Job Number: 19-07477
Job Number: 19-07477
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Document Publisher for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Independently manage CARA structure assembly, submission-readiness formatting, and publishing of Translational Medicine documents including validation reports, clinical study reports, Health Authority responses and clinical protocol supporting documents. Ensure PRISM compliance, and maintenance of model document report templates, as necessary
- Independently partner external authors for CARA structure assembly and document publishing of protocol and submission documents
- Mentor, train and provide troubleshooting assistance to internal TM personnel and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes
- Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents
- Independently manage submission readiness remediation, PRISM import and publishing of externally authored Word and PDF files
- Independently coordinate submission documents ensuring integration of scientific and regulatory input from team members
- Ensure that documents are received on-time, formatted and uploaded to CARA/PRISM within outlined critical timelines
- Ability to coordinate with third parties/vendors when necessary to retrieve required documentation
- Ability to work with various stakeholders across Client such as Biomarker Leads, Lab Scientists, Scientific Writers, TM Team leads, TMES and Document Publishing in order to gather needed reports for regulatory filings and/or responses to governing agencies
- Bachelor’s degree in science related field and 2+ years’ experience in project management and/or documentation filings
- Experience authoring with templates, tables and graphics
- Demonstrated experience managing multiple projects of significant complexity/global scope, in a highly virtualized team environment
- Experience and fluency with MS Office tools/desktop applications, (Microsoft Office, Adobe), core template and model document usage
- Knowledge of document management tools (documentum, PRISM/CARA), documentation standards and publishing work flows, a plus.
- Highly effective organizational and time management skills.
- Demonstrates strong communication (written and oral), interpersonal and negotiating skills.
- Works independently in a team setting and is flexible in a changing environment.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Sta Juana
Chris Sta Juana | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Job Status: Contract/Temporary