Peter Stec Email & Phone Number

Plymouth Meeting, Pennsylvania, United States

• As part of the Promotional Review Team (PRT) (consists of GMIS, Physician, Lawyer and Regulatory personnel), reviewed and approved, from a medical perspective, all U.S. and Global branded and non-branded product promotional and training material for the Established Brand Franchise. Once approved, the appropriate U.S. promotional pieces would be submitted to the FDA for regulatory approval.• Review and Approve standard responses developed by the Global Scientific Content (GSC) to address unsolicited Medical Information Requests (MIR’s) regarding Organon products from Health Care Professionals (HCP’s) via the Informational Request Management System (IRMS), and eventually via Veeva Vault Med. Comms. Requests are received via sales representatives, Medical Affairs or through the Organon Service Center (OSC phone center). Responses are handled either through letters or phone calls to HCP’s. Developed non-standard responses by searching Pub Med and Embase for the most current data from published research articles.• As a “Start-up Company” - Part of the Transition team for Global Medical Information and Promotional Review

Pennsylvania, United States

• Responsible for the creation of global scientific material to be used by Field Medical and Medical Information personnel. • GSC develops Scientific Response documents in the form of Merck Information Letters (MIL’s), Slide Decks, FAQ’s, as well as disease state presentations and summaries of Clinical Practice Guidelines.

Pennsylvania, United States

• As part of the Promotional Review Team (PRT) (consists of GMIS, Physician, Lawyer and Regulatory personnel), reviewed and approved, from a medical perspective, all U.S. and Global branded and non-branded product promotional and training material for the Respiratory Franchise. Once approved, the appropriate promotional pieces would be submitted to the FDA for regulatory approval.• Created responses to unsolicited Professional Information Requests (PIR’s) regarding Merck products from Health Care Professionals (HCP’s) via the Informational Request Management System (IRMS). Requests are received via sales representatives, Medical Affairs or through the Merck National Service Center (MNSC). Responses are handled either through letters or phone calls to physicians and pharmacists. Developed standard documents and updated annually for the IRMS database by searching Pub Med and Embase for the most current data from published research articles. • Provided disease and product training to sales representatives and TeleRx personnel (for the Respiratory Franchise and Diversified Brands (DB) (hundreds of products representative of multiple Franchises) in order for them to converse with HCP’s in the field or via phone calls.• Lead the DB sub-team. Organized the DB Franchise for manageability. Divided the products among the team and created an assignment list to keep track of contacts for the various products. Re-evaluate the responsibility of the products annually. Address all general questions for the Franchise. • Provided UAT support for the GMI transformation for both Veeva Vault MedComms and IRMS Web• Using my nursing background, provided input to Clinical Research in protocol development. • Responsible for various projects within the department.

Pennsylvania, United States

• Received, triaged and processed adverse event reports in a timely manner via NWAES from local and international subsidiaries in accordance with worldwide regulatory requirements.• Read and review professional literature to determine and process adverse events within published articles, abstracts and manuscripts. • Processed and reviewed NDA and IND periodic submissions of adverse events for all marketed/study drugs and vaccines to be forwarded to the FDA. • Responsible for managing several business agreements among Merck and outside companies to ensure compliance with adverse event reporting. Troubleshoot and resolve any issues between the agreements through oral and written correspondence which is performed on a daily basis. • Trained and mentored several new employees within the department. • Responsible for all "End of Study" and "Individual Case" unblinding of all studies, both domestic and international, for all serious adverse events. •Assisted the NWAES Database Development Team with UAT Testing of Releases 1A, 1B and 1C, in all NWAES worldwide. Assisted in the development and execution of Test Cases in Quality Center. Performed "smoke", regression, and formal execution testing of cases in NWAES to ensure that the new additions and changes to the database were performing properly.

Pennsylvania, United States

• Provided total nursing care for patients with cancer-related issues. Monitor Neoplastic medications and therapies for various types of cancers and pain management.

Pennsylvania, United States

• Oversaw all daily clinical trial activity for several domestic and international sites. Interact directly with Study Coordinators to resolve any protocol issues. • Managed the entire vaccine distribution program for protocol 019 within a Human Papillomavirus study. Tracking of all vials, administered vaccinations, quality issues, and any temperature excursions related to the storage of the vaccine. • Performed medical review of all incoming data by tracking and resolving all discrepancies via an in-house database Clinical Tracking System (CTS). Data is reviewed on a continuous basis. • Assisted pathology panel with biopsy slide tracking and handling for adjudication.• Tracked and resolved all specimen shipping discrepancies for protocol 019. • Attended in-house and outside training related to the development and maintenance of clinical trials within Merck.

Pennsylvania, United States

• Received, processed in the WATSIN database, and responded to all non-medical product complaints, adverse events, and inquiries received by the Product Quality (PQ) Department.• Received and processed Adverse Event (AE) reports via phone from health care professionals and consumers and from GSSE. Initiated laboratory evaluations for medications related to the reported AEs. • Acted as liaison among GSSE, Global Medical Communications (GMC), Customer Service (CCSU), Professional Services, Laboratory Personnel and other departments within Wyeth to provide direct customer service to health care professionals and consumers. • Reviewed and translated laboratory evaluations to health care professionals and consumers via verbal and written correspondence. • Identified quality issues with products within our company and reported this information to the appropriate personnel within the company; assisted in the implementation of changes to resolve various issues. • Responsible for several business agreements between Wyeth and outside companies. Assuring that all reports related to products were processed, reviewed and forwarded to business partners as appropriate. Liaison between Wyeth and business partner to address any issues or questions.• Managed all processes related to collecting adverse event (AE) information from external and internal customers and consumers. Implements processes with the guidance of company and departmental Standard Operating Procedures. • Reviewed all AE information collected by the team and forwards the information to Global Safety Surveillance and Epidemiology (GSSE) and the laboratory for evaluation as appropriate. • Followed each individual AE file through the entire process until the laboratory evaluation is completed and reviewed, receives signature, and is forwarded to the appropriate personnel. •Participated in the implementation and completion of several ongoing projects within the Product Quality Department.

Philadelphia County, Pennsylvania, United States

• Monitored all waived and complex bedside testing at the hospital. Enforced POCT policies and procedures as developed by the regulatory commissions of the College of American Pathologists (CAP) and Joint Commission of Accredited Health Organizations (JCAHO). • Developed and implemented a Quality Assurance Program for Coagulation, Blood Gases, and Glucose testing, under the licensure of CAP and JCAHO.• Implemented an Internal/External Proficiency Testing Program and a Diagnostic Instrumentation Validation Program according to CAP and JCAHO guidelines.• Conducted comprehensive training sessions for Nursing staff, including instrumentation method and use, testing procedures, and reporting. • Performed routine analysis and inspection of Quality Control documentation to ensure compliance. • Acted as liaison between the Laboratory and Nursing Staff. Compiled, analyzed, and distributed monthly reports and data to Nurse Managers, Directors and Hospital Administration. • Assisted in the implementation of a Predistribution Quality Control Program for Blood Gas Instruments. • Developed technical skills as in-house POCT Instrumentation Specialist—maintained, troubleshot and repaired over 160 diagnostic instruments. Tested and evaluated all new bedside instrumentation being considered for purchase.

Pennsylvania, United States

• Collaborated with the health care team to provide total Nursing care during length of stay to inpatients arriving from Direct Admissions, ER, OR, units, and outside hospitals. • Proficient in utilization of various hospital equipment (EKG, pumps, etc.). Skilled in the use and side effects of various medications. • Utilized teaching materials to provide patient education and reinforcement on issues such as diets, medications, rehabilitation, cardiac catheterization, angioplasty, electrophysiology studies, and various other medical procedures and conditions. • Intensive training on telemetry unit function and utilization. Proficient in the recognition and interpretation of cardiac dysrhythmias.

Pennsylvania, United States

• Coordinated all administrative activities in the office and research laboratory of Professor Mark I. Greene M.D., Ph.D., F.R.C.P. • Managed the preparation and submission of research grants to various grant agencies, foundations, and businesses for research in oncogenes, receptor base drug design, and proteomic research.• Processed and submitted manuscripts for publication to the journal of DNA and Cell Biology. Drafted and maintained correspondence between authors and editors. Monitored progress of manuscripts forwarded to publishers. Coordinated seminars for invited speakers of the Departments of Pathology and Immunology. • Supervised and trained employees to assist with maintenance of daily activities within the laboratory.

Pennsylvania, United States

• Provided assistance to two editors of three business periodicals by performing research, supporting databases on corporate restructuring, and maintaining records on advertising clients.

Bsn, Registered Nursing/Registered Nurse

B.S., Municipal Managment