Job Description

The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions and functional areas.The role of the GPL involves developing and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS. The GPL actively engages with leadership across the GRACS organization and collaborates with internal and external functions such as our company's QA, GCD Standards, and Learning & Development. This collaboration is essential in developing and executing strategies that support the ongoing business needs of GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.

Core Responsibilities may include and are not limited to:

• Establish and maintain an engaged SME network as well as collaborative, and innovative culture in GRACS for business process management and continuous improvement.

• Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of multiple global business processes ensuring alignment of global to local procedures.

• Collaborates with various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations, and achieve business objectives on a global scale.

• Deep domain knowledge of the end-to-end process for their respective global business processes (e.g., enabling systems, upstream and downstream transfer of information and assets).

• Accountable for ensuring comprehensive and expert input into decisions/changes that affect business processes, roles and responsibilities, and role-based training associated with core business processes.

• Partner with Business System Owners on Alignment of Process & Technology.

• Develop &/or and manage process related artifacts (process maps, documentation, training content and role identification), ensuring alignment across impacted functional areas.

• Drive accountability for processes execution throughout GRACS through change management.

• Develop, implement and report process objectives and key performance indicators for assigned global process domains; Manage and report process performance against metric targets.

• Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.

• Lead large-scale change initiatives across GRACS and engage across GRACS leadership to identify GRACS-level projects for continuous improvement of the organization, including managing the impact of final external regulatory policies that support work that is executed in GRACS.

• Ensure organizational compliance with global regulations including integration of Final Policy requirements into core business processes and procedures.

• Conduct process assessments, manage pre-requests, and participate in audits and inspections related to GRACS processes.

• Develop and improve upon business process management organization capabilities (e.g., lean six sigma, change management, executive-level facilitation, project management, negotiations, etc.).

• Ensure alignment with cross-functionally outside of GRACS and throughout the our company to develop and improve enterprise-wide process optimization.

• Represent our company, GRACS, BCST, Process Management, Metrics and/or Knowledge Management profession in forums outside the department, including participation on M&A or Business Development Execution, as well as engagements outside the company

Education:

• Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated environment.

• Master's Degree and a minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with technical systems in a regulated environment.

Required Skills:

• Demonstrated success in both group-based and executive level facilitation

• Demonstrated success in leading strong, high performing teams

• Demonstrated success in change initiatives across a wide range of project sizes and endpoints including executive-level change initiatives.

• Advanced Training in Process Management Methodology (e.g., Sigma Greenbelt or higher)

• Broad organizational awareness; can work across multiple levels within an organization

• Demonstrated Change Management Knowledge and Application

• Project Management Skills

• Personnel Management/Coaching/Mentoring

• Excellent Communication Skills

Preferred:

• Advanced degree preferred (engineering or scientific discipline, MBA)

• Knowledge of GRACS organization, roles, and responsibilities.

• Demonstrated knowledge and success in portfolio management

• PMP Project Management Professional (PMP) or Certified Project Management (CPM)

• Six Sigma Master Blackbelt certification, or equivalent

• Change Management or Strategy Realization Framework Certification

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:10/01/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R305899