Regulatory Document Specialist Job

REGULATORY DOCUMENT SPECIALIST needed for a contract opportunity with Yoh's client located in East Hanover, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Document Management
- Regulatory Guidelines
- Oncology Clinical Trial Operations
- Investigator site procedures

WHAT YOU'LL BE DOING:

- Interacts closely with Oncology scientific personnel (Study Directors, Principal Scientists. Project Team Representatives) in the preparation/publishing of nonclinical and clinical study reports and regulatory documents, eg, INDs, CTAs, CTDs and reports of studies conducted by Oncology or contract laboratories.
- Preparation of templates for study reports and other regulatory documents, coordination of activities or processes within the Oncology business unit, activities associated with maintenance and use of the global DM&P document management system, archiving study or project related materials, participation on local or global teams and interactions with other line units, eg, DRA, on submission activities.
- Training of Oncology associates may also be an aspect of this position. These responsibilities require a working knowledge and compliance with the Good Laboratory Practices and Standard Operating Procedures.
- Preparation of reports and regulatory submissions.
- Maintain report distribution lists, report and protocol templates, coordinate global templates, and provide instruction to end-users.
- Assist on projects, as necessary.
- Participate on local and/or global teams.
- May have supervisory responsibilities (ie, direct reports and/or project-related supervision of other associates.).

WHAT YOU NEED TO BRING TO THE TABLE:

- Excellent oral and written communications skills.
- Experience in non-clinical and/or clinical report preparation and submission.
- Broad knowledge of general science.
- Working knowledge of IT systems, including experience in document management systems and/or publishing tools.
- Knowledge of company guidelines and regulatory guidelines for submission.
- Knowledge of Oncology clinical trial operations and Investigator site procedures.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Kara Lloyd

Yoh, a DayJ2W: SCIENTIFIC

MONJOBJ2WNECLIN

Ref:

SFSF: L