Regulatory Document Specialist Job

REGULATORY DOCUMENT SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Woodcliff Lake, NJ.

WHAT YOU'LL BE DOING:

- Review and approve daily Clinical Safety Alert Reporting (SUSAR, 6MLL, DSUR, IND Safety Alerts)
- Support the distribution of Safety Alert Reports to Investigators, Ethic Committees and CRO's per US and EU/ROW country-specific requirements
- Knowledge of databases (FirstDoc, eTMF, general Database Administration)
- Interact/collaborate with interdisciplinary groups such as Safety, Study Teams, and IT
- Generating monthly reports for inclusion on SharePoint site
- Perform daily document management activities such as proofreading, scanning, electronic and hard copy filing, uploading, and importing data and/or documents into relevant databases
- Accuracy of review is essential to ensure regulatory compliance.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree required
- Three to five (3-5) plus years Pharmaceutical experience
- Experience with guidance documents (SOPs/SWPs/Working Procedures, and User Manuals)
- Time Management skills required to meet time sensitive deadlines
- Proficient in MS Word, Excel, PowerPoint, Lotus Notes and Adobe Acrobat
- Must be detail oriented, highly organized, and quality driven
- Strong Communication Skills: Written and Verbal
- Strong proofreading, editing and reviewing skills are required
- Strong follow through skills are necessary
- Seeking someone who is a team-player, dependable, committed and has a strong work ethic
- Ability to provide exemplary customer support for our internal management, and staff, as well as to our external clients and vendors
- Must be able to work independently and possess problem solving skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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