Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel relies on the integrity, knowledge, imagination, skill, diversity, and teamwork of a person like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to partner with talented and dedicated colleagues while developing and expanding your career.

Functions include and are not limited to conducting external supplier qualifications and audits to verify clinical trial service suppliers meet our Company's Research Labs expectations and regulatory requirements. Assignments require a thorough comprehension of Good Clinical Practices regulations, technologies, and processes to identify and remediate risks prior to study implementation. The ability to rapidly assess a supplier's policies/procedures during qualifications and audits is required; both on-site and virtual reviews are expected in conduct of the qualifications and audits. Recommendations are made to internal key stakeholders and suppliers to minimize and mitigate both operational and regulatory risks.

Primary activities include and are not limited to:

• Under the direction of the Supplier Qualification Director, perform qualifications and audits of new clinical trial service suppliers to verify the supplier's qualification status prior to contract/study implementation. Oversee and facilitate the implementation of corrective actions to achieve qualified supplier status to meet our Company standards and regulatory requirements.

• Provide subject matter expertise in the application of GCPs to suppliers providing clinical trials services.

• Supplier types may include and are not limited to Contract Research Organizations, Interactive Response Technologies, electronic clinical outcome assessments, imaging and other diagnostic based technologies, patient recruitment, digital health technologies, and virtual primary investigator networks.

• Answers worldwide supplier qualification support requests in establishing services in scope of the supplier qualification process, documenting decisions and exceptions to the process, provides active engagement during the reporting process, and other administrative tasks.

• Engage in continuous process improvement activities as the supplier qualification program evolves based on stakeholder feedback and changing needs of emerging services and technologies.

• Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations, safety guidelines and company policies and procedures.

• Collaborates effectively with key stakeholders across our Company's Research Labs functional areas to help facilitate achievement of quality goals and comprehension/application of applicable regulations.

• Assist with educational and training materials and sessions to further develop competencies across worldwide our Company's Research Labs functional areas as part of ongoing training on the supplier qualification program.

Education:

• B.A./B.S. degree which may include the sciences, engineering, technology, or other relevant areas.

Required:

• Minimum of 8 years pharmaceutical or related industry experience, including work in various areas of clinical trial functions

• Strong knowledge and experience with Good Clinical Practices (GCPs).

• Demonstrated interactive, communication, negotiation, influencing, and problem-solving capabilities.

• Ability to function freely in a matrix model and in a team environment.

• Ability to travel up to approximately 20%.

Preferred Experience and Skills:

• Exposure to quality assurance practices.

• Exposure to data management, including process flow and data transfer.

• Exposure to digital health technologies, virtual primary investigators networks and / or other decentralized trial suppliers and technologies.

• Experience in aspects of the clinical trial development process.

• Exposure to clinical based system technologies.

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., 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. #EBRG #VETJOBS

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, 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:

$130,960.00 - $206,200.00

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:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):