BACKGROUND

RESPONSIBILITIES

• Collaborating with Subject Matter Experts / Authors and leading the development, revision, and/or obsolescence of compliance and business-related documentation, including Standard Operating Procedures (SOPs), Guidance Documents (GDs), and Supporting Documents. Works with Continuous Improvement Experts, and other groups within SPRI, to facilitate improvements in processes and associated documents.
• Collaborating with the training function on the development of training materials, job aids, etc. associated with SOPs, GDs, and Supporting Documents.
• Placing finalized documents in the appropriate format to meet Schering-Plough Documentation Group requirements. Ensures editorial guideline requirements are achieved and performs Quality Checks on SOPs, GDs, and Supporting Documents.
• Harmonizing timelines with the Documentation Project Manager to ensure that said timelines are achieved.
• Working as the Primary Author for Compliance and Business Documents related to the Global Clinical Document Management System group.
• Performing, of supporting the performance of, the Documentation Administrator Functions. Examples of these activities include, but are not limited to, logging and tracking of Planned and Unplanned SOP Deviations, Document Request Forms, Document Notification Forms, and Impact Analysis Forms; routing SOPs, GDs, and supporting documents for review and securing document approvals, etc. Establishes and maintains documentation hierarchy in secured drives.

REQUIREMENTS

• Suitable candidate should minimally hold a Bachelor-s degree, at least 1-3 years of related Clinical Research or Clinical Operations documentation experience. An advanced degree is preferred.
• Outstanding verbal and written communication skills
• Superior abilities with respect to word-processing systems, such as Microsoft Word, Adobe Acrobat, etc
• Process Mapping Skills (using appropriate software)
• Knowledge of Form Development capabilities, including the ability to translate processes into associated Supporting Documents, such as checklists, templates, etc.
• Experience writing clinical trial documents (preferably SOPs or GDs)
• Exceptional technical writing skills to perform document edits (including SOPs, related documents, and forms) and place the document in the appropriate format (user-friendly).
• Ability to manage the version control (revisions) of documents
• Exceptional overall management and prioritization skills. Ability to manage multiple priorities.

HOW TO APPLY