Business Process Management and Aggregation Director (Regulatory Affairs)
Location:
, Pennsylvania
Posted:
June 24, 2016
Reference:
REG002428
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Business Process Management and Aggregation Lead is accountable for the delivery of a global, enterprise system that enables Global Regulatory and Clinical Safety (GRACS) key processes and provides organizational visibility of regulatory and safety information assets through aggregation. The Lead is responsible for strategies that expand the business process/workflow capability in order to improve overall process compliance, simplify process execution, and eliminate redundant data entry across business capabilities. The incumbent will develop strategies that establish an information aggregation capability and will have responsibility for the execution of that strategy. Responsibilities include but are not limited to:
  • • Develop and manage the business process/workflow management and aggregation capability strategy across the information domains within GRACS
  • Communicate the business value of business process/workflow management and aggregation; influence key stakeholders to ensure support for the defined strategy
  • Lead strategies that enable the Global Submission Operating Model (GSOM); and related portfolio planning and submission management activities through use of the business process/workflow capabilities
  • Lead strategies that enable our business performance management measures through process metrics collected in the business process management/workflow capability
  • Collaborate with senior stakeholders within GRACS and across the divisions (MRL, MMD, GHH) in relation to business process/workflow management and achieve alignment and efficiencies
  • Drive alignment of GRACS aggregation capability needs across the Business Process and Information Management capabilities (ie. submission planning, health registration management)
  • Drive innovation into the business process/workflow management and aggregation business capability both through internal and external input
  • Collaborate with MRL IT on setting the strategy for the business process/workflow management and aggregation capabilities for GRACS
  • Collaborate with Business Process Leads/Owners to identify processes that would benefit from business process/workflow management enablement
  • Incorporate mobile device usage into the business process/workflow management and aggregation layer capability strategies
  • Align business process/workflow management and aggregation activities with the overall GRACS information management strategy
  • Drive continuous improvement into our business process/workflow management capability through iterative refinements and identifying new opportunities
  • This position can be located in either Upper Gwynedd, PA or Rahway, NJ
Preferred:
  • Working knowledge of business process/workflow management capabilities (ex: Appian, Mendix, Pega Systems) in a regulated environment
  • Working knowledge of aggregation capabilities (data driven dashboards/visualizations)
  • Demonstrated change management knowledge and application
  • Training in process management methodology (e.g., Sigma certification)



Qualifications:
Education:
  • B.S. with 12 years of industry experience, at least 6 of those in a regulated and/or compliance area and experience with technical systems in a regulated environment.
  • Master's degree with 8 years of relevant experience, at least 6 of those in a regulated and/or compliance area and experience with technical systems in a regulated environment.


Required:
  • Experience in developing strategies to establish business process/workflow management capabilities in a regulated business environment
  • Experience in developing strategies to establish information aggregation capabilities in a regulated business environment
  • Knowledge of key processes and information managed within regulatory and pharmacovigilance functions.
  • Demonstrated ability to collaborate with senior management and information workers on the importance and need for business process/workflow management
  • Experience in understanding complex regulatory information relationships
  • Broad organizational awareness; can work across multiple levels within an organization
  • Working knowledge of business process/workflow management capabilities (ex: Appian, Mendix, Pega Systems) in a regulated environment
  • Working knowledge of aggregation capabilities (data driven dashboards/visualizations)


Preferred:
  • Project management skills
  • Excellent communication skills
  • Able to operate effectively in ambiguity
  • Strong business acumen
  • Demonstrated change management knowledge and application
  • Training in process management methodology (e.g., Sigma certification)


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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