Newark Metro Area, New Jersey
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 in accordance with the style guide.
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.
10. Able to demonstrate and promote Values and behaviors.
- 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.
- Strong organization and interpersonal skills, be detail-oriented, be a team player and be willing Work in an environment where individual initiative and accountability to projects are required.
- Work with limited day-to-day supervision.
- General knowledge of SOP standards, and be able to follow SOPs/WPs.
- Basic knowledge of computer applications 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 if its features (for example, creating bookmarks and hyperlinks).
- Bachelors Degree / Life Sciences or related field, or equivalent in industry experience.
- Minimum 3 years document management experience.
- Minimum 3 years experience in the Pharmaceutical industry.
- Strong PC skills to include: Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).