Patricia Barbiero

Current

• Clinical Submission Manager at Novartis Pharmaceuticals

Past

• Document Specialist at Novartis
• Sr. Administrative Assistant at Novartis

Education

• University of Phoenix
• Thomas More Institute
• University of Colorado at Colorado Springs

Recommended

4 people have recommended Patricia

Connections

44 connections

Industry

Pharmaceuticals

Websites

• My Company

Patricia Barbiero’s Summary

Clinical submission expert with extensive experience in clinical Health Authority registrations (New Drug Applications, Marketing Authorization Applications) and regulatory document requirements.

Provides outstanding capacity to interact with cross-functional departments and staff to drive and negotiate successful changes, create new processes, ensure fast and effective problem resolution.

Offers extensive knowledge of the technical and operational aspects of clinical registration activities and documentation management.

Utilizes understanding of the format and technical requirements that must be met to file New Drug Applications (NDA) with U.S. and international Health Authorities.

Demonstrates success coordinating the full documentation lifecycle and quality control review of all registration documents.

Patricia Barbiero’s Specialties:

project management, documentum, negotiation, regulatory requirements, health authority submissions, training, operations, quality assurance, quality control, NDA, sNDA, MAA

Patricia Barbiero’s Experience

• Clinical Submission Manager

  Novartis Pharmaceuticals

  (Public Company; 10,001 or more employees; NVS; Pharmaceuticals industry)

  May 2007 — Present (1 year 7 months)

  Plan, lead and coordinate activities, ensure adequate resourcing to support the timely preparation and execution of the clinical part of Health Authority (HA) Submissions. Ensure the timely delivery of high quality documents, as well as manage all logistical aspects of building a dossier.
  
  * Function as clinical submission expert and primary contact for clinical submission activities.
  * Lead the clinical submission teams with the Global Brand Medical Director.
  * Chair regular clinical submission team meetings.
  * Ensure appropriate clinical submission resource allocations.
  * Organize training of submission team members.
  * Develop, negotiate and track timelines, accountabilities and responsibilities for clinical components of submission.
  * Identify issues and resource gaps for the preparation and delivery of all clinical documents. Negotiate and implement solutions.
  * Organize quality control of all documents.
  * Contribute to improvement of submission processes and SOPs.

• Document Specialist

  Novartis

  (Public Company; 10,001 or more employees; NVS; Pharmaceuticals industry)

  February 2004 — May 2007 (3 years 4 months)

  Provided operational and technical expertise to cross-functional submission teams in all aspects of the registration document operations process.
  
  Identified and resolved problems to operational challenges by communication and negotiation with clinical and regulatory document publishing groups.
  
  Reviewed documents for technical compliance to internal and regulatory requirements and offered critical feedback to enable teams to meet tight deadlines.
  
  Defined, improved and documented processes for a timely delivery of documents, with efficient use of resources. Developed subject matter and conducted training for Clinical Trial Leaders and Managers.
  
  Significant contributor in delivering high quality clinical documents for over 15 global regulatory filings in the U.S. and Europe for Diovan, CoDiovan, Exforge, Tekturna, Galvus, and Lotrel.

• Sr. Administrative Assistant

  Novartis

  (Public Company; 10,001 or more employees; NVS; Pharmaceuticals industry)

  February 2002 — March 2004 (2 years 2 months)

  Responsible for international and domestic travel arrangements, calendar maintenance, expense reports, ordering office supplies and basic filing/typing duties with light telephones for two executives. Extensive use of MS Powerpoint to edit and create large business presentations, involving graphic design and complex charting. Researched statistics and other medical data through online medical journals to provide background information for charts and graphs used in presentations. Responsible for ensuring Novstyle compliance of clinical registration documents.

Additional Information

Patricia Barbiero’s Websites:

• My Company

Patricia Barbiero’s Groups:

Drug Information Association

•    Mineseeker Foundation
•    Pharmaceutical Professionals
•    Biotech & Pharma Professionals Network
•    Biotechnology/Pharmaceuticals

Patricia Barbiero’s Honors:

Oct 08: Novartis Pharma Development Business Excellence Award (individual)
Mar 07: Novartis Pharma Development Business Excellence Award (team)
Nov 06: Novartis Pharma Development Business Excellence Award (team)
Apr 06: Novartis Pharma R&D Business Excellence Award (individual)

Patricia Barbiero’s Contact Settings

Interested In:

• job inquiries
• expertise requests
• reference requests
• getting back in touch