Manager of IT/ Drug Safety

Our client, located in Bridgewater NJ is seeking a Manager of IT / Drug Safety for an immediate full-time position. Details include:



An ideal candidate will work within and across the program work streams with a primary role of executing business analysis and project management activities for technology projects being implemented for the Drug Safety department. This candidate should have managed or been a part of implementation teams for Drug Safety Systems preferably with Arisg/j safety system. Other highly valuable skills needed are: Knowledge of Drug Safety business practices and hands on experience in configuring reports in safety system; Planning for phased project implementations, training, providing ongoing project support knowledge of validation activities, test script creation & 21 CFR Part 11 knowledge.

RESPONSIBILITIES:
Incumbent will have a primary role of executing hands-on business analysis and application configuration activities as defined below:

1. Partner with internal customers to gather, refine and evolve business requirements; translate business requirements into user requirement specifications; translate user requirement specifications into functional requirements.

2. Support IT solutions based on the business knowledge while demonstrating core competency in Drug Safety technology implementation business and a strategic approach to meeting business objectives.

3. Collaborate with implementation and delivery teams to communicate, evolve and modify functional requirements as projects need(s) change.

4. Prepare validation documentation including writing of test scripts for systems and use case scenarios for user acceptance testing.

5. Ability to configure and modify reports for business in the Drug Safety application.

6. Develop trade-offs and options using strong analytical skills to assist management in decision making as well as to gain stakeholder alignment and approval of requirements.

7. Prepare simple to complex project plans using project planning software and oversee activities in the project plan to completion.

8. Work in a team environment with internal and external technical staff in the development and implementation of system architecture and assist in the selection of optimal technologies for the solution.

9. Thorough knowledge of SDLC methodology and knowledge of project management practices.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1.Bachelor of Science Degree in an IS related field. Advanced degree preferred.

2.At least 5 years experience in FDA-regulated industry preferably managing and configuring safety applications for Drug Safety (ARISg), working on the specification, development, implementation, and administration of computerized systems in a cGxP environment, and 21 CFR Part 11. Knowledge of FDA, EMEA regulations for E2B communications set up using technology solutions.

3.Direct experience in the evaluation, development, and implementation of technology projects for the Drug Safety organization. Highly desirable is the experience to configure Safety reports and assist in application administration.

4.Significant experience in the development and execution of computer validation documentation highly preferred.

5.Experience developing project plans and managing small projects for cross-functional teams is a significant advantage and highly desirable.

6.Excellent verbal and written communication skills are essential for this position in addition to excellent documentation skills.

7.Must have an ability to work effectively and efficiently both independently as well as in a team environment.

8.Must be self-motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.

9.Ability to collaboratively work with cross-functional, multi-disciplinary teams on multiple, concurrent project initiatives.