biopharmaceutics Associate

Research & Development Philadelphia, Pennsylvania


Description

Summary

The Biopharmaceutics Associate is responsible for coordination of requirements to conduct clinical studies with Clinical Research Organizations CRO. This position is the point of contact to coordinate between Lannett, the study Sponsor, and external CRO’s conducting clinical trials on Lannett’s behalf.

 

Essential Duties and Responsibilities (Including, but not limited to, the following list.  Management retains the discretion to add or change job duties at any time.)

  • Coordinate between internal legal department and external CRO execution of Master Service Agreements and Service Contract for clinical studies.
  • Coordinate alignment on the final clinical study protocol for execution.
  • Coordinate documentation transfer to CRO for any specific requirements by Regulatory authorities or an Internal Review Board to conduct studies.
  • Coordinate obtaining any reference products required by CRO.
  • Coordinate clinical supply release and shipping and ensure chain of custody is maintained.
  • Coordinate obtaining final study report in FDA’s current format and providing to the Regulatory department. This includes reviewing all final documents for errors and discrepancies.
  • Coordinate clinical study sample retention for all bioanalytical samples
  • Maintain and archive all documents according to SOP’s.
  • Write and update SOP’s as required.
  • Other duties as assigned

 

Essential Skills:

The Biopharmaceutics Associate must be highly organized with strong, analytical, research, literature search, reference library/document management, math, and statistical skills. They should be good problem solvers with a solid understanding of scientific data collection and management methods. Solid verbal and written communication skills are necessary, as is the ability to interact with healthcare professionals, researchers, internal functional areas,  external CRO’s, understanding of GMP. GLP, cQUA and ICH guidelines and regulations, and a team player. Computer skills and proficiency with Excel, MS Word and PowerPoint, spreadsheets, and databases used for tracking are essential. Familiarity with WinNonlin and graphing software would be considered as plus.

Relationship:

This position provides communication that facilitates interactions with both internal functional areas and external CRO’s. This position must interact with all departments necessary for the development of products.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Must be able to pass a company paid background check to handle controlled substances.  Must have verbal and written command of the English Language.  A wide degree of creativity and latitude is expected.  The desired candidate will have a Pharm. D. degree (preferred) with 0 to 5 years of experience, nursing degree with 5+ years of experience in clinical trial management, B.S/B.A. degree in a physical science (Chemistry, Biology, Biochemistry preferred) with 3+ years of experience in clinical trial management.