Google IT Support Drafter

We are seeking a dynamic and experienced leader to join our Global Pharmacovigilance (GPV) team as an Associate Director. In this critical role, you will lead a dedicated team responsible for a wide range of pharmacovigilance activities. You will be instrumental in ensuring our operations are compliant, efficient, and consistently meet the highest standards of quality and safety. The ideal candidate will be a strategic thinker with a passion for developing people and driving process excellence., * Lead and manage Global Pharmacovigilance team members, overseeing activities such as case review and approval, aggregate report preparation, and signal management

• Establish team priorities, allocate resources effectively, and track progress to ensure all timelines and objectives are met
• Participate as needed in Global PV Leadership team meetings
• Support and participate in regulatory audits and inspections, including readiness preparation and management of Corrective and Preventive Actions (CAPAs)
• Responsible for participation in or support/oversight of one or more of the activities described below:

*

• Ensure the creation, review, and maintenance of a robust procedure management process for all Global PV documents
• Support the safety database and other PV IT applications, including participation in business-related tasks such as IT application testing
• Provide expert support to national PV teams as needed to ensure global alignment and compliance
• Monitor, interpret, and apply new and existing legislation governing pharmacovigilance to ensure ongoing compliance
• Oversee a comprehensive training program for GPV staff and other relevant personnel

Leadership Expectations:

We are looking for a leader who excels in fostering a culture of excellence and growth. The successful candidate will be expected to demonstrate core leadership skills, including:

• Mentoring & Coaching: Actively manage team questions, facilitate group meetings, and provide guidance to develop the skills and careers of your team members
• Continuous Learning: Stay current with evolving legislation and maintain a robust training program to ensure your team remains at the forefront of the field
• Proactive Problem Solving: Engage directly in resolving challenges as they arise and implement effective risk minimization strategies to prevent future issues
• Continuous Improvement & Innovation: Drive the enhancement of our processes and systems by participating in new projects and consistently seeking opportunities for innovation, AutoCAD Visionary Innovation 3D Modeling Shop Drawing Communication Rhinoceros 3D Exhibit Design SolidWorks (CAD) Technical Drawing Parametric Modeling Artificial Intelligence Technical Documentation Engineering Documentation Fusion 360 (CAD Software) Engineering Design Process +0 Aseptic Technician- 2nd Shift Actalent

Fairfield, NJ*On-Site

Coaching Operations Leadership Management Mentorship Innovation Compassion Adaptability Communication Pharmaceuticals Problem Solving Data Management Telephone Skills Pharmacovigilance Strategic Planning Process Improvement Aggregate Reporting, * PhD or DVM with 3 years experience in a highly regulated pharmaceutical field; OR

• Master’s degree with 5 years experience in a highly regulated pharmaceutical field

Desired Qualifications:

• Experience with statistical analyses
• In-depth knowledge of regulations governing pharmacovigilance for veterinary medicinal products
• Proficiency with pharmacovigilance databases and other IT applications
• Strong analytical, communication, and writing skills

Required Skills: Adaptability, Adverse Event Report, Audit Inspections, Compliance Monitoring, Data Management, Pharmacovigilance, Process Improvements, Regulatory Compliance, Regulatory Reporting, Strategic Planning, Training and Development, Asepsis Visionary Operations Innovation Punctuality Disinfecting Biotechnology Sterilization Pharmaceuticals Detail Oriented Medical Devices Computer Literacy Strong Work Ethic Aseptic Processing Sterile Processing Workflow Management Process Architecture Artificial Intelligence Engineering Design Process Standard Operating Procedure Good Manufacturing Practices

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 salary range for this role is $129,000.00 - $203,100.00

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.