Labeling Associate - clinical packaging in Lansdale, PA at Apex Life Sciences

Date Posted: 2/9/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a highly motivated Associate to support clinical supply label production for a top Pharmaceutical company. 

Responsibilities

  • Coordination of Label Translation Requests
  • Generation of Clinical Label Proofs
  • Liaise with country-level Clinical Operations personnel or Regulatory Affairs to request and revise translations, address questions, update regulatory requirements, etc.
  • Maintain Label Translations library
  • Interpret clinical study designs and Clinical Supplies Specification documentation
  • Understand and maintain study blinding
  • Coordinate booklet label manufacturing at vendors
  • Perform visual inspection and accountability for label proofs
  • Collaborate with partners and stakeholders within the Clinical Supply Chain

Qualifications:

  • Bachelor's degree (BA/BS), preferably in Sciences
  • 3+ years of pharmaceutical industry experience desired
  • Working knowledge of clinical packaging operations including the understanding that all clinical supplies and associated documentation are processed according to Standard Operating Procedures, study protocols, GMPs/GDPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies. 
  • Proficient with Microsoft Office applications.
  • Demonstrate excellent attention to detail
  • Demonstrate strong communication and interpersonal skills to work in team environment
  • Demonstrate excellent oral and written communication skills
  • Provide detailed analysis of issues and collaborate for creative problem solving

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.