Director or Senior Manager or Program Manager

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Director, Senior Manager, Program Manager with 22 years experience looking for a Middle Management position.

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PROFESSIONAL PHARMA EXPERIENCE: May 2001 - January 2010 Johnson & Johnson Pharmaceutical Research and Development, LLC Director, Quality Data Management Benefit Risk Management (BRM) February 2007 - January 2010 * Led design and development of a long-term program for improving global regulat ory drug safety reporting compliance monitoring, scorecard production and dissem ination of quality metrics through new Business Intelligence dashboarding techno logy and process efficiency techniques * Maintained alignment of Quality Systems with PV Alliance Management (3rd party contract) activities; developed a program for identification and impact assessm ent of global regulatory changes that affect drug safety systems * Led early development of a global business continuity plan for BRM by creating the framework for merging three local plans into a single global plan * Represented the BRM Quality Systems group on all global drug safety database p rojects Director, Solutions Maintenance and Support 2007 Benefit Risk Management March 2006 - January

* Led operational aspects of all drug safety system upgrade activities across BR M o Managed planning, communication, time-lines, validation, training, implementat ion, change management, budgets and resources * Developed and maintained System Implementation methodology in order to provide consistent and manageable development and deployment of projects * Provided leadership and direction for the seven member Solutions Maintenance t eam o Managed internal development team resources, time-lines and commitments and co llaborated with functional management to solve cross-system development project resource conflicts * Business Owner for primary safety databases/systems with overall responsibilit y for maintaining system validation and change management activities related to system changes Director, Safety Informatics Drug Safety & Surveillance May 2001 - February 2006

* Successfully led operational aspects of all system activities across BRM inclu ding management of planning, communication, tracking timelines, validation, trai ning, implementation, change management, budgets and resources * Developed, staffed and directed a twenty-four member safety informatics team w ithin BRM * Supervised direct reports to ensure compliance with SOPs, global regulations a nd corporate policies The R.W. Johnson Pharmaceutical Research Institute July 1997 - April 2001

Director, Information Technology Liaison Drug safety & Surveillance Company merged to become Johnson & Johnson Pharmaceutical Research. and Develop ment, LLC. * Directed safety data entry group of six employees * Oversaw operational aspects of all safety system activities across Drug Safety & Surveillance including management of planning, communication, tracking timeli nes, validation, training, implementation, change management, budgets and resour ces

* Designed and developed first web-based global safety report distribution syste m in J&J Knoll Pharmaceutical Corp. July 1989 - June 1997

Manager, Drug Safety 1996-1997 * Managed safety data entry group * Developed internal database systems to promote safety reporting techniques Senior Drug Safety Associate 1995-1996 * Processed complex regulatory safety reports - Cardiovascular case report focus Senior Clinical Research Associate 1992-1995 * Managed clinical trials including identification of prospective sites, budgeti ng, site-set-up, on-site monitoring and final study report development Clinical Research Associate 1989-1992 * Managed clinical trials including on-site monitoring and final study report de velopment Oxford Research International Corp. July 1987 - June 1989

Clinical Research Associate * Managed clinical trials for contract research organization including on-site m onitoring and final study report development KEY LEADERSHIP PROJECTS * Safety Systems Lead during major mergers included change management, data conv ersion, system validation and personnel oversight. o Centocor 2001 o Alza 2004 o Pfizer 2007-2008 * Safety Systems lead for major international safety system customization and de ployment projects which included user requirements development, change managemen t and system validation o Conversion and customization of ARISg 2000-2001 o Development of complex home-grown safety system 2003-2004 AWARDS Encore Award for special achievement for contributions to the Pfizer Healthcare PV Integration Project- 2007 Vision Award for significant contribution to European E2B Reporting Project - 20 06 Standard of Leadership Award for business critical contribution to the SCEPTRE S afety Database Development Project- 2004 Computer Proficiency/ Skills * WORD, POWERPOINT, EXCEL, MS PROJECT, VISIO, Outlook, Sharepoint * Relational database design using good design principles, project management te chniques and CRF Part 11 system validation expertise. * Excellent knowledge of global drug safety regulatory reporting requirements in cluding E2B e-reporting, MEDDRA, Clinical and Post-marketing reporting and aggre gate reporting * Good Clinical Practice and Good Pharmacovigilance Practice expertise EDUCATION University of Delaware Newark, Delaware B.A. Biology, May 1987

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