Quality Control Manager

Paul Scott Kirkpatrick

Home - 610-***-****

Cell – 484-***-****

E-mail – **********@*****.***

EDUCATION

• Delaware County Community College. Associate’s Degree; Business Admin. Media, PA, 19063

• Villanova University. Bachelor of Science, Business Administration. Villanova, PA 19085

TOOLS/TECHNOLOGIES

• NWAES

• DEOIS

• ARGUS

• MS Word, Excel

• Intralinks

• Compose

• ISI

• Adobe Acrobat

• Right Track II

• EIIP

• Regulatory Document Tracker

• Documentum

• IMPACT

• DIRM

PROFESSIONAL EXPERIENCE

Merck and Company

January 2012 – July 2013

West Point, PA 19486

Adverse Events Coordinator

• Registration of Adverse Event Reports into the worldwide safety database.

• Responsible for follow-up reports, returned correspondence, memos, telephone reports.

• Responsible for sending out company correspondence on Adverse Events to patients and HCPs.

• Software programs used were NWAES, DEOIS, and ARGUS.

GSK

September 2010 – December 2011

Collegeville, PA 19426

Clinical Studies Associate

• Responsibilities include the reviewing of required regulatory, financial and legal documents from

study sites for quality and accuracy.

• Tracking the receipt of regulatory documents from study sites and submit to appropriate departments

for approval of drug shipment.

• Interact with the sites through Intralinks to resolve regulatory and financial document discrepancies.

• Maintain study/site information in database systems such as Intralinks and Excel Spreadsheets.

ViroPharma

December 2008 – August 2010

Exton, PA 19341

Regulatory Operations Associate

• Prepare and publish regulatory submissions, in both paper and electronic format.

• Organize and oversee quality checks and proofing of all submissions upon completion.

• Receive, track, maintain, distribute, and archive various clinical documents.

• Collaborate with other functional areas such as QA and CMC, as well as outside consultants and

vendors to establish processes and timelines of pertinent documents in various types of submissions

such as NDA. IND, and BLA for the US, NDS and CTA for Canada, and MAA for the EU.

• Knowledge of industry standards for desktop publishing of regulatory submission documents,

including Case Report Forms to eCTD readiness.

• Using PDF publishing tools such as Compose, ISI and Adobe Acrobat tools for scanning, masking,

paginating, deleting, inserting, saving, bookmarking, hyperlinking, and archiving electronic

documents for submissions.

• Documentum used for checking out and editing documents for archive purposes.

Merck and Company

West Point, PA 19486

February 2007 – December 2008

Adverse Experience Registrar

• Registration of Adverse Event Reports into the worldwide safety database for both incoming

investigational and marketed products in accordance with company policies and procedures.

• Responsible for follow-up reports, returned correspondence, memos, telephone reports, B-Forms and

the identification of duplicate reports by searching the safety database.

• Software programs used were DEOIS and NWAES.

ICON Clinical Research

January 2006 – February 2007

North Wales, PA 19454

Clinical Studies Associate

• Assisting in study start-ups and maintenance of INDs for Clinical Trial Studies for Pfizer.

• Updating sponsor software systems Right Track II, EIIP, Regulatory Document Tracker, Excel

spreadsheets and other systems in order to initiate, review, send out, track, and archive Regulatory

Documents for these studies.

• Primary point of contact with the various study sites on 30 protocols, with more than 300 sites.

Involved in Drug Release and Continuing Reviews for Annual re-approvals, and 1572 revisions, CVs,

Financial Disclosure Forms, and other regulatory documents for each study.

• Some reviewing of Informed Consent Documents.

Wyeth Pharmaceuticals

May 2005 – January 2006

Collegeville, PA 19426

Clinical Trial Support Specialist

• Responsible for supporting Clinical Trials by executing specific trial operations tasks.

• Supported the Clinical Trial Manager in study start-up and site management responsibilities.

• Primary point of contact for in-coming site communications.

• Support the CTM in out-going site communications.

• Track IRB approvals, contract issues, site initiation, and all documents required for site start-up.

• Data input of site information into IMPACT.

• Check that study documents are correctly filed in EDMS.

AstraZeneca

October 2004 - April 2005

Wilmington, DE 19850

Clinical Research Associate

• Assisting the clinical study team in the startup, execution and close-out of clinical trial studies.

• Archiving, auditing, track investigator selection activities/regulatory documents/non-regulatory

documents, assist in management of clinical supplies, data management, and study file maintenance.

• In-house company software packages of IMPACT, DIRM, and Excel Spreadsheets

Centocor

January 2003 – September 2004

Malvern, PA 19355

Submissions Coordinator for Regulatory Affairs

• Preparing, saving, and mailing documents of Safety Reports such as Adverse Events and Clinical

Trial Studies, Protocol Amendments of New Investigators, and Annual Reports to the FDA and other

Health Authorities worldwide.

• Doing Quality Control on submissions before they are sent to the Health Authorities. Using Compose,

ISI and Adobe Acrobat tools for scanning, masking, paginating, deleting, inserting, saving, and

archiving the submissions in Documentum.

PROFESSIONAL REFERENCES:

Viropharma

Rob Connelly – Director, Regulatory Operations – 610-***-****

Greg May – Senior Regulatory Affairs Specialist – 610-***-****

Amy Grant - Director, Regulatory Strategy & Science – 610-***-****

Merck and Company

Paulette Castella – Assoc. Dir., Drug Safety – 215-***-****

Filippa G. Karcewski – Assoc. Dir., Dug Safety – 215-***-****

Patricia Kolonis – Specialist, Drug Safety – 215-***-****

Carolyn Ward – Specialist, Drug Safety – 215-***-****

GSK

Kimberly Rath – Lead Clinical Study Associate – 610-***-****

Jeanne Purtell – Lead Clinical Study Associate – 610-***-****

ICON Clinical

Tammy Masiado – Director of SSU – 215-***-****

Teri Seiders – Clinical Study Associate – 215-***-**** (cell)

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