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Job Title: Senior Clinical Documentation Specialist - Medical...
Job Location: NJ: Kenilworth
Pay Rate: Open
Job Length: full time
Start Date: 2008-08-13

Company Name: Schering-Plough
Contact: HR
Phone: email only please
Fax: email only please

Description: Position Title Senior Clinical Documentation Specialist - Medical Communications Business Division Research Institute Country U.S.A. Location NJ Kenilworth Job Description This position is intended to support and manage the clinical content document management throughout Medical Communications. Critical Tasks include: · Support of Clinical Trial Registry and Results posting activities (e.g., editing and adding protocol registry information). · Support of clinical trial management system entry and QC of study and submission data. · Serve as Subject Matter Expert (SME) on business aspects of various document management systems. · Serve as SME (representative lead users) on cross-functional business teams. · Major activities include: · Collection, distribution and storage of all Quality Verification forms and signatures associated with all Medical Communications documents (Clinical, ECREM, GPV). This includes tracking and contacting various sources for originals and completing the packages submitted to Clinical Documentation. · Management and distribution of Medical Communications electronic documents (applying document securities and watermarks, electronic burning of CDs, posting on Intralinks, e-Room, and SharePoint and providing Clinical with documentation for investigators). · Document management and maintenance of secure document exchange workspaces to support GPV and Clinical Operations and Clinical Research. · Management of documents submitted to Clinical Documentation (e.g., Country Operations, CRO/Vendors, and JV license partners). This includes scanning, electronic filing of documents, and applying the appropriate attributing and QC. · Content organization and preparation of all Investigator and IRB lists for clinical study reports. · Management, editing, reviewing, and updating of all Medical Communications document templates. · Document Management System Business Administrator (SP DOORS) responsibilities (notification list updates, dictionary maintenance, obsolescing, and deleting of documents, edit and author workflow management). · Creation of new folders (attributes of files) in document management system in order for Medical Writers to begin working on a document. · Maintenance of departmental standards and documentation for file storage and attributing. · Participate in Clinical and GPV teams pertaining to document management, storage, distribution, and tracking. · Project management and compliance (supporting such activities as program and submission tracking, providing support, documents, project management reports, etc.). · Lead Users for Clinical and GPV for document management systems (serve as key points of contact for cross- departmental document management activities and serve as key representatives with GRA Operations publishing activities). Additional responsibilities may include: * Support and preparation for audits and inspections. * Maintenance of department Style Guide. * Project management and team support of all document management-related projects throughout Medical Communications. * Provide training on document management software processes and regulations.

Minimal education required for this job Bachelors Degree -- Any Skills REQUIREMENTS: . Bachelors degree and 5 years Pharmaceutical experience or equivalent 8-10 years Pharmaceutical experience and a minimum of 5 years document management experience which should include: A Clinical Trial Management system, SharePoint and / or Interlink or a comparable document exchange system. . Experience with Arrow-International is a plus. . Proficiency with Adobe Acrobat and Microsoft Office. . Strong word-processing skills. . Proficient in scanning and electronic document management - Documentum based. . Strong organizational, interpersonal, and written/oral communication skills. . Should be quality minded, with the ability to work cross-functionally, interacting with Reg Affairs, Pharmacovigilance and Clinical. Experience with insuring compliance is a plus. . Management and supervisory skills preferred. . Leadership experience preferred. . Ability to manage multiple simultaneous diverse responsibilities. . People skills - ability to work well with a diverse group of personalities, team player, flexible and adaptable Planning, managerial and organizational skills, ability to prioritize and execute. Employment Type Regular Full- or Part-Time Full-Time Work Schedule Day Requisition I.D. 22410BR

Please refer to Job code schering-889642 when responding to this ad.

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