/illness.

·        Bachelor's degree or equivalent , plus four or more years related experience in clinical 
          research or QA assurance in a similar field.
·         Related experience in pharmaceutical research preffered.
·         1-2 years management experience.
·         Auditing experience is required.
·         Knowledge of spreadsheet, internet and word processing software. 

Would you like to work for a company with small company values where everyone works as an integral part of the team to get the job done?  At Novum, our mission is to ensure excellence. 

We have a commitment to an ongoing learning process and professional development.  Our employees dedication to quality makes us what we are today. 

 

We take care of our employees.  Novum offers a very generous benefit program including: Health, dental, vision, dependant care and health flexible spending account, vacation, holiday and sick pay, short and long term disability, life insurance,  tuition assistance and 401(k). 

Please forward your cover letter, resume and salary requirements.  EEO