Tara Dougherty, Ms

Multi-Faceted and Hard Working Business Services Professional

Summary

Accomplished, self-motivated, and teamwork oriented Regulatory Affairs  and Business Services Professional with an accumulated 7 plus years of Pharmaceutical and Biotechnology industry experience. Expertise in regulatory submissions to the FDA in eCTD format. Working experience in Regulatory Affairs, Regulatory Operations, Clinical Research & Development, and Quality Assurance developing small molecule drugs, large molecule biologic products and combination biologic/device products.

Work History

Work History
Jun 2013 - Aug 2015

Senior Associate, Regulatory Affairs

Accenture

Recognized by Regulatory Affairs leaders for going above and beyond to help the team meet their submission deadlines. Management of the content and quality review of electronic submission of IND and NDA lifecycle management submissions, such as Annual Reports, Safety Reports, CMC Amendments. Expertise at reviewing Clinical Submissions, such as New Protocol, New Investigator and Protocol Amendment type submissions in electronic submission format. Manage multiple regulatory submission projects for multiple clients while meeting or exceeding submission deadlines. Review of eCTD backbone file structure using eCTD Viewer to make sure the documents are in the correct location and are ready to be viewed by regulatory agencies.

Apr 2008 - Jul 2009

Patient Informed Consent Specialist

ClinForce, LLC
Nov 2007 - Jan 2008

Regulatory Specialist

INC Research
REGULATORY SPECIALIST New Hope, PA Analyzed client clinical trial goals providing expert accelerated regulatory approval pathways. Persuaded clientèle to migrate from paper trial master files to an eTMF Documentum based storage saving the need to store paper in an archive room. Tracked trial progress in anticipation of planned start and completion dates to ensure client objectives were met. Coordinated, prepared and reviewed investigator documentation for submission to central Investigational Review Boards and regulatory binders for local site investigators.
Apr 2006 - Aug 2007

Document Control Specialist

Tengion
DOCUMENT CONTROL SPECIALIST Malvern, PA Researched, presented and helped to implement an EDMS software program for both electronic and paper document control system which created inspection readiness and reduced change control timeliness. Advised senior management of documentation issues and provided practical solutions to remain in compliance with cGMP regulations and Good Document Practices guidelines. Reviewed Manufacturing and Quality Assurance documents such as Standard Operating Procedures, Quality Control specifications, test methods, protocols and batch records for format and compliance to internal company standards and external documentation guidelines. Received an annual bonus due to exceptional performance and dedication in meeting company objectives and departmental expectations.
Jan 2006 - Apr 2006

Regulatory Document Associate

Aerotek
REGULATORY DOCUMENT ASSOCIATE Contracted to Cephalon West Chester, PA
Jan 2005 - Mar 2006

Archivist

GLOBAL REGULATORY
ARCHIVIST Contracted to, a J&J Company Malvern, PA

Education

Education
2009

M.Sc

TEMPLE UNIVERSITY
2004

B.Sc

WEST CHESTER UNIVERSITY

Skills

Skills
7
Client Relationships 

Experienced at developing relationships with clients and building trust to give them professional advice. 

7
Regulatory Submissions 

Filing of Investigational New Drug applications to the US FDA.  Experience with submitting to CDER and CBER divisions.  

10
Document Management Software 

End user of Documntym and Qumas DocCompliance software.  Managed clinical trial documentation electronically using document storage software.