Sr Submissions Coordinator

Novartis Institutes for BioMedical Research, Inc.

Location: Morristown, New Jersey-Central 07960
Posted on: 10/5/2009 10:12:04 AM
Postion type: Full time
Job Code: 1705296HHL
Required Education: Bachelor's Degree
Salary: Competitive

DESCRIPTION

*This position can be located in either Basel or East Hanover, NJ.

This role will provide strategic and operational expertise to the timing and quality coordination/oversight of Translational Sciences (TS) components of Health Authority Submissions. Provide advice and training to preclinical authors and PTRs.

1. Function as the submission expert for TS for INDs, IMPDs or CTAs, CTDs and Health Authority responses.

2. Work with Expert submission coordinator to ensure that TS submission teams are trained to put together the submission (e.g. on time Novstyle, CREDI/PREDI, regulatory requirement training).

3. Develop and track timelines for TS components of submission by partnering with TS PTMs, functions within TS (TM, BMD, PCS, DMPK, TS Documentation), DRA Submis-sion Leader, and CD&MA submission coordinator.

4. Assure the timely import of TS documents into CREDI and PREDI.

5. Assist with final QC of TS portion of submission, deliverables and ensure final sign off is completed in TS.

6. Identify issues with the TS portion of the submission as well as resource needs. Nego-tiate and implement solutions.

7. Communicate status reports to TS Core PTR, LF management and Submission Leader.

8. Partner with DRA Submission Operations Leader for problem solving, proper representa-tion at global tracking meetings and internal observance of the agreed upon timelines.

9. Collaborate with TS scientific publishing personnel in the planning, preparation, QC and publishing of nonclinical and clinical study reports and regulatory documents required for submissions.

10. Maintain advanced knowledge of current electronic submission standards, regulatory guidelines and legal requirements.

11. Train project teams and / or line functions on 'submission readiness' requirements for submission components.Ideal Background

Education (minimum/desirable): Minimum: bachelors degree with experience equivalent to graduate degree

Desirable: University degree (Diploma, Masters or Doc-toral in life sciences, chemistry, business admin)

Languages: English fluent (oral and written)

Experience/Professional requirement: * 3 years experience in Clinical Pharmacology, or Toxi-cology, or Preclinical Safety, or in any other TS dis-cipline

* Advanced knowledge of CTD requirements

* Advanced knowledge of internal submission require-ments and external regulatory requirements.

* Advanced knowledge of CREDI and PREDI

* Advanced knowledge of GXPs

* Prior submission experience

* Ability to lead multidisciplinary teams

* Advanced knowledge in all aspects of drug develop-ment

* Excellent oral and written communication skills

* Advanced knowledge of regulatory requirements and pharmaceutical development

* Working knowledge and compliance with the Good Laboratory Practices and Standard Operating Proce-dures

* Excellent organizational skills and advanced team-work skills with customer focus emphasis.

* Strong willingness and aptitude for learning and adapting new information and innovations

REQUIREMENTS:
See Job Description Label