Associate Director - Legal & Compliance

Job Description:

Bring your legal expertise, business acumen, and passion for healthcare innovation to a role where you will help shape strategic decisions, support compliance excellence, and contribute to improving and saving lives. Join us as a:

Associate Director - Legal & Compliance

About the role

The Associate Director - Legal & Compliance provides a broad range of legal and compliance services, support and counselling, from development through commercialization and lifecycle planning (human and animal health) that helps the Company grow and achieve its business goals. The advice given and services provided are strategic, timely, proactive, practical, cost-effective and meet the highest legal, ethical and professional standards. The position will report to the Executive Director Legal & Compliance of the Italian subsidiary.

Taska and responsibilities include but are not limited to

• Partnering with and supporting internal clients on a wide range of company business, including new product launches; support of clinical research; regulatory, pricing and reimbursement initiatives; and all aspects of commercialization of pharmaceutical products, including sales, marketing and distribution. This support includes providing guidance on legal and compliance issues in a broad business context and identifying business purposes and objectives; proactively applying legal and compliance expertise to address the specific business activity; and developing alternative legal solutions in order to enable the achievement of successful business outcomes.
• Drafting and participating in negotiations of a wide range of commercial contracts, including procurement agreements, distribution agreements and marketing agreements.
• Advising on market access issues, compliance and company law, privacy and regulatory matters.
• Overseeing the work of outside counsels in the preparation of complex legal documents, including letters, notices, legal opinions, contracts, court/ administrative filings, licenses, corporate documents, etc., ensuring the Company operates in compliance with applicable laws, regulations and corporate policies.
• Advising on a wide range of compliance issues and supporting implementation of compliance initiatives and controls; cooperating with internal clients on the completion of internal compliance audits and investigations to ensure that the company’s standards and Ethic Code are complied with.
• Collaborating effectively with members of the legal and compliance teams at all levels to provide timely, business-oriented advice to internal commercial clients on global legal and compliance issues and representing the legal and compliance team in cross-functional product teams and task forces. Continually developing expert understanding of Country laws, regulations and policies in several specialized legal areas, as well as in Company policies and procedures; strong working knowledge of laws, regulations and policies in at least one other specialized legal area.

Your profile

Education and Minimum Requirements:

• Law degree and a minimum of 5 years of post-qualification experience gained either in-house or at a law firm.
• Strong expertise in at least two areas of law, such as Commercial & Contract Law, Compliance, Anti-Bribery and Anti-Corruption (ABAC), Data Privacy, Administrative Law, and Litigation.
• Previous experience in the biotechnology or pharmaceutical sector is highly desirable, with exposure to areas such as commercial operations, marketing and promotional activities, regulatory affairs, clinical research, and interactions with healthcare professionals and organizations.
• Qualified lawyer with admission to the Italian Bar and a valid license to practice law in Italy.

Required Experience and Skills:

• LLM abroad is considered a plus.
• Native Italian speaker with an excellent command of English, both written and spoken, is required.
• Strong communication skills with a positive and collaborative style; able to translate complex legal and compliance matters into clear, practical advice for stakeholders across the organization.
• Excellent organizational skills in order to prioritize and manage multiple time-sensitive projects simultaneously.
• Strong interpersonal and influencing skills, including diplomacy and flexibility and the ability to interface effectively with personnel at many different levels.
• Ability to maintain high level of integrity of confidential and sensitive information and credibility within the organization.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Particularly skilled in taking initiative and in excellent judgment; demonstrated ability to learn quickly.

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.

This role is part of national collective labour agreement (CCNL) Chimico-Farmaceutico, Classif. " Quadro", CCNL level A1.

The Primary Location for this position is

The salary range for this position is

This is the lowest and highest salary we, in good faith, believe we would pay for this role at the time of this posting. It is based on the applicable NCBA, as well as an individual’s experience, skills, organizational needs, and compensation levels within their peer group. If applicable, employees may also be eligible for an annual bonus, long-term incentives, or other benefits. Our Talent Acquisition team will provide further information if needed.

Required Skills:

Preferred Skills:

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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.

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