Regulatory Affairs - Pharmaceutical Auditor - Paralegal
Resume:
KAETHE CIÉRA SKYE
Email: ***********@*****.***
PROFILE
Results oriented savvy international business professional with experience and expertise in international registrations, regulatory affairs, compliance, quality assurance, international sales & operations, project management and facilitation, account stewardship, data integrity auditing and database management. Excellent organizational, interpersonal and communication skills with an entrepreneurial spirit. Able to reassess priorities and function independently or as an interactive team member. Effective in building solid business relationships with both internal and external customers.
SKILLS
Novell GroupWise, MS Excel, EDMS, PDM (Product Dossier Manager), GPR (Global Product Registrations),DocXamine, SAP R2, Adobe Acrobat PRO 7.0 PDF, MS Office 2007, Outlook, MS Windows XP, exposure to live data network monitoring (WANs), e-Room, Oracle based proprietary databases, Access databases, Global Electronic Library Docbase (GEL), Intranet Change Control Logs, Scanning software, Global Local Administrator, Westlaw, Pacer Docket Sheet (DE Justice), LexisNexis (File and Serve), ISI Tools, PfLICC, Rosetta Pyramid, PREDICT toolbar, GDMS Author/Owner, Data Verification, Proofreading, SharePoint.
PROFESSIONAL EXPERIENCE
Client: Confidential Foreign Pharmaceutical Company with U.S. Agent in New Brunswick, NJ under Court Ordered Consent Decree April 2012 – Aug 2012
Consultant – PAREXEL – Data Integrity Audit – Stability
Audit: Laboratory Notebooks, Test Procedures, Stability Summary Reports audit of stability testing data
Client: Merck Sharp & Dohme, West Point, PA July 2011 – April 2012 Biologics - Vaccines
Consultant – Astrix Technology – Short-term project
Project work: Prepare Chemistry, Manufacturing and Controls (CMC) electronic documentation for submission to global markets – emerging markets
Client: Pfizer Pharmaceuticals, Groton, CT June 2010 – June 2011
CMC – Large Molecule
Consultant – Tunnell Consulting, King of Prussia, PA – Remote project
Authoring of Module 3 CMC information for global registrations – remotely
Project ended in June of 2011 six months ahead of schedule
Delaware Department of Justice – Attorney General’s Office Dec 2009 – May 2010 Widener Law Internship – Paralegal
Department: Major Civil Litigation
Non-paid Internship to complement paralegal studies at Widener Law. One semester.
Client: Wyeth Pharmaceuticals, Collegeville, PA July 2008 – Jan 2009
CMC – Large Molecule pharmaceuticals, OTC, Consumer Health
Worldwide Regulatory Affairs
Consultant – APEX Systems, Blue Bell, PA - Project
Receive in CMC electronic workbooks and product dossiers from Latin America and North America; note discrepancies and send notice to the Affiliate Regulatory Coordinator of any deficiencies
KAETHE CIÉRA SKYE
Page Two
Complete a full CMC QC (Module 3) of the product dossier information
Project work ended when second shift was eliminated in 2009
Client: MedImmune, Inc., Gaithersburg, MD July 2005 – Nov 2007
Biotech - Vaccines
Consultant – Kforce, Gaithersburg, MD
Regulatory Affairs functions for Respiratory Diseases Group
Permanent Employee: Regulatory Compliance: Advertising and Promotions: (Oct 2005 to Nov 2007)
Prepare submissions to CDER and CBER for Synagis®, Ethyol®, and FluMist® advertising and promotional pieces including press releases, speaker training slide decks, sales training
Client: National Institute of Allergy and Infectious Diseases, Bethesda, MD Feb 2004 – Feb 2005
Federal Contractor - SAIC-Frederick, Inc.
One year contract
Sole administrator of on-line database, OHSP (Office of Human Subject Protection)
Examine and verify submissions to the Institutional Review Board ensuring documents adhere to DHHS, NIH, OHRP & FDA regulations
Client: ASTRAZENECA, Wilmington, DE Feb 2003 – Dec 2003
Pharmaceuticals
Consultant – H.L. Yoh Scientific on-site at Astrazeneca - Project
Create / revise, validate, deploy electronic Global Standard Documents and Global Guidance Documents ensuring templates are free of corruption and adhere to AstraZeneca house style and FDA submission ready guidelines
Evaluator level of responsibility for the Intranet Change Control System
Liaison to functional and business representatives globally
U.S. project responsibilities transferred to UK parent company
Client: AVENTIS PHARMA, Bridgewater, NJ April 2002 – Dec 2002
Pharmaceuticals
Consultant: Kelly Scientific, Cranberry, NJ – Global Regulatory Database Project
Analysis and input of regulatory and marketing data into the Global Regulatory Database for ethical pharmaceutical product portfolio in Latin America, Central America, and the Caribbean
Extensive communications with Drug Regulatory heads within these regions
New Global Regulatory Database, which was a merger of three large pharmaceutical companies, was handed over to global affiliates after contractors completed the project of inputting daily reports while the new system was being built.
KAETHE CIÉRA SKYE
Page Three
HARTZ MOUNTAIN CORPORATION, Secaucus, NJ May 2001 – April 2002
Hartz Mountain Consultant
Registration renewals of veterinary quality, over the counter pet care pesticide treatments, remedies and feed products
Research and compile all required documentation for license maintenance in overseas markets
Knowledge of country specific regulatory policies Focus: EU and Latin America, some Canada
Regulatory liaison to the VMD (Veterinary Medicines Board, UK) and the IMB (Irish Medicines Board, ROI)
Severanced after a Boston investment banker’s group purchased Hartz Mountain which was a privately held company.
ZENECA Business Units --- Agricultural Unit and Specialty Chemicals Unit Jan 1998 – May 2001
ZENECA AG PRODUCTS, Wilmington, DE
Randstad Contractor: Registrations & Regulatory Affairs Coordinator
Supported State Registrations & Regulatory Affairs Group during merger with Novartis Crop Science
Interfaced with key state agriculture department officials regarding pesticide regulatory issues
Contract ended once the work had been completed and the company moved to North Carolina. Was asked if I wanted to join the new company in North Carolina (Syngenta) but I declined. Zeneca AG Products was spun off from AstraZeneca and then was picked up by Novartis Crop Science whose headquarters is in Greensboro, NC.
ZENECA AG PRODUCTS, INC., Wilmington, DE
Quality Assurance Associate-Zeneca AG Products Division
Defined and managed confidential product specifications
Managed databases and data integrity associated with commercial complaints, specifications, and quality assurance monitors
Worked collaboratively with Research & Development, Manufacturing, and International sectors in development of new product specifications
Resolved quality problems with customers
ZENECA SPECIALTY CHEMICALS, Wilmington, DE
Customer Relations Specialist, Industrial Biocides-Zeneca Specialties Division
Primary point of contact for current & potential Fortune 500 customers for all Industrial Biocides
Utilized SAP R2 in order fulfillment, inventory monitoring, and account information modules
Accepted a higher position with Zeneca AG Products in Quality Assurance.
SOFTMART, INC., Downingtown, PA April 1995 – Oct 1997
International Logistics Specialist
Company liaison to international affiliates of U.S. Fortune 500 accounts
Consulted and provided expertise on software licensing compliance and import/export policies
Supervised International Sales Coordinators.
KAETHE CIÉRA SKYE
Page Four
SOFTMART, INC., continued ….
International Sales Coordinator
Counseled international affiliates of Fortune 500/1000 companies in the area of software licensing and export policies
Brought in 1st year sales revenue of $1M from software licenses for international affiliates
Inbound Account Representative - Western U.S.
Communicated sales information and price quotes to western U.S. corporate accounts. Responded to inquiries and proactively resolved customer issues.
Client: MICROSOFT CORPORATION, Redmond, WA Sept 1993 – Sept 1994
Contractor: Rho Technical
One year contract
Supported Latin American Revenue Operations Team
Conducted training programs for temporary agency administrative staff
Assisted with credit and collections functions
Standardized procedures for archiving sales and credit information to improve customer service integrity
After one year of service as a contractor I was approached by management to compete for permanent positions. I declined to return back to the East Coast where my family resides.
Other: * College Co-op at IBM Jet Printer Engineering Laboratory in Glendale, NY
* Marine Wildlife Technician – Grant Position – at Fort Johnson Research Lab, Charleston, SC
* Research Technician Marine Research – Grant Position – at Horn Point Research Station, Cambridge, MD
EDUCATION
Widener Law, Wilmington, DE: Paralegal Certificate in Litigation Candidate; ABA Approved Program GPA 3.75 Graduation: December 2012
Member of Lambda Epsilon Chi – Paralegal Honor Society at Widener Law
Graduate of NAPRX®'s Pharmacology/Pharmaceutical Sales Training Program (June 2009) CNPR Certificate #: 568932009
A.A., Major: Biology Keystone College, La Plume, PA, GPA: 3.2 Dean’s List Student; Secretary and then Vice-President of Kappa Sigma Epsilon
Continuing studies in biology/marine science, math, computer science with credits from: University of New Hampshire Marine Science Consortium, SUNY, USC, The Citadel, & Goucher College, Cumulative GPA: 3.2; Biology GPA: 3.4 Total of 133 credits. 33 credits in Biology.
Career Interests: Regulatory and Information Systems, Legal, International Business/Trade
Completed 7 Habits of Highly Successful People (Franklin Covey).
Member of the National Paralegal Association
Member of RAPS – Regulatory Affairs Professionals Society
References: Please visit my profile on LinkedIn.com for professional recommendations from former colleagues.
Contact this candidate