Sr. Clinical Document Processor Job
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Job ID: 13220
Location: Summit, NJ
Offsite Territory: Regular/Temporary:
Department: Clinical Central Services - 3630
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
H.S. diploma or equivalent required, college degree preferred; minimum 5-10 years formatting/word processing experience; Expert level Microsoft Word skills required with Microsoft certification desirable. Relevant experience preferred.
Responsibilities include, but are not limited to:
1. Develop, implement, and maintain tracking spreadsheet to collect, review, and report metrics.
2. Assist Document Processors with scheduling, organizing, and prioritizing the workload; negotiate timelines with customers as needed; resolve scheduling and resourcing challenges.
3. Create, maintain, and update customer guidance documents as needed.
4. Provide training to customers about Document Processing services and processes.
5. Make recommendations to management on procedural changes.
6. Demonstrate continuous effort to improve operations, decrease turnaround times and streamline work processes; work cooperatively and jointly to provide high quality customer service.
7. Assist in the implementation of expansion of services within Document Processing.
8. Train and serve as a mentor to others.
9. Use word processing and related software applications to format documents to the Celgene Style Guide specifications. Documents include, but are not limited to protocols, summary of changes (SOC), informed consent forms, clinical study reports, integrated summaries of safety and efficacy, clinical overviews, Investigator’s brochures, and briefing books.
10. Insert bookmarks and subsequent hyperlinks into documents (appendices and references) as well as cross references (tables, figures, section numbers).
11. Create summary of changes documents for protocols and Investigator brochures.
12. Establish and coordinate document workflows within an electronic document management system.
13. Conduct reference literature publication searches; order and format as required.
14. Coordinate and perform quality checks on Clinical Study Report Appendices.
15. Work with internal customers across the organization to initiate, revise and finalize time sensitive critical clinical documents.
16. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing standards.
17. Contribute to the ongoing development, maintenance, and enforcement of global Celgene standards as they relate to style, format, and electronic submissions.
18. Assist in the development of electronic templates.
19. Solicit and report customer feedback to contribute to continuous quality improvement.
20. Perform other related tasks as required and assigned.
- Minimum 5-10 years word processing experience with expert Microsoft Word, Excel, Outlook and PowerPoint skills
- Prior pharmaceutical industry experience preferred
- Project management experience and a proven track record of effective leadership preferred
- Experience with an electronic document management system including management of workflows and the review/approval process
- Must have strong interpersonal and communication skills to work in a team environment and across all levels of the organization
- Flexibility to meet shifting priorities and workload
- Must be able to work with limited day-to-day supervision
- Excellent written and oral communication skills required
- Excellent interpersonal and relationship building skills required
- Ability to prioritize and complete numerous tasks simultaneously under time constraints
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
Deadline: Contact employer
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