Regulatory and Project Manager - Biotech Resume Search
Regulatory and Project Manager - Biotech Resume Search
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Regulatory and Project Manager Resume


Desired Industry: Biotech SpiderID: 10715
Desired Job Location: Baltimore, Maryland Date Posted: 1/12/2007
Type of Position: Full-Time Permanent Availability Date: 01/17/07
Desired Wage: $55,000
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Bachelors Willing to Relocate: Undecided


Objective:
To contribute my expertise in regulatory compliance and project management to a growth-oriented company


Experience:
Protocol Monitor / Data Manager June 2004 to December 2006
The EMMES Corporation Rockville, Maryland

Collaborate on the development and management of national and international clinical trials.
Responsible for all facets of protocol management across multiple sites and studies.
Conduct regular site visits to external locations to ensure compliance with regulations and protocols.
Collaborate with internal and external committees and sponsors regarding project goals and activities.
Develop and contribute to protocols and reports in collaboration with internal team and external sponsor.
Develop Standard Operating Procedures, Manuals of Procedures, User Guides, and Data Entry Guidelines.
Collaborate on project audits including review, response, and remedial action plans.
Serve as project liaison between clinical sites, internal teams, and project sponsors.
Process adverse events and serious adverse events, reporting to FDA and other agencies as appropriate.
Develop training curriculums and conduct regular educational sessions for project personnel.
Collaborate with Internal Review Board to review, develop, and submit annual renewal documentation.
Develop and maintain tracking systems for regulatory documents and clinical site information.
Create Internet screens and associated database systems to collect information from remote sites.
Collaborate with internal team to develop and test database platforms and systems.
Develop queries, crosschecks, and reports to locate anomalies and ensure integrity of project data.
Review data submitted, assess adherence with requirements, and grant or deny requested exceptions.

Administrative Coordinator January 2004 to June 2004
The EMMES Corporation Rockville, Maryland

Coordinate meetings, conferences, and events for individual projects as well as corporate groups.
Develop and maintain project website to include rosters, calendars, and links to external sites.
Schedule and manage project activities, deadlines, and resources for internal team.
Assist with the development, routing, and submission of project manuscripts for review and publication.
Create and maintain tracking systems for data and documents in both electronic and hard copy formats.
Develop and distribute site visit documentation, schedules, information, and reports.
Collaborate with internal team and outside vendors to develop and distribute specialty publicity items.

Coordinator / Resource Manager (E.S. II) - June 1999 to December 2003
Doctors Community Hospital Lanham, Maryland

Conduct analytical evaluations of state and federal legislation, including HIPAA and JCAHO regulations.
Interpret legislative guidelines to assess applicability to facility and assist with development of action plans.
Conduct analytical comparisons of Federal and state legislation to determine organizational compliance.
Review and develop policies/procedures, and practices to ensure compliance with state/federal regulations.
Create survey instruments, collect and analyze data to design and implement processes and systems.
Develop correspondence, reports, and promotional materials such as newsletters, brochures and posters.
Organize and maintain on-line library of informational materials. Monitor and control user access.
Maintain educational database for employees to track training, statistics, seminars, CEUs, etc.
Collaborate with committees, such as Documentation, Web Development, and Employee Retention.
Coordinate events, including facilities, vendors, participants, travel/lodging, testing and documentation.
Awards Presidential Award (2001, 2000 and 1999) and Quality Recognition (2000 and 1999)

Executive Assistant / Office Manager (E.S. I) - May 1996 to June 1999
Doctors Community Hospital Lanham, Maryland

Serve as patient liaison to ensure customer satisfaction and prompt handling of patient issues.
Act as public relations representative for the Nursing Administration department.
Perform duties as Notary Public and assist patients, family members and staff with legal documents.
Coordinate events, including facilities, vendors, participants, travel/lodging, testing and documentation.
Coordinate and participate in fund-raising and publicity events to promote facility to community.
Maintain all policy and procedure manuals and other pertinent records of department.
Develop correspondence, reports, meeting minutes, and other documents for Vice President and Directors.
Awards Presidential Award (1998, 1997), Employee of Month (1996), Quality Award (1998, 1997, 1996)

Administrative Assistant July 1994 to May 1996
National Naval Medical Center, Internal Medicine Bethesda, Maryland

Prepare and distribute requests, consents and paperwork to proper departments and/or clinics.
Prepare correspondence and miscellaneous documents for department.
Contact physicians and/or appropriate health care professionals as necessary.
Verify proper documentation on medical administration sheets, pharmacy records, etc.
Transcribe physician orders involving patient activities, diets, tests and medications.
Award Certificate of Special Achievement (1995)


Education:
* Masters of Business Administration University of Maryland University College
* Masters of Health Care Administration University of Maryland University College
* Bachelor of Arts Jurisprudence (Pre-Law) University of Baltimore (2002)
* Associates of Applied Science Business Management - Anne Arundel Community College (1998)


Affiliations:
American Notary Public Association (1996 to 2002)
University of Baltimore Jurisprudence Association (1999 to 2003)
Regulatory Affairs Professionals Society (2005)


Skills:
* Project Management
* Regulatory Compliance
* Data Management
* Quality Assurance
* Legislative Analysis


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