Job Description

The Associate Director will be assigned a primary OpEx Hub (Continuous Process Improvement, Transformation or Quality and Compliance).
Under the direction of the Head of OpEx and Director, OpEx (Hub Lead); the Associate Director, Global Data Management & Standards (GDMS) Operational Excellence is responsible for supporting the development, implementation, oversight, and maintenance of all GDMS processes, departmental functional training, and quality/compliance management activities.

Primary activities may include, but are not limited to:

• May serve as Sub Process Owner for Essential Documents Management or other operational process areas

• May serve as primary GDMS point of contact for coordination of audits, assessments and agency inspections including preparation and presentation of material as well as participation in responses and action plans

• May provide support to oversight of performance monitoring including metrics analysis

• May support the coordination of the development and maintenance of GDMS processes and functional training programs

• Applies "Quality by Design" (QBD) principles to all GDMS processes and projects.

• Applies well established process management approaches and techniques (LEAN, Sigma, Kaizen, etc.) to develop and/or improve GDMS business processes.

• Ability to lead and influence global teams to ensure proper management of activities and processes

• Supports adherence to use of robust communication channels to drive alignment within GDMS

• Providing functional and cross-functional project management

• Supporting complex risk management

• Participation in cross functional networks including but not limited to; GDMS Quality team, GDMS Inspection Team, GDMS Sub Process Owners Network, GDMS Training Stewards, GDMS PMO Consultants, eTMF Stewards Network or other GDMS chartered groups

• Lead and/or participate in strategic improvement initiatives with application of project management principles including risk identification and management.

• Operate well individually in the face of ambiguity and translates this leadership to individual contributors to contribute to efficient forward progress as a department.

• Work with others to ensure that best practices are being employed across projects and identify opportunities for continuous improvement.

• Additional responsibilities as delegated by the Head of Operational Excellence

Education:

• At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, Health Care, Computer Science or Engineering related discipline.

Experience:

• Minimum eight years’ experience in data management, clinical research or similar discipline

Knowledge and Skills:

• Proficient understanding of Drug Discovery Process, International Council for

• Harmonization Good Clinical Practice (ICH-GCP) guidelines and how they apply to Data Management

• Proficient overall working knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval), our Company products, and worldwide regulatory data management and reporting requirements.

• Ability to work and lead cross functionally and as part of a team

• Be able to work under pressure in a changing environment with flexibility

• Ability to work independently and accept and act with appropriate accountability with minimal guidance by management

• Ability to coordinate the work of others and drive decision making

• Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas

• Exceptional demonstrated organizational, problem-solving and negotiating skills

• Demonstrated excellent project management and leadership skills (LEAN, Sigma, Kaizen, etc.)

#ONEGDMS

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

Residents of Colorado

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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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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:

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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R239857