Associate Director, Technical Product Management

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 142.000 - 224.000; Vollzeit

Zusammenfassung

Merck & Co. in Rahway, NJ, seeks a Product Manager - PV Reporting and Surveillance to lead pharmacovigilance strategy, oversee adverse event systems, and ensure regulatory compliance across global safety activities.

You will partner with Clinical, Regulatory, Safety and IT teams, manage backlog and roadmap, and drive governance, data quality, and stakeholder engagement in a fast-paced, regulated environment.

Qualifikationen

• Bachelor's degree required.
• 6+ years in data governance, compliance, privacy, risk management, or AI governance.
• Strong communication for technical and non-technical audiences.
• Experience with data governance, data products, digital solutions, and AI-enabled programs.
• Ability to develop policies, standards, SOPs, and governance processes.
• Knowledge of data management practices including data quality, metadata, security, and master data management.
• Ability to manage governance, compliance, privacy, and risk issues.
• Proven collaboration and influencing across cross-functional teams.
• Ability to drive change and adoption of governance practices.
• Strong writing, organization, and problem-solving skills.
• Ability to work in fast-paced, ambiguous environments.
• Understanding healthcare compliance laws and guidelines.
• Experience delivering training and guidance to broad audiences.

Aufgaben

• Partner with cross-functional teams to develop PV strategies that meet regulatory requirements and ensure patient safety, quality, and compliance.
• Manage and prioritize the product backlog, aligning with organizational objectives.
• Develop, maintain, and execute the Product Strategy and Roadmap.
• Oversee PV systems including software platforms for adverse event reporting and case management.
• Maintain knowledge of global PV regulations and ensure PV processes remain compliant.
• Ensure PV processes adhere to ICH guidelines.
• Maintain high-quality PV processes with data integrity and compliance.
• Collaborate with Clinical, Regulatory, Safety, and other areas to integrate PV into product development.
• Partner with Business Technology to implement PV/QC systems and enhancements.
• Build and maintain stakeholder relationships to support decision-making across functions.
• Demonstrate stakeholder management, communication, and cross-functional collaboration.

Kenntnisse

Data Quality Assurance

Management System Development

Pharmaceutical Regulatory Compliance

Pharmacovigilance

Product Management

Stakeholder Relationship Management

Strategic Planning

System Design

Veeva

Ausbildung

Bachelor's degree

Master's degree or MBA (preferred)

Jobbeschreibung

Job Description

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

The Information Technology team at our Research & Development Division is looking for Product Manager - PV Reporting and Surveillance. Reporting into the Product Line Lead for Clinical Safety. The position will take a leadership role in the development and implementation of pharmacovigilance strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.

Product managers must possess a broad base of skills and knowledge spanning digital technology, strategy and business planning, user experience design, engineering, and agile/lean development practices. They must possess an entrepreneurial drive to develop new product features while managing stakeholders' needs and timeframes to broker complex relationships that evolve into real solutions. The ultimate success of a product owner hinges on their ability to guide their peers while influencing decisionmakers.

What will you do?

• Partner with cross-functional teams to develop and implement pharmacovigilance (PV) strategies that meet regulatory requirements and ensure patient safety, quality, and compliance.
• Manage and prioritize the product backlog, ensuring business value is understood and aligned with organizational objectives.
• Develop, maintain, and execute the Product Strategy and Roadmap.
• Oversee pharmacovigilance systems, including software platforms used for adverse event reporting, case management, and signal detection.
• Maintain current knowledge of global pharmacovigilance regulations and guidelines and ensure company PV processes and systems remain compliant.
• Ensure pharmacovigilance processes and systems adhere to applicable regulatory requirements, including International Council for Harmonisation (ICH) guidelines.
• Maintain high-quality standards for PV processes and systems and implement quality control measures to ensure data accuracy, integrity, and compliance.
• Collaborate with Clinical, Regulatory, Safety, and other key functional areas to integrate pharmacovigilance processes into overall product development plans.
• Partner with Business Technology teams to manage the implementation of new PV/QC systems and enhancements, ensuring project milestones and timelines are achieved.
• Build and maintain strong stakeholder relationships to support effective decision-making, alignment, and execution across functions.
• Demonstrate strong stakeholder management skills, including communication, influence, and cross-functional collaboration.

Qualifications, Skills & Experience

Required

• Bachelor's degree
• Six or more (6) years of experience in data governance, compliance, privacy, risk management, AI governance, or related roles
• Strong communication skills with both technical and non-technical audiences
• Experience with data governance, data products, digital solutions, and Agentic AI-enabled programs
• Ability to develop policies, standards, SOPs, and governance processes
• Working knowledge of data management practices, including data quality, metadata, security/privacy, and master data management
• Ability to identify and manage governance, compliance, privacy, and risk issues
• Strong collaboration and influencing skills across cross-functional teams
• Ability to drive change, continuous improvement, and adoption of governance practices
• Strong writing, organization, and problem-solving skills
• Ability to work effectively in a fast-paced, ambiguous, and evolving environment
• Understanding of healthcare compliance laws, regulations, and guidelines
• Experience developing and delivering training and guidance to a broad audience
• Ability to build trusted relationships with internal and external stakeholders

Preferred

• Master's degree, MBA, or equivalent
• Experience supporting IT, data, analytics, or AI solutions in a complex or regulated environment
• Experience with privacy and data protection practices
• Experience supporting compliance training, reporting, and remediation activities
• Experience in healthcare or life sciences
• Experience with quality management systems
• Pharmacovigilance compliance experience

What we offer

• Exciting opportunities to work as part of a high-performing team on global projects within an international environment.
• Opportunities for continuous learning and professional growth, with the potential to develop a career across the company's global organization.

Required Skills:

Data Quality Assurance, Management System Development, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Photovoltaic Systems, Product Development, Product Management, Quality Control (QC), Safety Cases, Signal Detection Theory (SDT), Solution Architecture, Stakeholder Relationship Management, Strategic Planning, System Designs, Veeva

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only:

-We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

-We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 11/6/2026