Business Process Management and Aggregation Director - Regulatory Affairs Job

Business Process Management and Aggregation Director - Regulatory Affairs-REG003071

Description

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The Business Process Management and Aggregation Lead is accountable for the delivery of a global, enterprise system that enables GRACS (Global Regulatory Affairs and Clinical Safety) 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 (Global Regulatory Affairs & Clinical Safety)

- 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 (Global Regulatory Affairs & Clinical Safety) and across the divisions (MRL, MMD, GHH) in relation to business process/workflow management and achieve alignment and efficiencies

- Drive alignment of GRACS (Global Regulatory Affairs & Clinical Safety) 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 (Global Reg. Affairs & Clinical Safety)

- 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 information management strategy

- Drive continuous improvement into our business process/workflow management capability through iterative refinements and identifying new opportunities

Qualifications

Education:

- B.S. with a minimum of 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 a minimum of 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:

- 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 Experience:

- 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)

- Demonstrated change management knowledge and application

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

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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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Job: Regulatory Affairs Generic

Job Title:Dir, Regulatory Affairs

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck