Document Control Specialist-IIPosted: November 21, 2009
dinaliC is a Philadelphia based consulting firm provides consulting services to major Pharmaceutical companies in US in the areas of Scientific & Research, Clinical, Engineering, Finance & Information Technology fields.
We are hiring for the following contract position for a major Pharmaceutical company in NJ.
JOB DUTIES:
This position will be responsible for the creation, development and maintenance of SOPs and related controlled documents and tools in accordance with GCP, ICH guidelines/requirements and other applicable company guidelines and external regulations. The incumbent will be responsible for the document management process for all controlled documents and providing input into training materials in support of comapny and in accordance with the annual business plan.
Facilitate the overall document management process for both clinical and non-clinical processes, including: Standarized forms and templates for the development of controlled documents; Technical Writing Formatting, Grammar and Quality Check. Ownership and maintenance of the company Glossary; electronic approval of all controlled documents. Storage of all controlled documents; Creation and maintenance of controlled document files and archival of as appropriate. Ownership for the development and maintenance of document development tools, including planning calendar, KPI reports, Table of Contents, etc.
Evaluate new regulatory, compliance and/or legal guidance and develop impact analysis and prepare implementation plans on process, SOP and training as needed. Develop and revise standard operating procedures (SOPs), work instructions and associated forms. Specific responsibilities include: drafts SOPs using SOP WORD template; ensures that SOPs meet all applicable regulatory, financial, and legal requirements and are consistent with the practices of Company, other departments and Corporate and Pharmaceutical Group policies and procedures; coordinates review of SOPs and collect inputs from other SME reviewers; revises documents accordingly and ensures appropriate approval Provides input into training course materials and curricula based on job requirements and changing regulations.
Address compliance audit findings and develop corrective action plans in response. Provide ongoing guidance to CAPA owners to assist them with upholding their observations noted in audits and/or inspections. Track and report on CAPA status.Partners internally with other departments, divisions within company and externally, if required, to obtain best practices and ensure alignment with other internal Company Clinical Service Providers. May represent Clinical Trials Management on GMARCC.
JOB REQUIREMENTS:
BA/BS in biological sciences, nursing or related discipline or equivalent experience is required. A minimum of 5 years experience within a pharmaceutical, biotech, or CRO clinical reserach in an operations group.
In-depth knowledge of GCP, ICH regulations/requirements, and understanding of clinical trials including global trials required. Prior experience in process development is required.
Must have excellent English writing ability and fluency in spoken English. Proficiency is Microsoft office applications (including Word, PowerPoint, and Excel). Please refer to job code DOC001 when responding to this ad.
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