CURRICULUM VITAE

I. PERSONAL DATA
A. Name: Katia Russoniello, RN, BSN, MPA
B. Home Address: 216 County Line Road, Branchburg, NJ 08876
C. Home Telephone: (732) 991-3842 Email: kr1120ee0@westpost.net

II. EDUCATION
School Date Major/Minor Courses Degree
KEAN UNIVERSITY,
Union, NJ

FELICIAN COLLEGE,
Lodi, NJ

MIDDLESEX COUNTY COLLEGE, Middlesex, NJ

1998

1987

1977
Masters in Public Administration
Emphasis in Healthcare/ Health Management
(GPA 3.8)
Bachelors of Science in Nursing
(GPA 3.5)
Associate of Science in Nursing,
Phi Theta Kappa
(GPA 3.8)
MPA

BSN

ASN
III. MERCK/MRL EMPLOYMENT HISTORY
Title: Product Scientific Specialist
3Q09 to 4Q10
* Reviews/verifies scientific accuracy and integrity of product-related
promotional/informational material. Member of the Promotional
Review team.
* Assists in the formulation of objectives and participates in the development a
nd delivery of medical educational materials (including research, writing and pr
oduction of materials) for internal and external customers.
* Participate in the creation of, and ensure adherence to, departmental and corp
orate policies and quality standards. Presented to National Service Center and M
edical team members.
* Receive, document, and report spontaneous reports of possible adverse drug rea
ctions.
* Responds daily to Professional Information Requests (PIRs) from healthcare pro
fessionals either in writing or by phone. Proactively develop medical response d
ocuments, revise/update existing documents in database.
* Develops standard/unique Professional Information Request responses to unsolic
ited questions from healthcare professionals, including internal clients.
* Performs searches of the literature, and analyzes topics for internal clients.
(1) search, evaluate, and summarize the published medical and scientific litera
ture; (2) work independently yet ensure strategic alignment of information with
key internal stakeholders and experts, as necessary; (3) identify emerging medic
al trends, marketplace issues (e.g., Medical Inquiry Trends, Business Intelligen
ce) and quality assurance issues and share with appropriate personnel.
* Exercises a high order of medical/product knowledge and human relations skills
. Collaborative team player.
* Award of excellence 9/2010: Marketing and Leadership Principles Recognized for
collaborative effort in co-development of PSS new employee orientation guide.

Title: Associate Clinical Research Specialist

1Q 08 to 4Q09
* Co authored clinical protocols (Phase III), Clinical Development Plans, federa
l regulatory documents, narratives, abbreviated CSR, and other scientific docume
nts.
* Medically monitored patients enrolled into clinical studies in real time and r
eviewed aggregate data for safety and efficacy trends. Operated within a matrix
environment to carry out the conduct of specific trials. Member of medical monit
oring team (MTT). Collaborative experience with vendors, ICON, and PPD, as well
as CTMS, IVRS.
* Receive, document, and report spontaneous reports of possible adverse drug rea
ctions to Safety. Follows guidelines and procedural documents, works with SOP's.
Knowledge/experience with safety reporting and regulatory compliance. Provided
training to subsidiaries/sites for pulmonary function testing to support respira
tory clinical study.
* Provided support (study start up, maintenance and close out) for respiratory c
linical study and bone study (special LDRC projects).
* Aware of Excellence: Marketing and Leadership Principles Recognized for collab
orative effort for 2008 Pediatric sWMA approval for Cancidas.

Title: Regulatory Writer

1Q02 to 2Q08
* Key member involved in the process of reviewing, developing and coordinating a
pproval of a US label [Cancidas, Crixivan, Noroxin, Mefoxin, Cuprimine, Singulai
r], which reflects the Company's medical and scientific knowledge on its product
s.
* Interact, facilitate and communicate clearly with multidisciplinary team membe
rs (regulatory, marketing, cmc, clinical, legal) to develop and write US/Headqua
rters' product labels while maintaining scientific rigor. Facilitates the resolu
tion of issues by organizing and hosting Worldwide Product Circular Review Commi
ttee (LEAD) meetings, VP (LAST) meetings and initiate effective communication wi
th Regulatory Managers worldwide.
* Coordinates, prepares and submits draft US labeling for submission to the FDA
to comply with FDA regulations. Prepare and release of headquarters documents (N
DAs, Centralized Procedure Variations, FPLs and SPLs) with updated labeling text
meeting post-marketing clinical and safety requirements (CBEs and AERT). Comple
ted major efficacy Pediatric filing with FDA physician labeling reformatting for
Cancidas-2008. Utilizes strong technical writing skills; writes accurate and co
nsistent draft labeling for ongoing developmental products as data is generated.
* Motivates team members/a self-starter with ability to develop collaborative re
lationships with diverse clientele.
* Design, develop and implement Policy and Procedure guidelines for department.
* Award of Excellence (2002, 2003, 2004, 2005, 2006, 2007, 2008): Marketing and
Leadership Principles Recognized for collaborative effort in MedDRA update, safe
ty update negotiations (QTc prolongation); EU renewal for Crixivan within very t
ight timelines and completed Cancidas PLR update and US pediatric sNDA filing, R
OW and EU.

Title: Clinical Occupational Registered Nurse 2Q98 to 1Q02

* Direct, initiate and implement patient care, utilizing the nursing process. C
oordinate overall interdisciplinary plan of patient care.
* Utilize occupational standards, concepts, practices and procedures to promote
excellence through high quality healthcare, while containing cost. Provide coun
seling advice, regarding medical issues.
* Ensure a safe and healthy workplace; promote high standards, manage and review
workman's compensation, as well as, collect OSHA data and accurately document.
* Participant in disaster preparedness planning, designed and developed protocol
s, policy and procedures, provide emergency care for occupational and non-occupa
tional illness and injury, assess pre-placement medical evaluation, as well as,
health and safety prevention and promotion programs.
* Working knowledge of Microsoft Word and PowerPoint, as well as, a medical data
base system.
* Consultant in major occupational health care setting. Develop, audit, and ana
lyze educational programs.
* Received Lifesaver Award 10/1999

IV. NON-MERCK EMPLOYMENT HISTORY

Title
Emergency Room/ICU/Charge--Staff RN
Robert Wood Johnson University @ RAHWAY, Rahway, NJ
July 1977 [Full Time-1977 to 1998] to present, currently Per Diem

* Responsible for multi-diagnostic conditions, emergency care/provides patient c

are utilizing the nursing process: patient assessment, planning, intervention an
d discharge. ACLS/PALS/CPR/IV/Critical Care certified.
* Develop/execute teaching plans and Policy Procedure updates.
* Member of Research Committee for Emergency Department.
* Involved in the development and organization of community committees.
* Experience in case management and patient chart review for quality assurance,
compliance, development of policy and procedure, as well clinical trials: data c
ollection and review of documentation for a nationwide study in thrombolytic the
rapy, TPA and hormone study. Working knowledge of Workman's Compensation and OS
HA Regulations.
* Experienced in monitoring clinical trials, as well as, site management.
* Received clinical excellence nomination award 1993
* Worked in ICU/CCU/SICU: July 1977 to 1983

Robert Wood Johnson University @ RAHWAY, Rahway, NJ

Emergency Room
Title: Assistant Nurse Manager
1Q 1990 to 4Q1997
* Responsible for the organization, functional management, and leadership of the
department, while containing costs and meeting staff and customer satisfaction.
* Coordinate, supervise, educate, and direct appropriate unit personnel. Instru
mental in the development, design and application of quality assurance programs,
standards of care, as well as Standard Operating procedures.
* Develop, audit and analyze programs for improvement.
* Developed and maintained personnel competency compliance records. Investigate
incident/accident reports as well as, inspected and surveyed workplaces for saf
ety and compliance.
* Involved in JCAHO preparation, review, inspection and improvement process.
* Developed, designed and implemented customer satisfaction programs - call back
system, currently in use.
* Key member in the development and maintenance of the "flex" and staffing progr
ams.

JFK Medical Center, Edison, NJ

Emergency Room
Title: Staff Registered Nurse
November 2010 to present (Full Time)
Emergency Room:
* Responsible for multi-diagnostic conditions (acute), emergency care for all po
pulations. Provides patient care that utilizes the nursing process: assessment,
planning, intervention and discharge.
ACLS, PALS, IV certified BLS and currently testing for CEN certification.

V. ACADEMIC EXPERIENCE
American Heart Association, Cardio-Pulmonary Resuscitation Instructor, 1970-2002
RWJUH@Rahway
Middlesex County College, Edison, NJ
Faculty adjunct-1984-1986
Emergency Medical Technician Instructor
Union County College, Union, NJ
Faculty adjunct-1991-1992
Emergency Medical Technician Instructor, 1995-1998
VI. TRAINING
Source Date Certification
Registered Professional Nurse (BSN, MPA)
Trauma course
American Heart Association, Cardio-Pulmonary Resuscitation Instructor
Pediatric Advanced Cardiac Life Support
Advance Cardiac Life Support
Certified OSHA Trainer in Construction, O.T.I
Certified OSHA Trainer in General Industry, O.T.I
Computer training, statistical analysis, safety training
Leadership in Management, ASSE
OSHA Overview for Occupational Nurses, O.T.I
Critical Care Course/IV certified
Occupational Safety, Health, Industrial Hygiene, Auditing and Inspection Auditor
y
EOSHI - Respirator Protection Program 1978-Present

2005-Present
1970-2002

1994-Present

1994-1996
1994-1996

Ongoing

1998
1978-Present

1978-Present
1999

Licensure

Certificate
Certificate

Certificate

Certificate

Certificate
VII. SOCIETY MEMBERSHIPS
Member, Drug Information Association (DIA) 2002 to 2009
Occupational Health Nurses Association, 1998-2002
American Society of Safety Engineers member, 1994-Present (Healthcare Chairperso
n 1995-2002)
Appointed to New Jersey State Industrial Safety Commission, 1995-2009
(Healthcare Chairperson 1995-2003)
Volunteer Active participant -"Healing the Children", a non-profit, non-partisan
volunteer, charitable organization (501 C3 status) whose principal purpose is t
o secure and make available free medical treatment for needy children from the U
nited States and abroad. The goal of the organization is to influence these chi
ldren by the humanitarianism of others so that, once restored to health, they wi
ll be inspired to make a positive impact in their societies.
1995-Present- traveled to El Salvador 2003, Panama 2004 and Honduras 2005
Merck Institute of Science Education & Promotion volunteer-participant (MISE), 1
999-Present
Emergency Nurses Association Member (ENA) 1984-present
New Jersey Safety Council Member, 1990-2009
New Jersey First Aid Council Member, 1977-Present
Board Member of Rahway Child Day Care, 1993-1995
Inactive exempt (Volunteer Member South River Rescue Squad), 1977-Present
Board of Health Member in South River, 2001-2002
VIII. ACADEMIC AND PROFESSIONAL HONORS
* Award of Excellence (2002, 2003, 2004, 2005, 2006, 2007, 2008): Marketing and
Leadership Principles Recognized for collaborative effort in MedDRA update, safe
ty update negotiations (QTc prolongation);EU renewal for Crixivan within very ti
ght timelines with 5 requests for supplemental information (RSI) and Completed 1
/2008-Cancidas PLR and pediatric sNDA filing for US, ROW and EU.
Special Achievement Award, Merck & Co. & Inc. 1999
RN of the Year - Rahway First Aid Squad - 1995
Clinical Excellence Nomination Award - Rahway Hospital, 1993
American Society of Safety Engineers- Certificate of Recognition as Healthcare C
hairperson
IX. PUBLICATIONS AND PATENTS
Pending: abbreviated CSR