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Counsel

Job DescriptionWe partner with the business to ensure we maintain our company's values and high ethical standards, comply with the law, protect our people and enhance our reputation. We strive to foster an environment that is inspiring, supportive and diverse.The position provides legal support to the Human Health Division, with a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines, commercial contracting and fraud and abuse risks. The position also provides legal support to the Research Division and Compliance department on various matters. The role provides legal counseling services that are consistent with law and company policies, furthering business objectives while appropriately balancing legal requirements and risks. Specific areas of responsibility include, but are not limited to:• Food, Drug, and Cosmetics Act compliance• Fraud and abuse and antitrust compliance• Advertising and promotion and compliance• Pricing, access and reimbursement policies and practices• Commercial contracting• Product labeling• Clinical research activities• Commercial and Medical Affairs policies and practices• Policy initiatives in support of business and research activities• Related liability and regulatory issues• Policy initiatives in support of business activitiesPosition Qualifications:Education Minimum Requirement:• Graduate of an accredited US law school; admission to the Bar of Pennsylvania or another state.Required Experience and Skills:• At least 4 years of legal experience in a law firm or corporate setting, some of which must have been working in at least one of the following:• (1) the FDA,• (2) the pharmaceutical area OR• (3) product liability litigation.Preferred Experience and Skills:• Experience in product liability litigation or enforcement litigation and business counseling is a plus.• The candidate must have excellent teamwork, communication and analytical skills and an aptitude for managing a portfolio of issues.• Knowledge of the laws applicable to the pharmaceutical industry is preferred• Experience in managing a significant workload, with the ability to juggle multiple projects simultaneously• Ability to be proactive, take initiative, and manage a portfolio of issuesNOTICEFORINTERNALAPPLICANTSIn 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 separationpackage, 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.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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 Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe 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.U.S. Hybrid Work ModelEffective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.Learn more about your rights, including under California, Colorado and other US State ActsSearch Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):N/ARequisition ID:R249802
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Average salary estimate

$135000 / YEARLY (est.)
min
max
$120000K
$150000K

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What You Should Know About Counsel, Merck

Are you a skilled legal professional looking to make a significant impact in the healthcare industry? Join Merck & Co., Inc. as Counsel, based in North Wales, PA, where you will be integral to ensuring that our company's values and ethical standards are upheld. In this role, you’ll provide comprehensive legal support to our Human Health Division, tackling exciting challenges related to FDA promotion and labeling of drugs and vaccines, along with commercial contracting and addressing fraud and abuse risks. Your expertise will not only support top-tier compliance but will also enhance our company’s reputation. Each day will be filled with engaging projects ranging from Food, Drug, and Cosmetics Act compliance to advertising and promotion compliance, with an emphasis on maintaining a strong connection between legal requirements and business objectives. You'll assist in clinical research activities and navigate regulatory issues while working closely with the Research Division and Compliance department. We look for candidates who have a strong legal background, including at least 4 years in a law firm or corporate setting, with a focus on healthcare. If you thrive in a team-oriented, dynamic environment and possess excellent communication and analytical skills, this role is perfect for you. With flexibility in our hybrid work model, you’ll enjoy balancing remote work with collaborative days in the office. Come be a part of an inspiring and diverse environment where your contributions truly matter!

Frequently Asked Questions (FAQs) for Counsel Role at Merck
What are the main responsibilities of a Counsel at Merck & Co., Inc.?

As a Counsel at Merck & Co., Inc., your main responsibilities include providing legal guidance related to FDA promotion and labeling of drugs and vaccines, ensuring compliance with various laws, and supporting commercial contracting. You will engage in critical areas such as food and drug compliance, fraud and abuse regulations, and contribute to clinical research and policy initiatives.

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What are the qualifications needed for a Counsel position at Merck & Co., Inc.?

To qualify for the Counsel position at Merck & Co., Inc., candidates must hold a degree from an accredited US law school and be admitted to the Bar of Pennsylvania or another state. Additionally, a minimum of 4 years of legal experience in either a law firm or corporate setting is essential, with experience in the FDA, pharmaceutical law, or product liability being highly encouraged.

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What skills are essential for the Counsel role at Merck & Co., Inc.?

Successful candidates for the Counsel role at Merck & Co., Inc. should showcase excellent teamwork, communication, and analytical skills. Proficiency in managing multiple projects simultaneously and possessing a strong understanding of laws applicable to the pharmaceutical industry are critical in this fast-paced environment.

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Is the Counsel position at Merck & Co., Inc. a hybrid role?

Yes, the Counsel position at Merck & Co., Inc. operates under a hybrid work model. Employees are expected to work onsite three days a week, including designated office days, and can work remotely on Fridays unless business needs dictate otherwise.

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What does the recruitment process for a Counsel at Merck & Co., Inc. involve?

The recruitment process for a Counsel position at Merck & Co., Inc. typically involves submitting an application, followed by interviews that assess both your legal expertise and cultural fit within the company's diverse and inclusive environment. Prepare to discuss your experiences and approach to legal challenges.

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Common Interview Questions for Counsel
What experience do you have with FDA promotion and labeling?

In answering this question, detail your past experiences that involved compliance with FDA regulations. Provide specific examples of projects or tasks where you successfully navigated labeling guidelines or promotional compliance.

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How do you ensure that your legal advice balances risk and business needs?

Discuss your strategic approach to legal counsel, emphasizing your ability to analyze risks versus business objectives. Highlight any frameworks or methodologies you use to make informed decisions that support business growth while adhering to legal standards.

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Can you describe a challenging legal issue you handled and its outcome?

Share a specific situation where you faced a significant legal challenge. Describe how you analyzed the issue, the actions you took, and the eventual outcome. This demonstrates your problem-solving skills and resilience.

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What is your approach to compliance in the pharmaceutical industry?

Explain your understanding of compliance frameworks in the pharmaceutical sector, including the importance of adhering to laws and regulations. Discuss how you have implemented compliance protocols in past roles.

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How do you stay updated on changes in healthcare laws and regulations?

Mention the various resources you utilize, such as industry publications, professional organizations, and networking, to stay informed about evolving legal standards, especially in healthcare and pharmaceuticals.

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Describe your experience with commercial contracting.

Detail your involvement with commercial contracts, including drafting, negotiation, and management. Share examples that highlight your skills in ensuring contractual compliance and protecting the organization’s interests.

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How do you handle tight deadlines and multiple projects?

Describe your prioritization strategies, such as creating timelines and maintaining organization. Provide an example of a time when you managed competing deadlines successfully.

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What role does collaboration play in your legal practice?

Discuss the importance of teamwork in legal settings, especially in advisory roles like that of a Counsel. Share instances where collaboration with other departments or legal teams led to effective outcomes.

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What experience do you have in drafting and reviewing policies?

Explain your experience with policy development, providing examples where you have contributed to formulating or revising policies to ensure compliance with legal and regulatory standards.

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How would you approach a compliance issue involving fraud and abuse?

Discuss your approach to identifying compliance issues, conducting risk assessments, and implementing preventive measures. Provide examples that illustrate your proactive efforts to mitigate fraud and abuse risks in past roles.

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It all comes back to inventing for life We are all inventors here, no matter the role or title. We rise to any challenge in pursuit of better health outcomes. Everything we do, in and out of the laboratory, is based on our deep appreciation for l...

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Full-time, hybrid
DATE POSTED
December 7, 2024

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