CURRICULUM VITAE CURRICULUM VITAE * 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: kr12bf008@westpost.net II. EDUCATION SCHOOL DATE MAJOR/MINOR COURSES DEGREE KEAN UNIVERSITY, Union, NJ(GPA: 3.8) FELICIAN COLLEGE, Lodi, NJ(GPA: 3.5) MIDDLESEX COUNTY COLLEGE, Middlesex, NJ(GPA:3.8) 1998 1987 1977 Masters in Public Admin. Emphasis in Healthcare/ Health Management Bachelors of Science in Nursing Associate of Science in Nursing, Phi Theta Kappa MPA BSN ASN III. MERCK/MRL EMPLOYMENT HISTORY _TITLE: PRODUCT SCIENTIFIC SPECIALIST_

Nov 09 to Nov 10 * Provides high-quality review/verifies scientific accuracy and integrity of product-related promotional materials. Assists in the formulation of objectives/participates in the development and delivery of medical educational materials (includingresearch, writing/production of materials) for internal/external customers. * Customer-oriented approach/works effectively in cross-functional teams. Strong working knowledge of medical terminology/pathophysiology/laboratory diagnostic tests. Exercises a high order of product knowledge and human relations skills. Collaborative team player/knowledge of drug information processes. * Develops standard/unique Professional Information Request (PIRs) and responds daily to medical inquiries. Identify emerging medical trends, marketplace issues (e.g., Medical Inquiry Trends, Business Intelligence) and quality assurance issues and share with appropriate personnel. Receive, document, and report spontaneous reports of possible adverse drug reactions. AWARD OF EXCELLENCE 9/2010: _Marketing and Leadership Principles Recognized_ for collaborative effort in co-development of PSS new employee orientation guide, currently implemented. TITLE: _ASSOCIATE CLINICAL RESEARCH SPECIALIST_ Jan/Feb 08 to Nov 09 * Co-authored clinical protocols (Phase III), Clinical Development Plans, federal regulatory documents, narratives, abbreviated CSR, and other scientific documents. * Medically monitored patients enrolled into clinical studies in real time and reviewed aggregate data for safety and efficacy trends. Operated within a matrix environment to carry out the conduct of specific trials. Member of medical monitoring team (MTT). Successful in working independently and in collaboration with others: vendors/ICON/PPD/CTMS/IVRS/TMF. * * Knowledge of safety reporting and regulatory compliance. Receive, document, and report spontaneous reports of possible adverse drug reactions to Safety. Follows guidelines and procedural documents, works with SOPas. Provided training to subsidiaries/sites for pulmonary function testing to support respiratory clinical study. Strong knowledge of medical terminology, pathophysiology and laboratory diagnostics tests. Able to summarize medical information. Strong attention to detail and accuracy, able to manage own workload, prioritize, plan and organize assignment and work under strict timelines. Knowledge of drug information processes.

* Provided support (study start up, maintenance and close out) for respiratory clinical study and bone study (special LDRC projects). Support creation and formatting of Trial Newsletter for current bone study, highlighting significant information to facilitate study. * _AWARE OF EXCELLENCE_: _Marketing and Leadership Principles Recognized_ for collaborative effort for 2008 Pediatric sWMA approval for Cancidas. TITLE: _REGULATORY WRITER_ Jan 02 to Jan/Feb 08 * Key member involved in the process of reviewing, developing and coordinating approval of a US label, EU and ROW [Cancidas, Crixivan, Noroxin, Mefoxin, Cuprimine, Singulair], which reflects the Companyas medical and scientific knowledge on its products. Interact, facilitate and communicate clearly with multidisciplinary team members (regulatory, marketing, CMC, clinical, legal) to develop and write US/Headquartersa product labels while maintaining scientific rigor. Facilitates the resolution of issues by organizing and hosting Worldwide Product Circular Review Committee (LEAD) meetings, VP (LAST) meetings and initiate effective communication with 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 (NDAs, Centralized Procedure Variations, FPLs and SPLs) with updated labeling text meeting post-marketing clinical and safety requirements (CBEs and AERT). Completed major efficacy Pediatric filing with FDA physician labeling reformatting for Cancidas-2008. Utilizes strong technical writing skills; writes accurate and consistent draft labeling for ongoing developmental products as data is generated. Motivates team members/a self-starter with ability to develop collaborative relationships 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, safety update negotiations (QTc prolongation); EU renewal for Crixivan within very tight timelines and completed Cancidas PLR update and US pediatric sNDA filing, ROW and EU. TITLE_: CLINICAL OCCUPATIONAL REGISTERED NURSE _ July 98 to Jan 02 * Direct, initiate and implement patient care, utilizing the nursing

process for all populations. Coordinate overall interdisciplinary plan of patient care. Utilize occupational standards, concepts, practices and procedures to promote excellence through high quality healthcare, while containing cost. Provide counseling advice, regarding medical issues. Ensure a safe and healthy workplace; promote high standards, manage and review workmanas compensation, as well as, collect OSHA data and accurately document. * _RECEIVED LIFESAVER AWARD 10/1999__ _ IV. NON-MERCK EMPLOYMENT HISTORY ROBERT WOOD JOHNSON UNIVERSITY @ RAHWAY, RAHWAY, NJ July 1977 [Full Time-1977 to 1998] to PRESENT, currently Per Diem TITLE: EMERGENCY ROOM/ICU/CHARGE--STAFF RN * Responsible for multi-diagnostic conditions, emergency care/provides patient care utilizing the nursing process: patient assessment/planning/intervention/discharge. ACLS/PALS/CPR/IV/Critical Care certified. * Member of Research Committee for Emergency Department. Experience in case management and patient chart review for quality assurance, compliance, development of policy and procedure, as well clinical trials: data collection and review of documentation for a nationwide study in thrombolytic therapy, TPA and hormone study. * _RECEIVED CLINICAL EXCELLENCE AWARD 1993_ TITLE: ASSISTANT NURSE MANAGER JAN 1990 TO MAY 1997 * 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. Instrumental 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 safety and compliance. Involved in JCAHO preparation, review, inspection and improvement process. Developed, designed and implemented customer satisfaction programsa"call back system, currently in use. Key member in the development and maintenance of the aflexa and staffing programs.

JFK MEDICAL CENTER, EDISON, NJ TITLE: STAFF REGISTERED NURSE/ER DECEMBER 2010 TO PRESENT (FULL TIME) a Provides emergency health care for all populations across all age spans while utilizes the Nursing process for multi-diagnostic conditions (acute). ACLS, PALS, IV CERTIFIED BLS AND CURRENTLY TESTING FOR CEN CERTIFICATION. V. ACADEMIC EXPERIENCE MIDDLESEX COUNTY COLLEGE, EDISON, NJ UNION COUNTY COLLEGE, UNION, NJ Faculty adjuncta"1984-1986 Faculty adjuncta"1991-1992 Emergency Medical Technician Instructor VI. TRAINING SOURCE DATE CERTIFICATION Registered Professional Nurse (BSN, MPA) CPR/PALS/ACLS/IV/Critical Care certified Computer training, statistical analysis, Critical Care Course/IV certified 1978-Present 1978 to Present Licensure Certificate VII. SOCIETY MEMBERSHIPS Member, Drug Information Association (DIA) 2002 to 2010 _VOLUNTEER ACTIVE PARTICIPANT a"aHEALING THE CHILDRENa, A NON-PROFIT, NON-PARTISAN VOLUNTEER, CHARITABLE ORGANIZATION WHOSE PRINCIPAL PURPOSE IS TO SECURE/MAKE AVAILABLE FREE MEDICAL TREATMENT FOR NEEDY CHILDREN FROM THE UNITED STATES AND ABROAD.1995-PRESENT: TRAVELED TO EL SALVADOR, PANAMA AND HONDURAS._ Merck Institute of Science Education EU renewal for Crixivan within very tight 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 a" Rahway First Aid Squad a" 1995

Clinical Excellence Nomination Award a" Rahway Hospital, 1993 American Society of Safety Engineers- Certificate of Recognition as Healthcare Chairperson IX. PUBLICATIONS AND PATENTS Pending: publication of abbreviated CSR