DePuy Synthes, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Director, Regulatory Affairs Global Knowledge Management. This position can sit in multiple locations such as: New Brunswick or Somerville NJ, Raynham MA, Cincinnati OH, Warsaw IN, Irvine CA or Jacksonville FL.
http://www.careerbuilder.com/job/J3F0PG6PN1GYC4KRMQG
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Director, Regulatory Affairs Global Knowledge Management will be:
Responsible for creating and executing the strategy to drive an integrated cross MD RA information “super highway” through the establishment and implementation of technology solutions that will enable global communications, reporting and analysis to accelerate and maximize the success of obtaining product registrations and supporting the lifecycle management of all MD products from across multiple business units globally.
- Works with technology professionals and managers to develop technology solutions that meet Regulatory Affairs clients’ requirements. Directs, develops, and presents to management various analyses (for example, organizational, systems, feasibility, and cost/benefit studies, implementation plans)
- Interacts extensively with business partners to provide technology solutions; developing strong relationships with business partners and staff to develop solutions
- Exercises a high level of judgement and execution anticipating, interpreting, evaluating and resolving complex organizational opportunities while appreciating the direct impact on the operational results of the business. Decisions impact portfolio and help shape long-term strategies
- Educates and informs business management on emerging/specialty strategic technologies
- Oversees the implementation of technology solutions to meet requirements
- Anticipating conflicting needs and proactively resolving them
- Ensuring that projects are on time, on budget and meet the needs of the business
- Integrate information solutions across technologies, platforms, systems
- Ensure resources and organization structure are in place and operating effectively
- Managing business partner expectations on which projects will be funded and resourced
- Identifying funding sources for priority projects
- Integrating resources effectively, including resources under the direct control or controlled by contractors, vendors etc.
- Determines the staffing levels, skill sets, and the job and organization structure needed to achieve the work plan implemented changes
- Addresses unusual and non-recurring problems by devising approaches to assess the situation, evaluating options, and introducing by new procedures or tools, as necessary
- Assess current business process flows, identify opportunities for technology solutions to optimize organizational effectiveness
- Addresses novel organizational challenges by helping staff navigate the organization effectively and resolving the diverse perspectives of multiple stakeholders
- Develops all resources and manpower plans for the area. Continually improves work procedures and processes for unit(s) managed
Qualifications
- A minimum of a Bachelor’s degree in a Science or Business related field is required; OR an advanced degree (MS, MBA, PharmD, PhD, MD) is preferred
- Minimum of 10 years’ relevant experience in a regulated industry is required
- Understanding structure based background understand regulatory language is required
- Supervisory/talent development experience or leading projects with indirect influence is required
- Experience with document management systems and portfolio/project management systems is preferred
- Regulatory Affairs experience is strongly preferred
- Leads the development of effective networks with internal/external business partners as well as collaborates with senior technical colleagues on assessments and evaluation of new technologies is required
- Excellent ability to build and maintain relationships and quickly build credibility at all levels in the organization is required
- Proven experience working within health care regulatory environment in one of the following areas: Medical devices, pharmaceuticals or consumer products is preferred
- Highly skilled in establishing partnerships within function, successfully influence senior leaders and able to work collaboratively in a highly matrix environment is required
- A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously is required
- Ability to achieve results under demanding time constraints with expansive and changing priorities is preferred
- Demonstrated ability to attract, retain and develop talent is preferred
This position can sit in multiple locations such as: New Brunswick or Somerville NJ, Raynham MA, Cincinnati OH, Warsaw IN, Irvine CA or Jacksonville FL and may require up to 25% Domestic and International travel is required.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Primary Location
United States-New Jersey-New Brunswick
Other Locations
North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Florida-Jacksonville, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Somerville
Organization
Johnson & Johnson (6067)
Job Function
Regulatory Affairs
Requisition ID
6230170327
