Merck & Co Hiring for Director, GRACS Business Continuity, Standards & Training (Final Policy Lead) job in Rahway Full Time

Job Description

Our Global Regulatory Affairs & Clinical Safety (GRACS) organization bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Director, Business Continuity, Training & Standards (BCST), Policy Lead, is accountable for the development and maintenance of efficient, effective, and compliant business standards and processes for the management of Final Policy Execution across GRACS.-Responsibilities include design and implementation of a fully integrated centralized model, process, structure and standards (SOPs, templates and tools) for execution and integration of Final Policy requirements in core business processes. Routine active engagement with leadership across the GRACS organization, as well as collaboration with other internal and external functions (e.g., our Research & Development Division QA, GCD Standards) is required to develop and execute strategies to support ongoing business needs. This role is a key contributor to the BCST Leadership Team, and reports to the Sr. Director, BCST.

Core Responsibilities include and are not limited to:

• Establish and maintain an engaged, collaborative, and innovative culture in GRACS for Final Policy business process management and continuous improvement.-
• Lead GRACS Final Policy SME Network and Cross-Functional Forum, establishing standards and common practices for effective business process management.
• Monitor Metrics & Health of-Final Policy Management System (i.e., Process, People, Technology).
• M anage/Facilitate escalation of requests for resources to support implementation.
• Shares knowledge, expertise and best practices and identifies/implements improvements within the business.
• Lead large-scale change initiatives across GRACS and engage across GRACS leadership to identify GRACS-level projects for continuous improvement of the organization.-
• Ensure organizational compliance with global regulations.- Participate in audits and inspections related to GRACS processes.
• Ensure alignment with cross-functionally outside of GRACS and throughout the enterprise (e.g., MRL, MMD, and GHH) to develop and improve enterprise-wide process optimization.
• Can represent our Company, GRACS, BCST, Process Management and the Metrics profession in forums outside the department and outside the company

Education:

• Bachelor’s degree with 12+ years of industry experience, at least 6 of those in a 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 at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment

Required Skills:

• Must have proven track record to be able to think critically, strategically, independently and problem solve
• Broad organizational awareness; can work across multiple levels within an organization
• Ability to lead by influence and work-effectively in matrix organizational structures
• Demonstrated success in leading strong, high performing teams
• Extensive experience with leading successful delivery of projects (pipeline, business improvement, and/or change management projects
• -Training in Process Management Methodology (e.g., Six Sigma Blackbelt or higher)
• Demonstrated Change Management Knowledge and Application,
• Program / Project Management Skills
• Excellent Communication Skills

Preferred:

• Advanced degree preferred (engineering or scientific discipline, MBA)
• Knowledge of GRACS organization, roles and responsibilities.
• PMP Project Management Professional (PMP) or Certified Project Management (CPM)
• Six Sigma certification, or equivalent
• Change Management Certification

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement-

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$159,200.00 – $250,700.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. – For Washington State Jobs, a summary of benefits is listed here .

Learn more about your rights, including under California, Colorado and other US State Acts

Search Firm Representatives Please Read Carefully-
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.-

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Remote Work

Shift:
1st – Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R237084