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IT Manager, Regulatory Information Management

Company Name:
Jacobs Management Group, Inc.
Title: IT Manager, Regulatory Information Management
Location: Raritan, New Jersey or Titusville, New Jersey
Our client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The IT Manager, PM role represents expertise in the organization in the discipline of project, program and portfolio management. Roles in this sub-function are accountable for achieving project objectives, ensuring effective integration of new systems and technologies, meeting time and budget requirements, directing all project resources, and helping the business partner(s) realize the desired business goals for the project(s).This role will assume responsibility and direct accountability for the delivery of various components essential for the success of Regulatory Information Management (RIM) within the company. These components include the Product & Lifecycle Registration System, the Submission Planning, Tracking, and Processing utilities, as well as the future state Document Management System. The incumbent will be expected to possess a clear understanding of integrated, platform technology and work closely with external service providers to ensure delivery of solutions.

Responsibilities include:
Possesses a clear grasp of current Regulatory Information Management (RIM) trends and has a perspective on the future direction of the industry through relationships with vendors, industry peers, and internal business partners and stakeholders
Leads large, moderate to complex projects, programs, or initiatives across the franchise or enterprise (central, regional, and local affiliates, as well as cross-sector)
Builds and manages strong relationships across all IT, legal, finance, and the impacted Business IT areas, etc.
Works effectively as part of a team
Operates effectively in a global environment
Solves complex or unusual problems in consideration of the potential impacts
Negotiates the needs of multiple users or business partners and can adapt to organizational and system complexity and ambiguity
Provides an effective balance between IT standards and strategies and business needs to guide well-informed decisions
Applies compliance requirements within scope of responsibility, provides documentation as necessary, and participates in compliance activities as required

Knowledge should include:
Deep understanding of current RIM technologies and processes associated with conducting regulatory specific activities
In-depth knowledge of all areas of IT and the resources available to deliver projects, programs or manage portfolios
Strong understanding of the current and future state technology and applications with RIM
Advanced knowledge of the strategic plans/initiatives of the Global Regulatory Affairs function or work process area
Knowledge within the Master Data Management (MDM) domain and understanding the importance and framework of effective data governance and stewardship
Understanding of industry defined data standards and associated formats (i.e. EVMPD, IDMP, eCTD, etc.)
Understanding of the business impact of different solutions, and the ability to assess and communicate the tradeoffs between business needs, technology requirements, costs, and risk
Understanding of departmental budgets and the ability to allocate resources accordingly
Understanding of the company's strategic vision and future products, services, and strategies globally
Ability to identify and recover any troubled projects, programs and/or streamline a portfolio

Qualifications:
Bachelor's degree with a minimum of 8 years of relevant work experience OR an advanced degree with a minimum of 6 years of relevant work experience is required
Experience leading large, moderate to complex projects, programs, or initiatives across franchises or enterprises is required
Project management certifications are required
Experience in the pharmaceutical industry is required
Regulatory experience within life sciences is required
Deep understanding of current Regulatory Information Management (RIM) technologies and processes associated with conducting regulatory specific activities is required
Advanced knowledge of the strategic plans/initiatives of the Global Regulatory Affairs function or work process area is preferred
Excellent communication, collaboration and relationship building skills are required

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