(Document) Specialist I, Clinical Pharmacology
Other Locations:US- NJ- Summit WestSummary/Scope:
The Document Specialist I interfaces with the Trial Managers, Pharmacologists, and Pharmacokineticists to perform the QC, formatting, publishing and eSub maintenance of all TD-CP documents. - As part of the Clinical Pharmacology Operations team the incumbent is expected to require moderate supervision. He/She will work together, cultivate open communication and utilize knowledge and skills to partner with clinical stakeholders. This person will provide premium quality operation in all aspects of translational development and clinical pharmacology projects.
Responsibilities will include, but are not limited to, the following:
1. Provides QC, formatting and publishing support to Translational Development- Clinical Pharmacology, including the Trial Managers, Pharmacologists, and Pharmacokineticists.
2. Responsible for the QC of all documents written in TD-CP which include protocols, protocol amendments, investigator brochures, clinical study reports, bioanalytical reports and submission documents such as INDs and NDAs for submission to health authorities for quality, correct grammar, spelling, accuracy, and consistency.
3. Conducts QA/QC reviews of bookmarks and hyperlinks.
4. Reviews document content for accuracy, completeness and consistency against source documents and source data.
5. Provides formatting of text and tables for all documents written in TD-CP which include protocols, protocol amendments, investigator brochures, clinical study reports, bioanalytical reports and submission documents to ensure adherence to Celgene style guide.
6. Communicates changes in the documents described above to authors, including CRO personnel in an effective manner when applicable.
7. Provides instruction and guidance on templates, formatting and publishing to CROs in accordance to the Celgene style guide.
8. Interacts with various departments for Document Quality (eg. Regulatory Operations and Clinical Quality Assurance).
9. Liaises with the Regulatory Operations department to maintain TD-CP electronic document repository, assists authors with initiating workflow's, takes part in the review and approval process of protocols and clinical study reports to meet all eSubmission requirements per Celgene policy.
10. Works with Clinical Quality Assurance department to initiate and maintain SOP and WP training to department to ensure compliance.
11. Assists in the development and tracking of new departmental forms, templates, standard operating procedures (SOPs), working procedures (WPs) and guidances. Supports TD-CP personnel as needed for report management and provides electronic submission training and troubleshooting as needed. Assists with the compilation of the monthly report for Clinical Pharmacology.
- Bachelors Degree / Life Sciences or related field and 4 years related experience OR Masters Degree / Life Sciences or related field and 3 years related experience
- Basic knowledge of document management
- Basic knowledge of clinical development process
- Basic knowledge of GCP/ICH guidelines - Basic knowledge of computer applications including document management systems such - Documentum or eSubmission preferred
- Able to follow SOPs/WPs - Basic knowledge of SOPs/WPs and templates, and contributes to writing of these documents
- Basic knowledge of document formatting/editing/publishing techniques/tools such as ISI Toolbox and all of its features (eg. creating bookmarks and hyperlinks, using the auditor)
- Able to multi-task and prioritize with moderate guidance
- Detail-oriented - Excellent written and oral communication skills required. - Must be able to work with moderate supervision and coaching on projects
- Candidate should demonstrate creative thinking as it relates to identifying/recognizing issues and recommending solutions to problems.
- Ability to escalate higher level issues/ problems to appropriate individuals is desirable.
- Must possess strong interpersonal and communication skills, be a team player and be willing to work in a fast-paced environment, where changing project priorities and work assignments require flexibility.
- Strong PC experience, Microsoft Office Suite experience required including Microsoft Word; Excel; Outlook; PowerPoint and strong computer acumen.