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Associate Director, Compliance and Process Management

Merck Cherokee

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Rahway, NJ
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Job Description

As posted by the hiring company

Job Overview:

Job Description

This position can be remote

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The purpose of the Global Labeling (GL) Compliance & Process Management group is to maintain oversight of global labeling processes in development of compliant labeling documents which ensure the safe and effective use of products for patients and healthcare providers. The Compliance & Process Management group is accountable for ensuring well organized, high quality and efficient labeling processes are in place which allows consistent application across our Company's portfolio and therapeutic areas. As part of Global Labeling organization, and under the supervision of the Director of Compliance & Process Management, the Associate Director of Compliance & Process Management is accountable to:

Primary Responsibilities:

  • Independently supports end-to-end Global Labeling Compliance & Process Management and engage with key stakeholders to maintain control over all aspects of the Global Labeling processes, including the review and improvement of compliance metrics, key performance indicator (KPIs) and other oversight activities for the end-to-end Global Labeling processes.

  • Leverages data analytics and reporting to help analyze business performance, provide insights, and drive recommendations to improve performance.

  • Leads, contributes and project manages complex initiatives/projects within Global Labeling, requiring partnership and cross-functional collaboration across the organization. Helps create a culture of continuous improvement and looks to share and grow from internal and external best practices.

  • Support Global Labeling with inspection and audit-preparedness planning.

  • Partners with other Global Labeling colleagues and relevant stakeholders to ensure Global Labeling oversight is appropriate and maintained, and that staff involved in labeling activities comply with current processes.

  • Reviews and assessed changes to global, United States (US) & European Union (EU) regulatory requirements and industry best practices for impact to current Labeling processes, systems and tools.

  • Demonstrates advanced knowledge of regulations and regulatory trends.

  • Understands broad concepts within regulatory affairs and implications across the organization.

  • Understands and interprets process and system issues as it relates to regulatory requirements and labeling strategy.

  • Effectively applies skills to drive or participate in change efforts to enhance processes within Global Regulatory Affairs and Clinical Safety (GRACS) or across areas within our Research & Development Division that improve quality and /or add value to the business.

  • Effectively applies skills to utilize knowledge, networks and data to support rapid decision making with support of Global Labeling.

  • Skilled at working with senior leaders/leadership teams on strategy and process alignment.

Education Minimum Requirements:

  • Bachelor’s degree in a scientific or medically-related discipline required.

Required Experience and Skills:

  • Minimum of 7 years of Quality Assurance and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing strategic responsibility.

  • Experience with data analytics and reporting to help analyze business performance, provide insights, and drive recommendations to improve performance.

  • Current working knowledge of product labeling inclusive of requirements for marketed and developmental products.

  • Ability to think about data landscape holistically, combining architectures across different data domains.

  • Experience leading teams, driving consensus and results and effectively bringing teams together for common objectives.

  • Strong critical thinking, troubleshooting and problem-solving skills.

  • Excellent leadership, communication, interpersonal and collaboration skills.

  • Detail oriented, well organized, high project management skills.

  • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

Preferred Experience and Skills:

  • Ability to effectively manage and bring together teams for common objectives. Ability to lead a team in support of the vision established for the end-to-end business goals.

  • Strong technical skills to analyze data and report insights.

  • Ability to story-tell with data, leveraging strong data visualization and presentations skills focused on simplifying complex data and developing audience understanding.

  • Skilled in negotiation skills. Works well with others, especially on a cross-functional team.

  • Takes stand on important issues in a productive, respectful way.

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.

GRACSJOBS

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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 Poster

EEOC GINA Supplement​

OFCCP EEO 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.

Residents of Colorado:

Click here to request this role’s pay range.

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:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1