Training Sales

Annmarie J. Harris

PROFESSIONAL QUALIFICATIONS

• Extremely organized, excellent communication and interpersonal skills, highly

motivated, flexible, multidisciplinary and multilingual professional

• Working knowledge of MS Word, Outlook, Power Point, Documentum, and LIMS

• Fluent in Spanish

PROFESSIONAL EXPERIENCE

GLOBAL PHARMA SOURCING, West Chester PA

9/2010 – 12/2012 - Regulatory Affairs Consultant

• Performs necessary responsibilities as dictated by client

• Provides world-wide regulatory guidance

• Dossier writing and review

• Provides templates for CMC sections

• Sales and Marketing of drug substance and product in Spanish speaking countries

LONZA INC., Conshohocken, PA

3/2007 TO 12/2009 - Regulatory Affairs/GMP Specialist & QA Inspector of Warehouses

• Part of Lonza Riverside Management Team

• Provides all regulatory support for QA and QC

• Researches, Creates and Publishes all DMFs for APIs and Intermediates in US,

Japan, EU and ROW

• Implements regulatory strategy and intelligence for multiple clients

• Handling of deficiency letters and other correspondence received from the FDA

and other world agencies regarding submissions

• US Agent for EU drug establishment registration

• Responsible for closing DMFs

• Writes Annual Product Reviews for APIs and Intermediates

• Writes Annual Reports and amendments for DMFs

• Responsible for site registration process through FDA

• Core member of the Change Control Committee

• Maintains Site Master File

• Assisted in writing a global SOP for DMF submissions for Lonza Inc.

• Wrote SOP for Drug Master File creation process

• Leads meetings and communication with multiple world-wide clients

• Training of temporary staff to fulfill assigned tasks

• Daily inspection of warehouses

• Daily review of data from cold storage (Dickson software)

• Inspection of products for release to ship

• Inspection of incoming raw materials

• Wrote the Sop’s and Procedure for Annual Product Review

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• Wrote and devised a procedure for Gap analysis of all DMFs internally and

externally with the customer filings.

• Batch record review

• Administering of various on-site trainings

Lonza Technical Training

• Lonza Careful Communication Training

• Lonza Code of Conduct Training

• GMP Training

• Working Words Investigative Report Writing

• Center for Professional Advancement REACH intensive short course

• Internal Lonza World-wide Regulatory Meeting Visp, Switzerland 2008

• Expert Briefings Seminar eCTD structure and format

• CfPA CMC submissions in CTD format August 4 – 5th, 2008.

• Lonza train the trainer training course March 2008

• Drug Master Files – Understanding and Meeting Your Regulatory

and Processing Responsibilities April 2009

• FDA SPL Release Training Session – Preparing Electronic Drug Establishment

Registration and Drug Listing Submissions June 11, 2009

• FDA SPL Release Training Session – Establishment Registration –

Domestic Establishments June 18, 2009

CRITICAL PATH SERVICES LLC, Wilmington, DE

9/2006 TO 2/2007

DUPONT AGRICULTURE, Newark, DE

Dossier Coordinator

• Use of Documentum

• Create folders for dossier documents

• Format, edit, and revise scientific papers for dossiers

• Generate, build and maintain tracking spreadsheets

• Use mail merge to insert reference lists and quality checks into dossier

• Familiarity with EU Rev. 8 and OECD data points for dossiers

DEGRAFT-JOHNSON & ASSOCIATES LLC, Boothwyn, PA

8/2003 TO 8/2006 - Senior Consulting Manager, Regulatory/Business Development

• Provided regulatory support

• Assisted in preparing regulatory submissions (INDs, DMFs, European DMFs,

Veterinary DMFs/ASMFs, Certificate of Suitability,MAA variations, NDA Amendments,

Clinical Trial Applications etc) with and without use of the CTD format

• Technical writing/Translation of business literature and Live client interface translation

• Performed pertinent research for all aspects of projects including review of

clinical trial data

• Implemented regulatory intelligence

• Provided business development and marketing expertise

• Patent searches

Elkton, MD 484-***-**** cell ***********@*****.***

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• FOIA searches

• Prepared proposals for CROs

• Attended FDA agency meetings to take scientific notes

• Training course preparation and administration

• Performed project planning and scheduling

• Prepared RFPs

• Website Building/Editing

• Business brochure design

• Cultivated business opportunities for DJA at appropriate conferences/Trainings

• Attended Eino Nelson Conference FMC 2005 Coral Gables FL,

SOCMA/Informex 2005 Las Vegas NV, DIA Annual Conference 2005

Washington D.C., CPhI 2005 Madrid Spain, SOCMA/Informex 2006 Orlando FL

WYETH PHARMACEUTICALS, Collegeville PA

9/13/05 TO 10/27/05

• Consultant Services provided

• MAA variation submission preparation Types I and II

• Technical writing of expert reports

DEGRAFT-JOHNSON & ASSOCIATES LLC - Technical Training

• US Regulatory Affairs Parts I & II

• Drug Product Challenges-A Scientific & Regulatory Overview

• Generic Applications in the EU after Review 2001

• ICH CTD Guidelines and Current Status of Implementation

• A Look at Today’s Drug Development Outsourcing Practices: Successes,

Failings and Ways to Improve Them

• eCTDs: Regional Progress and Lessons Learned from the Regulatory Authority Perspective

• eCTDs: Case Studies

• Drug vs. Device Clinical Trials & Now the Combination

• eINDs

• Regulation of Clinical Research in the EU: Impact of the Clinical Trials Directive

• European Clinical Trials Directive Implementation: An Actual Status

• Clinical Trials in Latin America: A Review of the Regulatory Framework

• Delaware County Chamber of Commerce Course: How to Build Business Credit

• RAPS Course: In Vitro Diagnostics (IVDs)

• Delaware County Chamber of Commerce Course: How to Finance Your Small business

FISHER SCIENTIFIC, Norristown, PA

4/2002 TO 1/2003 - Life Science/Chemistry Conversion Specialist

• Coordinated chemistry and biology information from various vendors

• Pharmaceutical sales (Top Sales Person)

• Research of Fisher Franchise Equivalent Products to market to scientists at Merck & Co.

• Required extensive interaction with client base in U.S.A.

Elkton, MD 484-***-**** cell ***********@*****.***

Annmarie J. Harris

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WIDENER UNIVERSITY, Chester, PA (Main Campus)

3/1994 TO 12/2002 - Senior Adjunct Laboratory Coordinator

• Facilitated the running of the chemistry laboratories

• Organized and oversaw the set up of laboratory experiments

• Monitored and prepared chemicals required for each project

• Monitored stockroom supplies

• Managed disposal of chemicals

• Principal flutist for Widener University Chamber Group

DUPONT-MERCK PHARMACEUTICAL CO. Wilmington, DE

5/1989 TO 12/1993 - Associate Scientist

• Stability Sample and Excipients Coordinator

• Physical Testing Laboratory

• Dissolution Laboratory (AR & D)

• Biophysical chemistry laboratory Pre-development (AR &D)

DUPONT ELECTRONICS

5/1988 TO 5/1989 - Research Assistant-Internship (R & D)

• Developed solder paste test method using the M.U.S.T. Solderability Tester

• Patent filed for solder paste test method

OBERLIN COLLEGE

• Research Assistant to Head of Chemistry Department (Published-Action of

Hemoglobin in mono-oxygenase reactions) under the charge of Dr. William H. Fuchsman

• Research for Calculus Department under charge of Dr. Michael Henley

PROFESSIONAL ORGANIZATIONS

• Past Member of Drug Information Association (DIA)

• Past Associate Member of The Delaware County Chamber of Commerce

• America’s Registry of Outstanding Professionals 2005-2006

EDUCATION

OBERLIN COLLEGE

• Bachelor of Arts (Biochemistry)

• Oberlin College Conservatory of Music-Studio with Ralph Rautenberg,

Co-principal flutist of the Cleveland Symphony Orchestra

• Student of Carol Brown – Principal flutist of the Delaware Symphony

Honors, Awards, Activities

• Ford-Mellon Student Research Scholar

• DANA Grant Recipient for Research

• Honored as an Oberlin College Outstanding Chemistry Student

• DuPont Summer Professional

Elkton, MD 484-***-**** cell ***********@*****.***

Annmarie J. Harris

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• Secretary of the Oberlin Honor Committee for 2 years and an active member for 4 years

• Flutist for the Oberlin Jazz Ensemble

• Second Chair Flute for Oberlin’s Symphonic Band

• Tutor for Algebra and other mathematical subjects

• Bible study conductor

CLAYMONT HIGH SCHOOL

• Graduated valedictorian with 4.0 Average

Honors, Awards, Activities

• AAUW Scholar

• Presidential Scholarship Award

• United States Senate Youth Scholar

• Rotary Club Scholar

• Delaware All-State Band Scholar

• Governor’s School for Excellence Scholar

• Brandywine Black Professionals Association Scholar

• Recipient of F.A.M.E. award for 2 successive years

(Forum to Advance Minorities in Engineering)

• Delaware All-State Band 1st chair Flute

*References available upon request

Elkton, MD 484-***-**** cell ***********@*****.***

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