| Candidate Information | | Title | Executive Assistant Administrative | | Target Location | US-PA-Schuylkill Haven |
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Click here or scroll down to respond to this candidatePROFESSIONAL EXPERIENCEHarvestaff, contracted to Bayer Radiology, Labeling Specialist Street Address - presentSupported TechPubs Group fully remote positionV&V of produced labels, box artwork and IFUTake part in LDR meetingsSend documents to team for review/approvalUse of Enlabel, Windchill and Microsoft Office softwarePerformed all training programs as requestedHandled special projects as requestedHydro Aluminum Extrusions, Cressona, PA, Administrative Assistant 2020-2021Support Extrusion DepartmentOrdered office supplies, PPE supplies, furniture, and other items as requestedPrepared requisitions for approval by senior staffPrepared daily reports for department headTracked new personnel reviews, overtime sign ups, etc.Prepared Administrative Assistant Handbook for DepartmentInterfaced with Supervisors & leads to meet the needs of all team members on 4 shiftsAble to effectively prioritize tasks and assignments to meet long and short-term deadlinesStrong work ethic and willingness to take ownership for wide-ranging responsibilitiesCompleted projects (working independently) as assignedAssisted with Companywide InventoryAssisted other Admins and Departments upon requestNiagara Bottling, Hamburg PA, Shipping Associate 2019 2020Hydro Aluminum Extrusions, Cressona PA, Data Entry & Admin Assistant 2020 - PresentPrepared and printed load paperwork; interfaced with truck drivers (using my experience growing up in a trucking family) and warehouse personnel to meet shipping deadlinesVerified trailers in specific dock doors for loadingAssisted with inventoryCompleted projects as assignedProvided directions in person or over the phone to drivers looking for warehouse, lodging, food, fuel, scale, etc.Assisted with clean up following palletizer failure, dropped loaded pallets, etc.Attended all scheduled pre shift meetingsConfirmed trailers in yard, trailer #s and locationsInterfaced with shuttle vendor and drivers to maintain the flow of inventoryHerbalRue, Hamburg, PA 2019 - PresentFreelance/ConsultingAssisting client (small herbal companies) to become FDA CompliantRemote/Home Based position requiring collaboration, prioritization, communication skills, organization and the ability to work independentlyCFR Title 21 (multiple parts dietary supplements, food products, cosmetics, drugs, etc.)Quality Assurance (freelance for herbal company)Crafting/updating of 80+ SOPs (administrative, personnel, equipment use, GMP, quality assurance, record keeping, business-specific, etc.)Drafted Quality Assurance Plan, Quality Control Plan and Code of EthicsHandled vendor qualification, vendor management and NDAsActed as liaison between company and Department of Alcohol, Tobacco & Firearms as well as the State of Oregon Liquor Control Commission and US National Park Service.Set up testing program of post-manufactured tinctures as required under CFR Title 21 Part 111Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA (remote)Manager, Clinical Operations 10/2013 1/2018Assisted with CTIX-BRI-204 Phase II ABSSSI Clinical Trial; 4 sites; 215 subjects; positive resultsManaged the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Clinical Trial from Concept/ Protocol to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT patients); ~30.5% withdrawal rate; primary & secondary endpoints met (CSR still pending)Study Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.Remote/Home Based position required ability to prioritize tasks, work independently, and heavy focus on communication, organization and collaborationTherapeutic Experience: Anti-Infectives, Oral MucositisAssisted with creation & presentations of materials for Site Initiation VisitsAssisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trialsManagement of all vendors including those for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicingResponsible for overall IRB submissions for oral mucositis study with central IRBMade site visits as part of the team conducting SIVs, also made follow up visits to sites both trials)Supervised in-house unblended pharmacy monitor including review/approval of expensesOver-saw roll out of ClinTrialApp (unique opportunity for collaboration with app creators) for Oral Mucositis study; responsible for updating documents & other information in appActed at TMF Process Owner assisting w/resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file roomOrganized, procured, stored and tracked expenditures of clinical supplies for Oral Mucositis trialOversaw consultant responsible for shipping clinical suppliesWorked with vendor responsible for packaging, storing & shipping drug product to keep sites supplied at all timesAssisted with preparation of electronic documents for FDA submissionsFocused on research and trial compliance with CFR/FDA rules and regulationsAssist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissionsResponsible creating and maintaining for all submission documentsAssisted with compilation, preparation of & submission of IND for Oral MucositisCompleted GCP TrainingMember of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.PolyMedix, Inc. Radnor, PA 3/2010 4/2013Executive Assistant supporting Clinical Operations/Regulatory Affairs (Clinical Research) and Research TeamsPerformed key Executive Assistant as well as the following:Participated with compilation of Common Technical Document (IND for ABSSSI)Was assisting with compilation and preparation of IND for Oral MucositisAssisted with preparation and submission of Briefing Book for scheduled FDA MeetingsAssist with preparation of electronic documents for FDAAssist with compiling paper submissions to FDA including preparing multiple copies & shipping to FDA; also burned & tested CDs for submissionsAssisted with preparations for Due Diligence by potential investorsResponsible for uploads and removal of electronic documents in data SmartRoom; also providing access to viewers; maintaining order within the roomAssisted with preparation of Investigator Brochure and Clinical ProtocolsAssisted with contract negotiation of vendors for clinical supplies for trialsOrganize Investigator Meetings (contracts to travel) and other meetings as needed (internal & external) including budget tracking, attendance, vendor management, purchase of meeting supplies & incentives, etc.Able to effectively prioritize tasks and assignments to meet long and short-term deadlinesStrong work ethic and willingness to take ownership for wide-ranging responsibilitiesCompleted projects (working independently) as assignedProvided support to both the President and CFO of PolyMedix in the absence of their respective assistantsInVentive/MedFocus 3/2009 3/2010Contract assignment at GSK Bio supporting Procurement (King of Prussia, PA)Performed key Executive Assistant as well as the following:Scheduled meetings and presentationsLiaised with vendors for proposalsPrepared contracts and confidentiality agreementsFollowed up with study teams about contract managementPerformed tasks as requested by Director of Procurement & study support staffContract assignment at Wyeth supporting Clinical Team (Collegeville, PA) 2009Performed tasks as requested by team members & supervisory staff including coordinated with staff & team members in Cambridge, MAEncorium Group, Inc. King of Prussia/Wayne, PA 6/2006 11/2008Sr. Project Management AssistantSupported Chief Operations Officer & VP of Clinical OperationsAlso supported Project Management Teams and Business Development GroupPerformed key Executive Assistant as well as the following:Assisted QA/QC with scanning of documents and reports for electronic filingFunctioned as Feasibility Coordinator to assist Business Development to gather data to prepare bids and for bid defense utilizing TrialWorks/MS Word and Outlook (Therapeutic Experience: Oncology, Vaccines, Influenza, DVT, etc.)Acted as meeting and special event planner (10 100+ persons) and all corresponding logistics in US and international (Finland);Multi-city/multi-country travel arrangements including air travel, hotels and ground transportationVicuron Pharmaceuticals King of Prussia, PA 11/2001 12/2005Executive Assistant to Executive Vice President of Scientific AffairsSupported Director of Supply Chain OperationsManaged the calendar for the EVP, Directors and other department members, including updating of contacts utilizing MS OutlookHandled all invoicing, purchase orders and needs as requested by Accounts PayableTracked department budget (MS Excel) and was liaison to Finance Department (managed accruals; assisted with budgets preparation)Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.Multi-city/multi-country (US, Canada, UK, Italy) travel arrangements including air travel, hotels and ground transportationPrepared expense reports including multi-currency as well as USDAnticipated assistance needed by identifying problems, needs, options, and solutions before being askedAble to effectively prioritize assignments to meet long and short-term deadlinesProcess expense reports & monitored department expensesStrong work ethics and willingness to take ownership for wide-ranging responsibilitiesCovance (Radnor, PA) as an Admin Asst in the HR/Recruiting Department 1999-2001IBAH (Plymouth Meeting, PA) as data entry clerk & Admin Asst in Data Management 1996-1999EDUCATION:Katherine Gibbs Secretarial School, Philadelphia PA 1981-1982Graduate, Secretarial & Word Processing Program |
