Clinical Trials Label Coordinator - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Other
  • Experience:
    At least 3 year(s)
  • Date Posted:
    2/2/2018
  • Job ID:
    819515

Job Description


Job Summary

We are looking for a Clinical Trials Label Coordinator to join our Global Pharmaceutical company located in Summit, NJ. The ideal candidate will have a Life Sciences related Bachelor's degree - advanced degree preferred, and 1-3 years' experience in the pharmaceutical industry. This is a 6 month contract position, at 40 hours/week, with the possibility to extend or covert to permanent.

Responsibilities include, but are not limited to the following:

  • Develop an understanding of the clinical supply chain organization and its processes.
  • Interacts with global external vendors and cross functional support teams.
  • Responsible for completing specific tasks for assigned projects and studies.
  • May work on projects with peers from other departments or functions.
  • Ability to deliver under minimal supervision of projects with varying complexity.
  • Collation and archive approvals from different stakeholders and update the label text library database accordingly.
  • Executes to a pre-established timeline and project plan and is responsible for completion of specific milestones.
  • Mitigate issues and concerns to the label requestor.
  • Reviews GMP documentation for operational and technical accuracy.
  • Works with team members and supervisor to identify and resolve problems.
  • Develops internal cross-functional and external relationships. Manages issues and fosters teamwork.
  • Participates on cross-functional teams as necessary.
  • Coordinates the routing of draft label text and label proofs for translation and regulatory review and approval with Affiliates and CRO, Regulatory Affiliates, CMC.
  • Ensure documents are filed according to departmental processes.
  • Proactively communicates/escalates issues within the translation and approval process.
  • Build knowledge by supporting IMSC Operations in analyzing and processing labeling components.
  • Ensure compliance with Company SOPs and WPs and external procedures.
  • Being driven by a constant eye for quality.

Skills / Knowledge Required:

  • BA / BS
  • 1 – 3 years in Pharma industry related experience or equivalent experience
  • Experience in cGMP, cGLP, and ICH requirements.
  • Demonstrated skills in project management and handling multiple projects simultaneously.
  • Familiarity with legislative and regulatory requirements with respect to investigation of new drugs.
  • MS Office, Excel experience can be a novice (to enter data in cells).
  • SharePoint experience desired but will train if need be.
  • Basic knowledge of functional areas and drug development process.
  • Basic analytical skills, able to analyze information / situations.
  • Service oriented and ability to work under pressure.
  • **Please don't submit PhD candidates.

Competencies Required:

  • Teamwork and collaboration skills
  • Basic negotiation skills
  • Awareness of drug development process.
  • Basic analytical and influencing skills.
  • Basic project management skills.
  • Basic knowledge of industry technologies

For immediate consideration, please email resumes to: mbingham@apexlifesciences.com

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.