Clinical Research Document Specialist III Job

Clinical Research Document Specialist III needed for a Contract opportunity with Yoh's client located in East Hanover, New Jersey.

The Big Picture - Top Skills You Should Possess:

- Electronic Document Management Systems
- Document Publishing

What You'll Be Doing:

- To publish and QC high quality scientific documentation (e.g. GCP, GLP and non-GLP study reports) for submission to regulatory authorities in support of marketing applications.
- Preparation of high quality scientific documentation and submission documents in accordance with the timelines specified by NIBR and in compliance to internal and external standards.
- Completion of an adequate number of nonclinical or clinical documents (taking into account complexity and size) per year in accordance with the timelines specified by organization KPIs.
- Published nonclinical or clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized.
- Timeliness of deliverables, such that both individual document and overall project timelines are met.
- Timely preparation of high quality scientific and summary documents to improve speed of preparation and quality of NIBR contributions to marketing applications

What You Need to Bring to the Table:

- 4 year degree required, preferably in a scientific field or related experience.
- At least 1-3 years experience with electronic document management systems, publishing tools.
- Basic knowledge of document publishing / document management including CoreDossier, Adobe Acrobat, ISI toolbox and / ISI publisher.
- Good oral and written communication skills.
- Basic experience in non-clinical and/or clinical report preparation and submission.
- Basic knowledge of regulatory requirements and pharmaceutical development.
- Basic knowledge of GxP and OECD requirements.
- Basic knowledge and compliance with the Good Laboratory Practices and Standard Operating Procedures.

What are you waiting for? Apply Now!

Recruiter: Corrin Pyle

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more !

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

J2W: CLINICAL; J2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2

Ref: 1065998

SFSF: LS