Innovations technological

Hi I have an urgent requirement of 'Regulatory Document Specialist' please send me your resumes along with your contact details.

Position : Regulatory Document Specialist

LOCATION:    Tarrytown, NY

DURATION:   6 months+

INTERVIEW:   phone screen; face-to-face

START DATE:  9/9/13

RATE - $40

CITIZENSHIP: Must be USC/GC

Education Level:     Bachelor's Degree

Years Experience:    3-5 Years

REQ. SKILLS:    Regulatory Document Specialist

DESIRED SKILLS AND EXPERIENCE

GXP Compliance:             GCP

Position Summary:         Responsible for independently formatting and publishing electronic documents for Regulatory submissions.  Integrates and applies strong knowledge of US electronic regulatory submission requirements in support of ongoing drug development programs. Requires some guidance from direct manager.

Essential Functions of the Job (Major Duties and Responsibilities):       

-Independently formats and publishes electronic Regulatory submission documents and ensures quality, accuracy, and submission readiness per Regulatory agency guidance and specifications. Will QC others work.

-Develops and maintains document formatting and publishing procedures and standards for regulatory submissions. Assists with training staff on procedures and standards.

-Provides guidance to multidisciplinary teams on format, style, and architecture of electronic compliant documents for INDs, BLAs, MAAs, annual reports, amendments, supplements, or variations in accordance with title 21 CFR and all FDA, EU and ICH guidelines.

-Assists with providing StartingPoint eCTD authoring template training.

-Maintains Regulatory archives

-Provides support and backup to management as needed.

Other Duties and Responsibilities (Secondary to the Essential Functions of the Job):    

Other:   Requires knowledge of title 21CFR and all FDA and ICH guidelines. Prior regulatory document and electronic document publishing experience required.  Experience with EU or other international submissions guidelines desired.

Required Skills:                Works independently; strong technical, organizational, and communication skills; strategic and critical thinking; specialized expertise in formatting and publishing documents

Required Special Equipment and/or Programs: Advanced proficiency in use of Microsoft Word, Adobe Acrobat, and electronic document management systems (NextDocs preferred) are required. Working knowledge of SharePoint, StartingPoint, ISIToolbox, A-Pulse are preferred.       

Thanks and Regards

Andy

Talent Acquisition Team  Glomark International LLC Direct: 908-333-5191 Fax: 908-688-8831 Email: andy@glomark-llc.com / Gtalk: glomarkandy@gmail.com