VP Legal & Compliance (US) (32161)

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability        
• We work together as one team         
• We look for better ways forward       

As the VP of Legal & Compliance (US), you will be responsible for providing strategic legal counsel and business advice as a partner to the US business units and support teams (the "Business"). As a member of the US Business leadership team, you will provide legal advice, counsel and service to internal management concerning legal rights, obligations, and risks specific to the company, the Group and the industry.

You will keep current on legislative issues, statutes, decisions and ordinances, examine legal data to determine advisability of defending or prosecuting lawsuits, and support the global business development team in various transactions. In addition, you will actively support and shape the shorter and longer-term strategic interests and objectives of the Business and the Group. You will translate consideration of those interests and objectives as appropriate into actionable and risk intelligent business advice.

You will collaborate closely with the Group General Counsel and the Legal and Compliance team based in Europe, and  shape and oversee the required frameworks, guidelines and processes to provide strategic and trusted business partnering to the global Business. You will supervise and have oversight of the US Compliance team with the Associate Compliance Director, reporting directly to you.

This is a hybrid role, which requires onsite work a minimum of three days per week at our Conshohocken office (subject to change) and may require traveling within and outside the USA.

This position will report to the Group CFO.

As VP, some of your responsibilities will include:

• Drafting, reviewing, advising on and negotiating all manner of commercial, intra-group and operational contracts.
• Supporting the Group General Counsel in managing significant contracting matters, litigation matters, disputes, and litigation exposure in the US to protect the interests of the organization.
• Supervising the US Compliance team, ensuring compliance with applicable laws, regulations, and codes, including fraud and abuse laws, FDA laws regulating the sale and marketing of pharmaceutical products, the Sunshine Act, the Anti-Kickback Statute, and the Foreign Corrupt Practices Act and developing a corresponding training plan.
• Proactively managing legal risks and identifying legal support opportunities for the Business by staying abreast of statutory and regulatory developments and enforcement and litigation trends and providing corresponding proactive and strategic guidance to the Business leadership.
• Aiding in the design, implementation and monitoring of Compliance, Data Protection, ESG and related procedures as well as the follow-up of internal control and risk management best practices.
• Aiding in the preparation of corporate documents for general meetings, boards and committees.
• Participating in the M&A processes, with a focus on due diligence and integration.
• Participating in the Group’s Risk Committee, and contributing to risk management initiatives generally.
• Working closely with Group Procurement, notably on the Contracting Process and its related workflows.
• Working extensively with the Group’s ContractLogix contracts management platform, ensuring high quality inputs and effective utilization of the information therein (such as contract expiry dates, critical performance clauses, etc).
• Participating as a member of the US Management Committee.
• Providing legal support to the company’s aggregate spend, state licensing and VAWD certification initiatives.
• Serving as an active and commercially minded partner to the Business, including the commercial, clinical, R&D, Market Access and Medical Affairs teams.
• Providing legal support and approval of advertising, promotional, and communications campaigns and materials.
• Overseeing and approving the US Legal budget and forecasts, coordinating closely with the EMEA Legal Director.
• Engaging and managing outside counsel as needed.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

• Juris Doctor or international equivalent.
• Bar admission in at least one state and qualified to practice in-house in PA.
• 10+ years of experience with at least 5 years in the pharmaceutical industry.
• Strong knowledge of relevant laws and regulations. 
• Pharmaceutical product launch experience preferred.
• Ability to articulate legal problems and solutions whilst taking a firm stand where necessary.
• Strong experience in drafting, advising on and negotiating a broad variety of agreements.
• Outstanding interpersonal consultative and communication skills (verbal and written) - able to effectively collaborate and communicate with client groups, senior management, and executives within the company.
• Ability to gain trust and work across functions and with all levels of the organization. 
• Excellent presentation/platform skills. 
• Knowledge on crafting business documents including policies, procedures, responses to inquiries, complaints, audits, and investigations.
• Sincere desire for self-motivated continuous learning. 
• Experience in providing training to various audiences throughout the Company.
• Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities, and challenges.
• Ability to identify and creatively address problems in an organized, practical, systematic way. 

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.