Documentation Specialist - Clinical Pharmacology in Summit, NJ at Apex Life Sciences

Date Posted: 8/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/30/2018
  • Job ID:
    872071

Job Description


Documentation Specialist – Clinical Pharmacology

Responsibilities:

  1. Support Clinical Pharmacology trial managers, pharmacologists, and pharmacokineticists by performing the Quality Control (QC), formatting, and publishing/maintenance of key documents (for example: protocols, clinical study reports, manuscripts, investigator brochures)
  2. Conducts QA/QC reviews of bookmarks and hyperlinks
  3. Reviews document content for accuracy, completeness and consistency against source documents/data
  4. Provides formatting of text and tables for documents authored by Clinical Pharmacology
  5. Communicates changes in the documents described above to authors, including CRO personnel, in an effective manner
  6. Provides instruction and guidance on templates, formatting, and publishing to CROs
  7. Interacts with various departments focusing on document quality (for example: Regulatory Operations and Clinical Quality Assurance)
  8. Supports Clinical Pharmacology personnel, as needed, for report management and provides electronic submission training and troubleshooting when necessary
  9. Assists with compilation of monthly report for Clinical Pharmacology

Skills/Knowledge Required:

  • Basic knowledge of document management/quality control, including strong familiarity with clinical documents (for example: protocols, clinical study reports, ICFs, manuscripts)
  • Basic knowledge of clinical development and ICH/GCP preferred
  • General knowledge of SOP standards, and must be able to follow SOPs/WPs
  • Basic knowledge of computer application including electronic document management systems such as Documentum or eSubmission
  • Basic knowledge of document formatting, editing, publishing techniques, tools such as ISI Toolbox and all of its features (for example: creating bookmarks and hyperlinks)

Qualifications

  • Bachelor’s Degree / Life Sciences or related field, OR equivalent in industry experience
  • Minimum 3 years in document management experience
  • Minimum 3 years in the Pharmaceutical industry preferred
  • Strong PC skills: Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)

FOR IMMEDIATE CONSIDERATION please email your resume to grucci@apexlifesciences.com or call 732-636-1497 

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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 844-463-6178.

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 844-463-6178.




872071