Labeling Project Coordinator - II in Santa Monica, CA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  1021565



Description: We are seeking a Clinical Labeling Coordinator to be a hardworking leader that encourages teams while providing technical expertise in a dynamic pharmaceutical clinical labeling environment for global clinical trials.
The Clinical Labeling Coordinator works collaboratively with other members of Clinical Labeling, Quality, Clinical Operations, Package Engineering, Supply Chain, Regulatory and Project Management staff to meet project deliverables.
Specific Job Requirements:
  • Responsible for processing clinical labeling documents and completing activities associated with multiple clinical development programs. These include but are not limited to label generation and approval per regulatory guidelines.
  • Interacts with internal cross-functional teams to provide input into labeling options.
  • Engages the clinical labeling group to meet company goals including department improvement projects.
  • Works closely with ancillary groups to process and approve GMP documents
  • Authors and reviews documents to ensure GMP compliance.
  • Responsible for change control task closures and preliminary assessments.
  • May participate in other Clinical Supply chain roles.

Knowledge:
  • Excellent verbal, written, and social communication skills are required.
  • Strong computer and organizational skills required.
  • Project and document management experience a plus.
  • Experience with Change Control is beneficial.
  • Able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
  • Ability to write clear, concise and error-free documents.
  • Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action.
  • Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13.
  • Prior experience with clinical labeling, including the technical aspects of label design, is preferred
  • Requires a Bachelor's degree and a minimum 2 years of relevant industry experience preferably in clinical labeling or regulatory roles

For immediate consideration please send your most recent resume to bnguyen@apexsystems.com
 
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178.