Manager Project
Resume:
Penny Wollum, RN, MS
San Diego, California 92117
abndro@r.postjobfree.com
Thirteen years of regulatory affairs experience with successful outcomes in
the device, drug and combination products arenas. Demonstrate proficiency
of interpretation and implementation of regulatory requirements. Six years
of experience as an RN Study Coordinator with a variety of protocols in
different therapeutic areas. Twenty years of clinical nursing and nursing
management experience.
My solid background in drug and device development and in clinical trials
gives me the ability to effectively manage the complexities involved in
these challenging areas.
EDUCATION
M.S. in Regulatory Affairs, 2001
San Diego State University
San Diego, California
B.S. in Business Administration, 1998
University of Phoenix
San Diego, California
A.D. in Nursing (RN), 1974
Kalamazoo Valley Community College
Kalamazoo, Michigan
EMPLOYMENT
Well demonstrated ability to effectively lead teams to meet deadlines and
provide quality submissions. Able to provide successfully audited
materials and continually meet company goals.
Labyrinth Regulatory Consulting
San Diego, California
Owner/Consultant
February, 2008 - Present
. Develop strategies for regulatory and clinical programs
. IDE/IND/CTA regulatory submissions (US, Canada, and EU)
. IRB/EC submissions
. 510(k) submissions
. Write protocols, informed consents, patient information leaflets,
Investigator's Brochures, Instruction for Use materials, clinical
study reports
. Developed SOPs for regulatory and clinical departments
. All "routine" regulatory submissions (annual reports, amendments,
meeting requests)
. CRF design
. Client teaching regarding GCP; safety reporting; overall clinical
trial compliance
PRA International
San Diego, California
Regulatory Services Manager II (Senior Manager)
February, 2007 - February 2008
. See PRA International responsibilities listed below for February, 2004
- June 2006
Angiotech Pharmaceuticals
Vancouver, Canada
Regulatory Affairs Senior Manager
June 2006 - January 2007
. Managed US and EU regulatory submission projects for drug, device,
and drug/device combination products
PRA International
San Diego, California
Regulatory Services Manager
February, 2004 - June 2006
. Project management for regulatory consulting and regulatory
submission projects
. Developed program strategies, clinical protocols, project plans,
etc.
. Ensured project team fulfilled their project responsibilities in
accordance with contract and SOPs
. Ensured projects were delivered on time, within budget, and
according to client expectations
. Provided regulatory expertise for client projects, as primary
consultant or as internal resource for regulatory and other project
team members
. Frequently asked to give teaching presentations to both internal
staff and external clients
. Consulting services - strategy, due diligence, scientific review,
clinical trial planning
. Regulatory submissions - IND, CTA, submissions,
supplements/amendments, etc.
. Agency/authority interactions for projects - Pre-IND, End of Phase
2, Pre-NDA, etc.
SkyePharma Inc.
San Diego, CA
Regulatory Affairs Manager
January, 2003 - December, 2003 (company downsized; layoffs)
. Liaised with regulatory agencies for all product/project-specific
issues
. Responsible for one drug product in Phase 2/3 and one postmarket
product with Phase 4 and pediatric trials
. Wrote NDA Supplements
. Compiled IND, NDA, and PSUR annual reports
Advanced Tissue Sciences, Inc.
San Diego, CA
Regulatory Affairs Manager
April, 2001 - November, 2002 (Company filed Chapter 11)
. Assisted with strategic planning for biologic and medical device
product development
. Liaised with regulatory agencies for biologic and device products
. Compiled pre-IND meeting packets
. Successfully wrote HUD designation request
. Assisted with PMA submission
Quintiles Pacific, Inc.
San Diego, CA
Regulatory Scientist I (Medical Writer)
January, 2001 - April, 2001 (Regulatory Department relocated)
. Assisted in the writing of Clinical Study Reports for 3 NDA filings
. Assisted in writing manuscripts for medical journal publication
Pacific Regulatory Services, Inc.
San Diego, CA
Regulatory Affairs Manager
March, 1997 - December, 2000
. Assisted with preclinical strategy development for biologic stem
cell product
. Wrote IDE for Class 3 cardiac device
. Updated and created SOPs for clinical trial management and database
management
. Wrote and reviewed preclinical plans, clinical investigation
protocols, Investigator's Brochures, informed consent documents
. Wrote biocompatibility "white paper" resulting in being able to
forgo long-term carcinogenicity and chronic toxicity testing in the
development of a device
. Developed case report forms
. Wrote Premarket Notifications [510(k)s]
. Experiences included IDE and PMA submissions
Parexel International Corporation
San Diego, CA
Clinical Data Manager
June, 1996 - March, 1997
. Developed Data Handling Documents and CRF Instructions
. Generated queries from CRF review and integrated query resolutions
. Conducted database audits
. Coded adverse events and concomitant medications
Scripps Clinic and Research Foundation
La Jolla, CA
Coordinator, Inflammatory Bowel Disease Center (Clinical Trial
Coordinator)
1992 - 1996
. Responsible for all on-site aspects of clinical trials, including
recruitment, IRB submissions, and budgeting
. Wrote and submitted protocols for drugs developed in-house
. Involved in obtaining basic research grants for Crohn's and colitis
projects
Scripps Clinic and Research Foundation
La Jolla, CA
Staff Nurse - General Clinical Research Center
1990 - 1992
. Oversaw daily administration of individual protocols
. Did extensive work with hematology studies involving
immunosuppressive chemotherapeutic agents, multiple sclerosis
studies, enzyme replacement studies, allergy studies, and orphan
diseases
VillaView Hospital
San Diego, CA
Department Manager
1989 - 1990
Responsible for management of Medical Surgical and Coma Units
Scripps Clinic and Research Foundation - Green Hospital
La Jolla, CA
Charge Nurse
1986 - 1989
. Oversaw daily operations of Cardiac Telemetry and Step-down Units
Borgess Medical Center
Kalamazoo, MI
Manager and Staff Nurse
1974 - 1985
Worked in various cardiac units including Cardiac Rehab, Cardiac Cath
Lab, Nuclear Cardiology, and Cardiac Telemetry Unit
THERAPEUTIC EXPERIENCE
. Allergy
. Anesthetic agents
. Cardiovascular
. Dental
. Gastrointestinal
. Hematology
. Neurology/CNS/Spine
. Oncology
. Wound-healing
CERTIFICATION/LICENSURE
. California R.N. License - Kept current
. ACRP Certification for Clinical Research Coordination since 1994
(CCRC) - Kept current
PROFESSIONAL AFFILIATIONS
. Associates of Clinical Research Professionals (ACRP)
. San Diego Regulatory Affairs Network (SDRAN)
. Southern California Pharmaceutical Medicine Group
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