Director HRM Business Operations

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Reporting to the Director of Regulatory Affairs - Capability Area Lead this position serves as a Business System Lead or provides support to the Business System Owner for their capability area within the GRACS Innovation & Information Management organization. Leads a direct and matrixed team of employees, contractors and vendors and is directly accountable for day-to-day business system operations. Provides input and direction to operational strategy and innovation with their Capability Area Lead, as well as, participates in tactical execution of the strategy.

Education:

Bachelor’s degree with 5-7+ years of industry experience, at least 4 of those in a regulatory/ compliance area (Master’s Degree preferred)

Required Experience and Skills:

• Proven management experience with at least 2 year managing individuals.
• Ability to both lead teams and perform day-today operational work (e.g., Business System ownership)
• Good balance of innovation and tactical operational mindset and skills in a regulated environment and with GxP systems
• Deep Knowledge of Registration Management activities and strong regulatory knowledge,
• Strong experience working closely with Functional Business area users, IT partners, Sourcing Partners and Vendors
• Demonstrated collaborative skills and ability to work in cross-functional and international environments
• High level of motivation, drive, and demonstration of leadership values.
• Excellent written and verbal communication skills including ability to write clearly and concisely.
• Strong interpersonal skills.
• Driver of change and innovation.
• Ability to work seamlessly with all levels of personnel.
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
• Excellent presentation development, delivery and online meeting tool skills.
• Lead one of the Health Registration Management vertical teams within IIM to enable regulatory business process improvement and strategy realization through submission planning and requirements management capability enablement and ensure on-going operations.
• Actively drive toward a future state vision of submission planning and requirements management for the organization, working broadly across functional areas.
• Influence leaders to see new opportunities for enhanced submission planning and requirements management capabilities.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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., Kenilworth, 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.

Residents of Colorado

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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:

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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.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R137762