Training Project

Shelly Keesee

574-***-****: *************************@*****.***

Chemical Engineer, with 18+ years of experience in documentation design and implementation specializing in

regulatory medical writing in the pharmaceutical, biotechnology, and medical device industries for submission to

regulatory agencies, institutional review boards (IRBs), and medical institutions in Europe, Japan, USA and Canada.

Document therapeutic areas: diabetes, cardiovascular, infectious disease, oncology, CNS, GI, dermatology, respiratory,

hematology, endocrinology, genitourinary, acute/ chronic pain and anti-inflammatory.

Summary of regulatory documents authored:

• Protocols :concept/review(40), protocols(90), amendments(15), addendum(5),

• Clinical Study Reports: Preclinical (10), Phase I (12), Phase II (30), Phase III (25), and phase IV or late phase

studies (25).

• ICF : master, country-specific (7), CSR (phase I=6, phase II=3, phase III=5, phase 4/late phase = 4),

• Patient narratives (studies(5); 500-600 patients),

• Submission/Response (INDA(4), NDA ( 2), AP ( 1)),

• Statistical Analysis Plans (15),

• Clinical Trial Registry summaries (40),

• PSURs (2),

• Risk profiles (22).

Pharmaceutical Related Skills Validation Related Skills

Project Management ISO 14001/13485/9000

Alliance Management Process Mapping

Regulatory Submission Documentation CAPA Investigations

Customized templates (including CTD and PASS) Database development

Specification Development Legacy System Validation

Quality Systems BMS Validation / HVAC

Documentation System Development and Management Traceability Matrices

Regulatory Compliance Design History Files (DHF)

Training of Medical Writers SDLC Development

Computer Based Training Development Root Cause Analysis

FDA, ICH, EMA, ISPE, HPB GMP, GLP CFR11, 30 CFR, API, TPD and GCP fluent Computer System Validation (CSV)

Bid Proposals ISO Certification/ Recertification

Pharmacokinetics Facilities / Utilities Qualification

Statistical Analysis Equipment Qualification (IQ/OQ/PQ)

• Process Validation (OQ, PQ, PPQ)

Audits

FREELANCE PROJECT EXPERIENCE

Medical Regulatory, Technical and Scientific Communications Writing, multiple locations: 1994-current

Plan, write, evaluate, update, and edit regulatory documents (protocols, informed consent, full and abbreviated clinical study

reports [CSR], interim CSRs, patient narratives, integrated safety and efficacy reports [ISS/ISE], eCTD/CTD Modules 2 and 4-5,

clinical trial registry summaries, clinical evaluation reports, clinical summary reports for clinical drug review (CDR) documents,

various regulatory documents, and other IND/NDA-required regulatory documents) for submission to regulatory agencies,

institutional review boards (IRBs), and medical institutions in Europe, Japan, USA and Canada. Develop study design expertise

in real-life evidence-based studies (e.g. retrospective/prospective, interventional/non-interventional), preclinical and phase 1-4

trials.

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Clients

United Health Group 2012- 2013

Authoring and QC of pharmaceutical regulatory documentation for various UHG clients. Computer Based Training

development and creation.

Amgen 2012- 2012

Authoring technical transfer documentation for NDA.

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Amgen 2011-2012

Review documents for Global Quality and Compliance to ensure formatting consistency and adherence to style

manuals. Provide guidance for improvement in effectiveness and readability of documents. Author of technical

manuals with the aid of SMEs.

Professional Medical Writers, LLC 2008 to Current

Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR

summaries for multiple products clients at all phases of development.) Responsible for project management.

Eli Lilly, Indianapolis, IN 2007 to 2008

Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR

summaries for multiple product platform teams at all phases of development.) Responsible for project management and

training of new employees.

Bristol Myers Squib, Evansville, IN 2007

Responsible for development of an online interactive instruction and training manual for the IT infrastructure and

Architecture department.

InVentiv Clinical Solutions, Indianapolis, IN 2005 to 2007

Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR

summaries for multiple product platform teams at all phases of development.) Responsible for project management and

training of new employees.

Eli Lilly, Lafayette, IN 2003

Technical Writer for computer systems validation of lab and automation systems for large multi-national pharmaceutical

company. Project timeline management, co-ordination of multiple departments with respect to information gathering

and technical content.

Eli Lilly, Indianapolis, IN 2003 to 2004

Medical writer responsible for development of protocols, statistical analysis plans, addenda and amendments for same,

synopsis, risk profiles and other relevant documentation for Phase 3 clinical trials. Alliance project experience and

advanced alliance management training completed.

Vipertechnical Services, Toronto, ON 2001-2002

Owner of a recruiting agency for placement of degreed, experienced scientific personnel and high level executives for

pharmaceutical and biotechnology companies.

Novartis Pharmaceutical, Whitby, ON 2000

Technical writer preparing test methods, protocols, specifications, validation and stability reports for new and existing

products. Database management and document tracking. Archiving and file retrieval. Technology transfer and

harmonization of documentation between international facilities.

Supervisor Bioanalytical Documentation (Regulatory) 1999 to 2000

MAXXAM Analytics Inc., Mississauga, ON

(Full-time)

Prioritize all administrative duties. Overall management of and delegation of priorities and projects to departmental staff.

Responsible performance reviews. Collect and summarize information for departmental tax credit reports. Laboratory

audits monthly. Technical writing guidance and training. Literature searches and delegation of the same. Tracking of all

scheduled deadlines and status of all reports and projects. Act as Senior technical writer for pre-clinical and clinical

protocols, validation and study reports for clients in Europe, Japan, USA and Canada. Ensure all reports and

accompanying raw data are correct, GLP compliant and acceptable according to SOPs and protocols prior to submission

to SD for review. Interpret and accept data prior to reporting. Optimization of report templates for validation and studies.

Integrated & assessed client reporting requirements.

SmithKline Beecham, Oakville, ON 1998 to 1999

Responsible for development of training manual for QO department

Work on special projects with QO Projects Coordinator. Correspondence with QA Managers of outside contracts with

regards to Master site and batch documents. Maintenance of Master product files for submission. Verification of

validation documents and audits and control of such documents. Product launches. Writing SOPs to ensure procedural

compliance with guidelines and regulations.

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Astra Pharma, Mississauga, ON 1996 to 1997

Responsible for revision of existing specifications and test methods in accordance with FDA, TPP and USP guidelines.

Development of new specifications and test methods required for the Quality Control lab. Preparation of documentation

and official Certificates of Analysis for export submission qualification. Product and raw material handling and

coordination of export for same. Labeling and packaging insert QC and change control.

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FREELANCE (Non- Pharma) PROJECT EXPERIENCE

Validation/Technical Writer, multiple locations: 2001-current

Provide consulting services to medical device manufacturers and other industries, covering equipment qualifications,

ISO certification/recertification, CAPA remediation, legacy qualifications, and process/equipment and laboratory

validation. Authored validation protocols for Equipment Installation Qualifications, Operational Qualifications, Factory

Acceptance Tests, Control System Validations, Performance Qualifications and Validation Master Plans for new projects

or to ensure process improvements were in control. Act as Senior Technical Writer with oversight of all validation

documentation for all processes, equipment and methodologies developed at site by internal staff and consultants.

Development of new SOPs and methods.

Clients

RJ Reynolds Memphis, TN 2011

Process mapping of new production facility. Writing of SOPs, work instructions and forms. Guidance to client to ensure

compliance with FDA and industry standards.

Berkley Imperial, Houston, TX 2011

Editing and technical writing of submissions to BOEMRE for high pressure high temperature well designs.

Medtronic, Warsaw, IN 2009-2010

Development and revision of SOPs for Validation department. Review of all validation protocols prior to and after

execution. Engineering co-coordinator duties when required. Assisted with CAPA’s and internal audits of Validation

Master Plan. Validation of CNC equipment. Development of power point training slides. Building of SharePoint for

procurement dept. Acted as technical writing expert.

Simcoe Parts Service Inc., Alliston, ON 2001 to 2002

Team leader and technical writer. Developed an ISO 14001 system in its entirety and trained 300+ employees including

upper management for automotive parts facility. Internal auditing set-up. QS 9000 documentation management. GAP

Analysis. Performance metrics. Training program and database development and conducting training seminars for all

levels. Health and safety related to HAZMAT procedures. In charge of coordinating cleanup of large scale diesel fuel

spills occurring on site. Reporting of spills and emissions to Ministry of the Environment. Facilities auditing. Ordering of

supplies for Environmental Emergency Planning. Co-ordination liaison with Honda of Canada Manufacturing with

respect to programs and timelines of project.

Canatech Environmental, Barrie, ON 2001 to 2002

Tradeshows and sales calls for micronutrients, Bio Amendments and Bio Augmentation systems. Correspondence with

Agriculture Canada regarding new products legislation. Day to day management of office duties, AR/AP, administration.

Chemical testing and product development. Handled development of product brochures, exhibits and media relations.

EDUCATION

Dec 2013- State of Indiana Certified Nursing Assistant, Hagen Health Education, Warsaw, IN

1991-1994 Loyalist College of Applied Arts and Technology, Belleville, ON

Graduated with a diploma in Chemical Engineering

1988 Loyalist College of Applied Arts and Technology, Belleville, ON -Print Journalism

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