Regulatory Document Specialist

A Top 5 Pharmaceutical Company in Rahway, NJ is in need of 6 Contract Medical Program Document Specialists

They need this person to start in the next 2-3 weeks.

Job description:

Under the guidance of the Medical Program Documentation Specialist / TA Lead / Manager, this individual will assist in supporting the activities of the Medical Program Documentation Specialist function within the Operations Group for designated therapeutic area(s). The general focus of this Medical Program Documentation Group is to provide specialized support and assistance to Clinical Monitors and Medical Program Clinical
Specialists (MPCS) in the planning, execution and control of all clinical trial documentation. The functions of this group include but are not limited to: generating FDA 1572 forms, obtaining protocol signature pages and investigator CVs, preparing and negotiating an acceptable informed consent at the investigator site, managing IRB relationships, preparing regulatory packages for study start up, requesting and accounting for clinical study supplies, preparing, and compiling CSR appendices.

Some of the desired skills for this role include regulatory filings or audit experience and familiarity with regulatory and/or ICH guidelines.
REQUIREMENTS
Job requirements:

A bachelor's degree in any of the Life Sciences, Nursing and/or Pharmacy with experience in a research or healthcare setting.

1-3 years experience and/or equivalent competencies in pharmaceutical industry/clinical research including a working knowledge of the clinical/regulatory development process.
Excellent oral and written communication skills.
Good computer skills to assist with the data management / review.
Must be able to work effectively in both an independent and team environment.
Must be able to multitask.
Must possess effective time management skills.