Manager Quality Control
Resume:
LYNNE L. HALLMAN
Pottstown, Pennsylvania 19464
Email: abm5dw@r.postjobfree.com
PROFESSIONAL QUALIFICATIONS
More than twenty-five years of experience dealing effectively with clinical
and regulatory issues using demonstrated skills in:
- Ability to distill complicated technical information and organize it
into understandable format.
- Strong interpersonal and communication skills, contributing to
ability to relate well to individuals at
all levels of corporate structure.
- Outstanding report writing techniques.
- Keen analytical mind, coupled with effective problem solving skills.
- High levels of creativity and flexibility.
PROFESSIONAL EXPERIENCE
PROTALEX, INC., New Hope, Pa Nov 2007 to Jul 2008
Clinical Research Associate
. Prepared protocols, CRFs, informed consents and submission-related
documents.
. Prepared sections of the investigator brochure.
. Tracked inventory of all clinical supplies.
. Managed CROs in the conduct of clinical trials.
WYETH RESEARCH, Collegeville, Pa Sep 2000 to Oct 2007
Senior Clinical Scientist, Medical Research Neuroscience
. Prepared protocols, CRFs, informed consents, and submission-related
documents for Phase I, II and III clinical trials.
. Lead the study team and provide training and support to regional staff.
. Liaised with European and North and South American regional clinical
staff in the planning, implementation and monitoring of international
clinical trials.
. Coordinated drug supply, processing of serious adverse event reports and
prepared safety updates for regulatory agencies.
. Worked closely with operational trial management personnel on conducting
trials.
. Reviewed clinical trial data using electronic monitoring tools, and
resolved data issues.
SANOFI-AVENTIS PHARMACEUTICALS, Collegeville PA Sep 1999 to July 2000
Manager, Respiratory Medicine
. Managed all aspects of multiple, outsourced clinical studies within an
overall clinical program.
. Developed protocols, CRFs, informed consents, and budgets.
. Coordinated drug supply and managed all interactions with CRO.
. Ensured consistency throughout the overall clinical program and clinical
project in conjunction with other study manager.
ASTRA-ZENECA PHARMACEUTICALS, Wilmington DE Nov 1995 to Sep 1999
Senior Clinical Research Associate, Pulmonary
. Prepared protocols, CRFs, informed consent, and budget for Phase IV
clinical trials.
. Initiated, monitored, and closed out sites.
. Coordinated drug supply and overall trial management.
. Coordinated all aspects of a 2000 investigational site, Phase IV clinical
trial through three CROs and facilitated cooperation and communication
between the three CROs and with Zeneca Study Team members.
LYNNE L. HALLMAN
Page Two
INDEPENDENT CONSULTING May - Nov 1995
Clinical Trial Management, B. Braun Medical, Bethlehem, PA
. Abstracted information from patient hospital records at Tampa General
Hospital to complete case records of a triple lumen catheter study.
. Coordinated all aspects of record collection with hospital staff
WEST PHARMACEUTICAL SERVICES, Lionville, PA Jan 1977 to Feb 1995
Manager, Regulatory Affairs (1990-1995)
. Maintained current awareness and provided general policy and planning
recommendations relative to regulatory considerations to management and
other groups within the company and established regulatory policies,
goals, procedures and a highly favorable working relationship with FDA
personnel.
. Invited by the Deputy Director of CDER, to join a project team of FDA
personnel, to evaluate the automation of Drug Master Files through
computerization.
. Met with and provided information to the Pharmaceutical Evaluation Group
of Canada's Health Protection Branch on the magnitude and potential
impact of a proposed regulation on nitrosamines in pharmaceutical rubber
products. Result was a withdrawal of the proposed regulation for further
review and investigation.
Regulatory Affairs Administrator (1985-1990)
. Maintained master files with FDA and foreign regulatory bodies.
Established master file systems in Canada and Australia.
. Responded to inquiries and provided information, assistance, and advisory
recommendations to customers to facilitate regulatory approval of their
products.
. Provided all necessary assistance for foreign drug registrations through
counterparts at affiliates and subsidiaries worldwide and provided
regulatory advice and support to other internal groups.
Regulatory Affairs Coordinator (1981-1985)
. Prepared and assisted in establishing Hazard Communication program for
company in order to meet legal requirements of Occupational Safety and
Health Administration (OSHA) Hazard Communication Rule, including
acquiring and collating all necessary information and creating of
computer database to provide necessary documentation to trainer. Project
completed on schedule and in addition to performing primary
accountabilities.
. Prepared submissions to and maintained master files and supervised
generation of data necessary for regulatory submissions and provided
information requested by customers in meeting regulatory requirements.
Senior Technician, Quality Control Laboratory (1977-1981)
. Evaluated raw materials, both new and alternate sources and prepared
reports.
. Completed special projects involving solving problems with raw materials
and finished goods.
EDUCATION
Eastern University, St. Davids, PA - BS Biology, 1977
Researched and prepared thesis entitled "Effects of Sound Stimulation on
Rodent Reproduction"
Continuing Education:
. Drug Product Stability and Shelf Life - CPA
. International Comparative Drug Regulatory Systems - CPA
. Drug Development Workshop - RAPS
. Food and Drug Law graduate course, Temple University
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