Associate Director, Compliance- US

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       

Broad Overview

We are looking for an experienced Compliance professional to bring expertise and partnership to all SERB compliance matters in the US. The incumbent will play a key role in developing and managing SERB’s US compliance program and serve as the main point of contact for the Commercial and Medical Affairs organizations, as well as contribute to other aspects of compliance program development and management. The individual must have experience counselling on compliance issues within a commercial organization and developing policies, procedures, and training to support the company’s robust compliance program. Other support may include providing updates on changes to laws, regulations and industry codes relating to healthcare compliance; internal investigations; auditing and monitoring activities; and support for compliance operations. In addition, the Associate Director / Director, Compliance will manage Aggregate Spend Reporting and State transparency and Rep Licensing requirements, in collaboration with internal and external support teams.

This position will report to the VP, US Legal & Compliance

As the Associate Director / Director, Compliance, some of your responsibilities will include:

• Providing strategic direction for Company’s compliance program to ensure regulatory adherence and support for business objectives.
• Further developing, maintaining, and supporting all Company compliance and ethics policies, procedures, and programs in collaboration with global compliance team.
• Developing and implementing a robust U.S. compliance training program consistent with SERB’s global compliance initiatives.
• Developing and managing the compliance auditing and monitoring plan; updating on an annual basis based on risk.
• Managing the federal and state transparency (Aggregate Spend), field representative registration, and compliance program reporting requirements, working with internal and external support teams.
• Participating in internal and external investigations and interactions with government agencies, law firms, trade organizations and other external agencies, as needed.
• Providing advice and counselling on various issues, including but not limited to labelling, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, patient support programs, customer interactions, healthcare professional (HCP) engagements, and commercial sponsorships.

• Conduct internal monitoring and auditing to ensure a high level of compliance and training; In addition, serve as SERB’s auditing agent to entities who we may engage on our behalf and interact with their compliance officers, as necessary, assuring that SERB’s standards are adhered to.

• Proactively identifying compliance risks, opportunities and mitigating actions, and collaborating across business functions to implement.

• Staying informed of new laws, regulations, and industry trends affecting the company, and assisting with development of policies and training as needed.

• Promoting the highest ethical and professional standards 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.

To be successful in this role, you should demonstrate:

• Minimum 5 years of pharmaceutical industry experience in a compliance role.
• Strong knowledge of relevant laws and regulations and compliance program framework. 
• Ability to articulate compliance problems and solutions whilst taking a firm stand where necessary.
• Juris Doctor (JD) degree and active bar membership in the relevant jurisdiction preferred.
• Pharma product launch experience a plus
• 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 at, and work with, all levels of organization. 
• Excellent presentation/platform skills. 
• Knowledge of how to craft business documents including policies, procedures, responses to inquiries, 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. 

Company Benefits:

• Vacation, Sick and Personal Time
• Medical, Dental, Vision and other Voluntary benefits
• Paid Parental Leave
• Tuition Assistance
• Discretionary Bonus Plan
• Competitive 401(k)

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.