Skills Required:
1. Content Management
2. Requirements assessments at enterprise level
3. CDISC, Drug Safety, cGxP
4. Sharepoint or Documentum
Ideal candidate will have been a significant business process and technical contributor to an enterprise (or, in a large company, divisional) document or content management system, with experience in: researching technology differentiators; technology/architecture selection/development; requirements assessment and development at the enterprise, departmental, and functional levels; governance model support; organizational change support; phased implementation planning; training; implementation, ongoing technical and business process support. Ideally, candidate will also have significant knowledge of and experience with one or more of the following: CDISC requirements, regulatory filings, product/portolio management, drug safety, cGxP, system validation requirements and contract management business processes. Candidate should also have hands-on experience with system implementation projects and all of their requisite phases and tasks.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Incumbent will interact with all levels of the organization in the development of requirements documentation for document and content management.
2. Incumbent will work with internal and external business and technical staff in the development of an EDM governance model.
3. Incumbent will work with internal and external business and technical staff in the development of an overall system architecture and the selection of optimal technologies for the solution.
4. Incumbent will be experienced in ongoing change management incorporation of new business processes and associated content in the context of an enterprise content management system.
5. Incumbent will also be the IT analyst responsible for all matters pertaining to document and content management in all areas of the business.
6. Incumbent will author policies, procedures, validation documentation, and other documents pertaining to the governance, administration, validation, and management of document/content management systems.
7. Incumbent will work with Regulatory and Clinical groups in the development and implementation of enabling solutions for their content management and publishing needs.
8. Incumbent may ultimately be responsible for the recruiting and management one or more junior analysts.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1. Bachelor of Science Degree in an IS related field. Advanced degree preferred.
2. Four to seven years experience in FDA-regulated industry, working on the specification, development, implementation, and administration of computerized systems in a cGxP environment.
3. At least 4 years experience in working with an entrprise-class document or content management system in a support role.
4. Direct involvement in the development, implementation, and maintenance of a governance model for ED/CM system strongly preferred, as is experience in technology evaluation and selection. 5. Significant experience in the development and execution of computer validation documentation highly preferred, as is experience in the development and maintenance of procedures.
6. Experience assisting in the development of training requirements, and in the training of users in a computerized system is a significant advantage.
7. Excellent verbal and written communication skills are essential for this position, as are excellent documentation habits.
8. Must be self-motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
9. Sharepoint and/or Documentum experience a significant plus. FirstDoc experience a plus.
Travel Requirements : Up to 10% |