Regulatory Affairs Manager or Sr. Specialist - Biotech Resume Search
Regulatory Affairs Manager or Sr. Specialist - Biotech Resume Search
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Regulatory Affairs Manager or Sr. Specialist Resume


Desired Industry: Biotech SpiderID: 57071
Desired Job Location: Philadelphia, Pennsylvania Date Posted: 1/17/2012
Type of Position: Full-Time Permanent Availability Date: 01/17/2012
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Masters Willing to Relocate: Yes


Objective:
I am a Clinical Research and Regulatory Affairs
professional with 5 years of experience in the
Pharmaceutical and Biotechnology industries. My
strengths include negotiation, problem solving and
benefit-risk analysis. I have specific expertise in
Electronic and Paper Regulatory Document
Management, Regulatory Submissions (i.e.
Investigational New Drug, New Drug Application,
Biologic License Application and the Electronic
Common Technical Document or eCTD), Multiple
Study Site Startup requirements and IRB liaison. I
am seeking an opportunity where I can help bring
high quality effective medicines to market while
making them safe for the global population.


Experience:
ClinForce, LLC, Ambler, PA 2008 - 2009
A National Clinical Research Employment
Organization which matches Clinical Research
professionals with reputable Pharmaceutical and
Biotechnology companies Developed vaccine and
HIV/AIDS products for Merck & Co., Inc. Reviewed
documentation for regulatory compliance with GCP
regulations and human subject protection
guidances.

Patient Informed Consent Specialist
Managed, reviewed and audited domestic and
global informed consent forms required to start up
clinical studies for a 30 billion dollar Pharmaceutical
company. Improved the number of approval
outcomes to begin and amend clinical trials that
met strategic, financial, and customer objectives.
Utilized Documentum and Microsoft Word to
scientifically write, review, edit and deliver ethical
and approvable consent forms ahead of the
customers deadline expectations of 5 working days.
Successfully negotiated lay language in 15 domestic
and globally formatted consent forms with board
members of central and local IRB/IECs conforming
to both parties internal policies and regulatory
requirements.
Streamlined the new hire training program reducing
the time to train new hires by 50%.

INC Research, New Hope, PA 2007 - 2008
A global and therapeutically focused Contract
Research Organization that conducts Phase I
through Phase IV clinical development programs for
Pharmaceutical and Biotechnology companies using
their Trusted Process® to bring products to market
in order to improve world health. Acted as an
advisor for clients to provide regulatory affairs
compliance strategy for clinical trials.
Regulatory Specialist
Persuaded clientele to migrate from paper trial
master files to an eTMF Documentum based storage
saving the need to store paper in an archive room.
Tracked trial progress in anticipation of planned
start and completion dates ensuring client
objectives were met.
Coordinated, prepared and reviewed investigator
documentation for submission to central IRBs 
and
regulatory binders for local site investigators.

Tengion, East Norriton, PA 2006 - 2007
A 300 Million dollar venture capital biotech startup
in with a one of a kind regenerative medicine
product designed to help those with spina bifida
and organ failure. Helped Quality Assurance setup
a pilot manufacturing facility at Corporate
Headquarters. Successfully selected a new
electronic document management software system
to the company change to electronic
documentation

QA Document Control Specialist
Researched, Presented and Implemented a
controlled documentation system both electronic
and paper which created inspection readiness and
reduced change control timelines.
Advised senior management of documentation
issues and provided practical solutions to remain in
compliance with cGMP regulations and Good
Document Practices guidelines.
Reviewed Manufacturing and Quality Assurance
documents such as Standard Operating Procedures,
Quality Control specifications, test methods,
protocols and batch records for proper format and
compliance to internal company standards and
external documentation guidelines.
Received a 3% annual bonus due to exceptional
performance and dedication in meeting company 

objectives and departmental expectations.

Aerotek, West Chester, PA (Temporary Assignment)
2006 - 2006
Contracted with a $2.8 Billion dollar Biotechnology
company in the development of central nervous
system, pain and cancer products for the US
domestic and international markets. Provided
consulting services to the Regulatory Operations
department in controlling and managing electronic
documents per 21 CFR Part 11 requirements.

Regulatory Document Associate
Assisted special task force in the migration of
documents into the client's electronic document
management system (EDMS) from a paper based
system.
·  Trained new users of the EDMS software system
using a hands on style of training.
·  Transferred legacy documentation into electronic
format along with Cephalon’s objective to manage
documents over multiple locations throughout the
US.

Kelly Services, Malvern, PA (Temporary Assignment)
2005 - 2006
Contracted with a multi-national pharmaceutical
company in an effort to develop a new Global
Regulatory Submission Information Library.
Migrated old legacy global submission archive into
a new electronic submission repository.
Assisted project team in the development of an
electronic Regulatory Information Library and the
migration of paper submissions to an electronic
archive.
·  Scanned global regulatory submission documents
and correspondence into an Adobe PDF file for
electronic storage in the Documentum based
electronic archive.·
Assessed the training needs for the new electronic
archive library eventually revamping the current
training processes to implement training on the
new electronic system.


Education:
M.S. - QA/RA, Temple University, Philadelphia, PA
2009
B.S. - Business Management, West Chester University,
West Chester, PA 2004


Skills:
clinical research, regulatory affairs, document
management, research & development, project
management, business management principles,
motivation, organization and leadership


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