Director Product Integrity

Job Description

Position Description:

Director Product Integrity

Reporting to the AVP, Global Security, the Director - Product Integrity is responsible for the development and execution of investigative and enforcement operations intended to protect Company products from illicit actions, including acts of counterfeiting, diversion, tampering, and theft.  The focus of this work is on protecting patient safety from the dangers of counterfeit and illicit medicines.

The Director will lead a global workforce of direct and matrixed personnel. The position will be the primary liaison for internal and external interactions associated with Product Integrity investigation and enforcement matters for the Company.  Further leadership and guidance to additional Global Security activities and mission support will be provided at the direction of the AVP, Global Security.

Primary work will include:

Lead the execution of the Company’s global Anti-Counterfeiting Strategy, including strategic and tactical operations designed to protect the Company’s patients from threats of counterfeit and other illicit products via effective investigations leading to meaningful enforcement outcomes, and coordinated advocacy and awareness initiatives of associated threats. The following are general areas of focus:

• Investigations

  • Oversee global investigations into alleged illicit trade activity involving Company products

  • Oversee the Company’s online monitoring program and threat assessment of illicit internet drug sellers

  • Assure all investigative activities remain compliant with Company policies including accurate and complete documentation within the internal Company Incident Management system.

  • Lead a robust Investigative Compliance program that assures all investigations comply with Company and international requirements related to anti-bribery, corruption, and other related offenses.

• Enforcement

  • Lead the Product Integrity investigative policies and procedures to assure completion and compliance with internal and external reporting requirements, including assurance that the Company complies with related regulatory and government agency reporting requirements associated with counterfeit, falsified, and illegitimate products, such as the US Drug Supply Chain Security Act and EU Falsified Medicines Directive

  • Provide strategic leadership to global enforcement strategies for confirmed Product Integrity events

  • Oversee global trademark recordation activities for Company products

  • Oversee the referral of confirmed Product Integrity cases to global Law Enforcement agencies or prosecutors for potential criminal enforcement

  • In conjunction with Legal stakeholders, develop and execute a civil enforcement program associated with enforcing against illicit trade

• Awareness/Advocacy

  • Develop and manage internal corporate policies and procedures related to Product Integrity

  • Cultivate and maintain relationships that support internal and external awareness, engagement, and advocacy for Product Integrity matters

  • Oversee, along with key internal stakeholders, Policy, Awareness and Advocacy efforts aimed at increasing awareness of Product Integrity risks

  • Provide leadership and participation in external associations focused on pharmaceutical crime, patient safety and/or IP protection matters

  • Maintain close liaison with government, industry, investigative, and law enforcement professionals as it relates to Product Integrity matters

  • Oversee internal and external illicit trade-related training activities

  • Ensure communication and oversight of key milestones and deliverables to support Company anti-counterfeit strategy

• People Management and Organizational Leadership

  • Provide effective leadership that motivates, engages, and develops a global team of Product Integrity professionals focused on investigation, enforcement, and advocacy activities associated with counterfeit and illicit medicines

  • Develop and maintain effective direct and matrixed organization and network necessary to support the Product Integrity mission

  • Act with the highest level of integrity, ethics, and collaboration

• Financial Management

  • Manage operational expenditures to align with corporate and regional business activities and requirements, ensuring proactive measures and timely security services on incidents, investigative work, training needs, and ongoing maintenance of Global Security programs while prioritizing service to the identified high security risks for the Company.

  • Provide strong financial stewardship of Product Integrity budget, assuring spend is focused on supporting the mission and does not exceed approved authorized levels.

• Develop and Maintain Subject-Matter-Expert status for issues related to counterfeit Company products

TRAVEL:

• Anticipated 20% travel, domestic and international

Position Qualifications:

Education Minimum Requirement:

• Bachelor’s Degree within a related field

Required Experience and Skills:

• Minimum 10 years’ experience in leading teams associated with the investigation and enforcement of illicit trade, to include within the US and internationally

• Understanding of Law Enforcement investigations and related enforcement actions within the US and internationally, as well as experience in generating case reports for criminal and civil enforcement

• Excellent verbal and written communication skills

• Ability to work in highly collaborative and matrixed environment

• Must be innovative and independent, able to manage an aggressive workload in a high performing environment

• Demonstrated experience interacting with senior leadership and government officials

• Committed to successfully leading and managing in a matrixed environment with exceptional level of integrity, ethics, collaboration, clarity and honesty in dealing with peers, team members and all others in a flat and nimble organization.

• Ability to champion new ideas or positions to meet key goals and initiatives

• Strong commitment to patient safety and compliance requirements

• Demonstrated strong cross-functional team leadership abilities and experience

• Experience in people management and employee development

• Sound understanding of global pharmaceutical supply chains and industry practices

• Experience in development of training programs for government agencies, including Customs, Regulators, and Law Enforcement

• Understanding of Intelligence and Risk Management methodologies

Preferred Experience and Skills:

• Professional experience associated with investigations of counterfeit and other illicit pharmaceutical products

• Professional experience with Product Integrity/Brand Protection project management; to include online monitoring, threat assessments, and associated strategy development

NOTICEFORINTERNALAPPLICANTS

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.

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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R277380