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Tara Dougherty

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Looking for the Right Gig:

Sr. Regulatory Affairs Specialist w exp in Biologics.

Why? REGULATORY AFFAIRS PROFESSIONAL Accomplished Regulatory Analyst with expertise in all stages of drug development and experience in strategy implementation and project management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. * Adept at recognizing and analyzing several therapeutic areas of infectious disease, immunology, anti-inflammatory, and tissue regeneration and engineering. * Set goals, establish priorities, manage resources, and develop strategies to stay abreast of regulatory requirements including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive). * Perform extensive research and analysis to timely and effectively prepare regulatory submissions, with additional emphasis in delivering electronic submissions focused on implementing the eCTD. * Evaluate industry trends and use findings toward designing and executing strategies to boost company leveraging. * Excel at interacting with broad populations, including C-level executives, sales representatives, vendors, clients, contractors, and related stakeholders.
Category: Jobs : Science, Pharma & Biotech
Posted: Over 4 weeks ago in Philadelphia, PA
Description: EDUCATION & PROFESSIONAL DEVELOPMENT

M.S in Quality Assurance and Regulatory Affairs
Temple University, School of Pharmacy, August 2009

Key Courses: Drug Development and Food and Drug Law, Good Manufacturing Practices, Good Clinical Practices, Global Regulatory Affairs, IND/NDA Submissions, Pharmaceutical Project Management, Bioethics, Pre-Approval Inspections, Global CMC and the Regulatory Dossier, Biotechnology and Bioprocess, and Pharmacoeconomics

B.S.in Business Management, December 2004
West Chester University of Pennsylvania

Regulatory Affairs Certification (RAC) Designation (In Progress); Exam scheduled for 2009


PROFESSIONAL EXPERIENCE

Merck & Co., Inc., Ambler, PA (2008-2009)
Informed Consent Specialist
Apply advanced communication skills and industry expertise toward liaising effectively between IRB Project Managers to coordinate submissions of trial protocols and related regulatory documents. Simultaneously steered informed consent forms from Phase I through Phase III clinical trials, demonstrating exceptional multitasking and prioritizing abilities in achieving goals and timelines. Strategically negotiate lay and risk language with clinical sites and institutional review boards, further illustrating strong critical thinking and planning abilities. Proficiently track and maintain regulatory approval dates utilizing Clinical Trial Management System and Cognos Reports, integral to optimizing efficiency and meeting all deadlines.

INC Research, New Hope, PA (2007-2008)
Regulatory Specialist
Served as an integral member of several cross-functional teams, with full accountability for overseeing all aspects of the regulatory document review process and associated timelines for client clinical trial projects and submitting regulatory documents to local and central IRBs. Conducted extensive research and analysis regarding project goals, client objectives, and overall regulatory requirements. Tracked project progress in anticipation of completion dates and ensured effective allocation of resources. Collected and maintained essential regulatory study specific project tracking files and managed clinical monitor scheduled visits to investigator sites.

Tengion, Inc., East Norriton, PA (2006-2007)
Documentation Control Specialist
Consistently received an annual bonus due to exceptional performance and dedication in meeting company objectives and expectations. Strategically developed and implemented a streamlined, highly efficient document control system instrumental to boosting productivity. Relied upon to oversee, maintain and update all quality documentation including standard operating procedures, department policies, clinical batch records, protocols, and vendor audits. Invited to join as a key member of a project management team involved in implementing an electronic document control software program to effectively organize and streamline the management of quality management documents.

Additional Employment: Document Control Associate for Cephalon, and Regulatory Archive Assistant for Centocor.


TECHNICAL SKILLS & AFFILIATION

Major software programs used in pharmaceutical and biotech industries, including: Documentum, Impact CTMS, Cognos Reports, Project Trend, Qumas, Microsoft Word, Excel, PowerPoint and Access, and Adobe Acrobat.

Member, Regulatory Affairs Professional Society (RAPS)
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