Manager Management

LCDR Arianne Elayne Camphire, PharmD

Senior Regulatory Affairs Manager

***** **** ******** *** ? Buckingham, VA 23921

Phone 434-***-**** ? E-Mail . *********@*****.***

Curriculum Vitae Summary ? October 2010

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Decorated Commissioned Corps Officer transitioning from the United States Public

Health Service (USPHS) to the pharmaceutical/biotech industry. PharmD extremely

motivated to utilize & advance over seven years of distinguished military and

government administration (Food and Drug Administration, FDA) service.

Qualifications include diversified experience in clinical drug information,

pharmacovigilance, regulatory affairs, & compliance. Rated as an invaluable

member to the team, demonstrating high performance, high potential, leadership,

& advanced communication abilities.

Competencies & Skills include;

-Expert Project Management

- Supervisory Management

- Presentation/Public Speaking

- Experienced Liaison for KOL's

Key Opinion Leaders

- Team Building & Teaching

- Pharmacy Informatics

- Leadership Skills

- Advanced Communications

-Complex Problem Solving

- Conflict Resolution

- Medical & technical writing

-Strong Negotiation Skills

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EDUCATION, TRAINING and PROFESSIONAL DEVELOPMENT

. Doctor of Pharmacy, University of Pittsburgh School of Pharmacy

. Regulatory & Project Management Certification

. Facilitation and Negotiation Skills Training

. Food & Drug Law Institute (FDLI); Drug Law & Regulation Courses I-II

. Certified National Smoking Cessation Specialist, 2002-Present

. Certified in Basic Life Support (BLS) for the Health Care Provider,

2003-Present

. Specialties in Diabetes Education and Anticoagulation Management &

Psychiatric Pharmacy

. Professional Association of Diving Instructors (PADI); Open Water

certification, 2004

. Advanced computer/software knowledge in: Microsoft Office, Excel,

PowerPoint, FrontPage, Access, Outlook, Windows, Adobe, Oracle, COMIS,

OASIS

. Special Preparedness Disaster Training thru Office of Emergency

Response, Dept of Homeland Security

. Completed Basic and Independent Officer Training Course (2002)

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CAREER PROGRESSION:

. Executive Consultant for Coleman Research Group, Inc.

August 2009 - Present

Virtual Position

. The United States Public Health Service Commissioned Corps (USPHS)

June 2002 - June 2009

Duty Station: U.S. Food & Drug Administration

. Senior Regulatory Operations Officer, Lieutenant Commander (LCDR)

March 2006 - June 2009

FDA, Office of Compliance (OC), Division of New Drugs and Labeling

Compliance (DNDLC), Internet and Health Fraud Team. Silver Spring,

MD.

. Senior Regulatory Management Officer, Lieutenant Commander (LCDR)*

June 2002 - March 2006

FDA, CDER, Office of Pharmaceutical Science (OPS), Office of Generic

Drugs (OGD), Division of

Labeling and Program Support, Regulatory Support Branch (DLPS).

Rockville, MD.

* Ambulatory Care Pharmacist **

January 2007 - April 2009

National Naval Medical Center (NNMC)

Diabetes Care Center

Bethesda, MD

. Retail Pharmacist October

2003 - November 2006

Part-time Floater position

CVS Pharmacy, District of Columbia

. Managed Care Scholarship Recipient

June 2001 - August 2001

Merck-Medco, L.L. C.

North Versailles, Pennsylvania

. Psychiatric Pharmacy Intern

June 2000 - June 2001

VA Pittsburgh Healthcare System

Aspinwall, Pennsylvania

. Retail/Compounding Pharmacy Staff October

1998 - May 2000

Community Drug Compounding Pharmacy

Greenfield, Pennsylvania

* Promoted from Lieutenant (LT), Regulatory Management Officer (2005)

** Non-paid Volunteer; Professional Development Program - 112 Clinical

Hours required annually per Office of Force Readiness and Deployment

for Active Duty Status

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LCDR Arianne Elayne Camphire, PharmD

Senior Regulatory Affairs Manager

16836 West James Hwy ? Buckingham, VA 23921

Phone 434-***-**** ? E-Mail . *********@*****.***

Curriculum Vitae Summary ? October 2010

Arianne Elayne Camphire, PharmD

Senior Regulatory Affairs Manager

16836 West James Hwy . Buckingham, VA 23921

Phone . 434-***-****

E-Mail . *********@*****.***

Education:

Degree = Doctorate of Pharmacy, PharmD May

2002

University of Pittsburgh-School of Pharmacy. Pittsburgh, Pennsylvania.

Graduated on Dean's List

Cumulative GPA = 3.2

Pre-Professional Curriculum May

1998

University of Pittsburgh-College of Arts and Sciences. Pittsburgh,

Pennsylvania.

University Honors College Program

Professional Experience:

Coleman Research Group, Inc. August

2009 - Present

Buckingham, VA - Virtual Position

Executive Consultant (Elite Forum Member)

Helped investors (across all industries globally) collect and analyze

primary data to make more informed investment decisions in a shorter period

of time (i.e. more profitable time span).

Key Results:

0. Delivered highly targeted client-specific research through the Executive

Forum. Provided up-to-the-minute commentary on the "Healthcare" industry

and product trends related to area of expertise.

0. Educated institutional investors by closing the critical gap between

their existing knowledge base, and offered insight towards the possible

trends and ideas that are shaping today's markets.

0. Clients include 10 of the top 20 largest investment advisors, mutual

funds, hedge funds, and private equity firms.

Food & Drug Administration March

2006 - June 2009

Office of Compliance (OC), Division of New Drugs and Labeling

Compliance (DNDLC), Internet and Health Fraud Team. Silver Spring,

Maryland.

Senior Regulatory Operations Officer

Enforced the misbranding and new drugs provisions of the Federal Food,

Drug, and Cosmetic Act to ensure marketed drug products are safe and

effective for their intended uses and are properly and legally labeled.

Key Results:

0. Conducted undercover surveillance to detect & remove products which

posed a health hazard (directly or indirectly) to the public via

deceptive & misleading advertisements.

0. Issued press releases & other campaigns such as the iPledge Risk

Management Program for Accutance to increase consumer awareness of

illicit activity & potential risks.

0. Prevented diversion of counterfeit, sub potent, adulterated, and

misbranded prescription drug products. Prescription Drug Marketing Act

(PDMA).

0. Addressed public health risks associated with legal violations.

Implemented format to identify, assess, and prioritize significance.

Confirmed products were not unapproved INDs/NDAs, monitored MedWatch

reports, USP Pharmacopia, & consumer complaints, and/or submitted Health

Hazard Evaluations (HHEs) to the appropriate New Drug divisions.

0. Kept current in product and medical knowledge, implemented best

pharmacovigilance practices including Risk Evaluation Mitigation

Strategies (REMS).

0. Advised and provided comments to the Center Director and other Agency

officials on existing/emerging regulations and guidelines involving

dietary supplements, drugs, cosmetics, biologics, and devices.

0. Coordinated Field Office relations; offered support and guidance on case

development and regulatory actions. Managed assignments, deadlines, &

follow-up submissions in the Field Tracking System

0. Project Team Leader for division's International Strategic Initiative.

Established relationships with international enforcement agencies to

increase compliance and decrease accessibility of fraudulent products

from foreign sources. Created Microsoft Access database to track and

report project's success.

0. Member of the international Mexico, United States, Canada Health Fraud

Working Group (MUCH). Participation included focused enforcement and

compliance actions; Advisory Letters, Warning Letters and import refusals

against companies promoting bogus products.

0. Placed in Charge of Internet & Health Fraud Team, supervised staff of 5.

Additional responsibilities included leading team level and division

level meetings, document approval/sign-off, etc.

0. Participated and monitored trade shows, expo's, and conventions

featuring dietary supplements, nutraceuticals, cosmetics, and homeopathic

products.

Food and Drug Administration June

2002 - March 2006

Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD),

Division of Labeling and Program Support, Regulatory Support Branch

(DLPS). Rockville, MD.

Senior Regulatory Management Officer - Promoted from Lieutenant (LT)

Regulatory Management Officer.

Managed the review of Abbreviated New Drug Applications (ANDAs), 505 (b)

(2)'s, suitability petitions, & all other document submissions from initial

receipt to completion.

Key Results:

0. Determined completeness & acceptability of applications for filing;

verified that submissions complied with all regulatory, scientific, &

technical requirements.

* Gained extensive knowledge of patent certifications (PI-PIV), Method

of Use (MOU) statements, 30 month stays, 180 days exclusivity,

grandfathered drugs, & patent litigation.

* Focused on bioequivalence data (dissolution, pharmacokinetic, clinical

endpoints, confidence intervals, area under the curve measurements);

Chemistry Manufacturing & Controls (CMC) [components & composition,

batch formulations, specifications & tests, packaging, & stability];

microbiology data; & Structured Product Labeling in eCTD format. ***

Review process similar to NDAs, & BLAs

* Implemented International Conference on Harmonisation (ICH)

guidelines, enforced Good Review Practices (GRPs), Current Good

Manufacturing Practices (CGMPs), & Good Laboratory Practices (GLPs).

* Consecutively rated highest performer to review application &

submissions within statute time frame.

0. Appointed Alternate Drug Shortage Coordinator. Located substitute or

foreign sources of the drug product in demand by synchronizing efforts

with drug industry, Office of Compliance & Office of Review Management.

0. Expedited ANDAs for antiretroviral submission per the President's

Emergency Plan for AIDs Relief (PEPFAR).

0. Served as FDA liaison; Responded to a broad array of inquires generated

by the Branch Chief, Office of Chief Counsel, Congress, health

professionals, legal counsel, general public & other divisions within the

government.

* Corresponded with Industry. Identified submission discrepancies,

verified CMC, & quality assurance. Provided expert consultation on

guidance documents, & facilitated meetings as necessary.

0. Implemented training tools & strategies that streamlined the regulatory

review process for increased productivity & efficiency.

0. Acting Branch Chief upon request. Supervised staff of 11, rectified

branch correspondence, approved final reviews, & safeguarded applicant

confidentiality.

0. Delegated lead positions within Branch; Suitability Petitions

Coordinator & pIV list Manager. Facilitated & presented petitions to Key

Opinion Leaders seeking permission for a change from a Reference Listed

Drug. Similarly tracked & anonymously published patent challenges

against innovator products on OGD's website.

0. Contributions increased the availability of generic access to the

American public, causing billions of dollars in savings for consumers.

CVS Pharmacy October 2003

- November 2006

District of Columbia

Retail Pharmacist

Part-time Floater

Provided specialized pharmaceutical services to improve drug usage &

therapeutic outcomes including, but not limited to, advising physicians on

issues concerning drug therapy, the inherent toxicity of drugs & their side

effects, as well as assisting in the prescription of appropriate doses.

Key Results:

0. Processed prescriptions efficiently in high volume urban settings

throughout the District (avg 300 Rx's/day). Learned to work as

independent leader & problem solve complex scenarios. Ultimate focus

remained on quality customer service & continuous quality improvement.

0. Coordinated the activities of assigned pharmacy technicians; ensured

compliance with federal, state & local laws; issued control substances &

maintained lawful records with accuracy; demonstrated patience &

compassion for patients.

Merck-Medco Managed Care, L.L.C.

June 2001 - August 2001

North Versailles, Pennsylvania

Managed Care Scholarship Recipient

Performed pharmacy operations & pharmacist's responsibilities. Participated

in clinical programs & interventions with patients &/or prescribers (DUR,

physician calls, QA, formulary or therapeutic substitution); coordinated

daily clinical conference calls; researched/presented specific drug topics

for clinical teams, published "Communication with other Health Care

Professionals." Created and implemented use of consumer diabetic supply

handbook. Complete with patient friendly instructions and detailed

illustrations.

Veteran's Administration (VA) Pittsburgh Healthcare System

March 2001 - June 2001

Aspinwall, Pennsylvania

Psychiatric Pharmacy Intern

Prepared, dispensed & ensured safe, appropriate, cost effective drug

therapies for patients according to physician orders & VA established

guidelines. Focus was on Psychiatric Pharmacy and Behavioral Health.

Key Results:

0. Conducted medication histories, assessed compliance & recommended

adjustments to achieve patient goals; completed Patient Care Rounds with

physicians & gave proper counseling of prescribed meds.

Maintained liaison relationships with medical & nursing staff; served as go-

to-person for drug resource info, &/or current regulatory affairs

knowledge. Researched developments in new medication therapies &

proactively presented prospective new medications to the

institution/Pharmacy & Therapeutics Committee.

0. Primary rotations/experiences included; Mood Disorders, Schizophrenic

Disorders, Behavioral Medicine Clinic, Anxiety and Adjustment Disorders

Clinic, Post-Traumatic Stress Disorder Clinic, Addictive Disorders,

Neurobehavioral, Geriatric, etc.

Community Drug Compounding Pharmacy October

1998 - May 2000

Greenfield, Pennsylvania

Compounding Pharmacy Intern

Offered pharmacy compounding to improve the quality & safety of pharmacy

services provided to the general public. Vital skills & talents acquired at

independent location recognized for quality customized medications.

Specialties included Natural Hormone Replacement Therapy, Pain Management,

Procarin, Secretin & Veterinary Compounds.

Key Results:

Received highly skilled training & mentoring by Compounding Accredited

Pharmacists.

Recognized the advantages & importance of meeting individual's unique needs

& determined practice essential to the profession of pharmacy.

Stressed patient-professional counseling & customer care, as required when

dispensing or educating persons about novel &/or sensitive therapies.

Pharmacy Practice August 2001 -

April 2002

Pittsburgh, Pennsylvania

Internships

Rotations included Health and Pharmacy Management - University of

Pittsburgh Medical Centers, (UPMC); Ambulatory Patient Care,

Diabetes/Warfarin Clinic, presented The Effects of Herbal Interactions with

Warfarin - VA Oakland Hospital; Food and Drug Administration (FDA);

Psychiatric Pharmacy both Institutional & Outpatient Care - Forbes Pharmacy

& Western Psychiatric Hospital; Critical Care Specialties (NICU)/ (ICU) -

Magee Women's Hospital; & Oncology - UPMC Shadyside Hospital.

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Accomplishments/Awards/Recognition

* Awarded four Outstanding Commendation Medals for national recognition &

significance; three Unit Commendation Medals - presented for a level of

proficiency & dedication distinctly greater than that expected of the

average officer; two Crisis Response Service Awards - for critical

interventions at geographical locations separate from duty stations (i.e.

Hurricane Katrina); also honored with an Achievement Award - for career

noteworthy contribution(s) toward the attainment of Program objectives.

* Prestigiously hand-selected as an Executive Assistant (EA) to Rear

Admiral, Upper Half (2-star) Linda Tollefson, for the Incident Response

Coordination Team (IRCT). EA/IRCT obligations included continuous on-

call status, & special preparedness training in the event of a national

disaster.

* Elected into highly competitive PharmPAC (Pharmacist Professional

Advisory Committee) as an Historian; awarded 1st time Commissioned

Officer's Foundation grants for a Historical Timeline; a Pharmacy

Category 75th Anniversary military challenge coin, a coin holder

historical brochure card, a commemorative historical presentation, & a

published article in "Pharmacy Today".

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Professional Activities and Associations

* Junior Officer's Advisory Group & Junior Officer Student Extern Training

Program Mentor

* Associate Recruiter, Point of Contact Preceptor (POC) for the University

of Pittsburgh, School of Pharmacy

* FDA Office of Crisis Management Emergency Operation Center Volunteer

* Combined Federal Campaign Volunteer

* Member of American Diabetes Association, American Society of Health

System Pharmacists, American Pharmaceutical Association, American Public

Health Association, Regulatory Affairs Professionals Society, Medical

Science Liaison Careers Group, Reserve Officers Association (regular Mid-

year attendance as permitted)

* Kappa Psi Pharmaceutical Fraternity

* Received President's Challenge recognition for passing the Annual

Physical Fitness Test in Top 5%

Contact this candidate