MSD Director Global Regulatory Affairs & Clinical 

United States, New Jersey, Rahway 

65644500

Job Description

Core Responsibilitiesmayinclude and are not limited to:

• Establish and maintain an engaged SME network as well as collaborative, and innovative culture in Global Regulatory Affairs and Clinical Safety 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 Global Regulatory Affairs and Clinical Safety 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 Global Regulatory Affairs and Clinical Safety and engage across Global Regulatory Affairs and Clinical Safety leadership to identify Global Regulatory Affairs and Clinical Safety -level projects for continuous improvement of the organization, including managing the impact of final external regulatory policies that support work that is executed in Global Regulatory Affairs and Clinical Safety .

• 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 Global Regulatory Affairs and Clinical Safety 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 Global Regulatory Affairs and Clinical Safety and throughout the our company to develop and improve enterprise-wide process optimization.

• Represent our company, Global Regulatory Affairs and Clinical Safety , 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 Global Regulatory Affairs and Clinical Safety organization, roles, and responsibilities.

Current Contingent Workers apply

US and Puerto Rico Residents Only:

if you need an accommodation during the application or hiring process.

U.S. Hybrid Work Model

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, Monday - 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 acollective-bargainingagreement (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:

$169,700.00 - $267,200.00

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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