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　　Associate Director, Compliance- US

　　Job Requisition ID:    32094

　　Department:    LEGAL

　　Category:    Corporate - Legal

　　Location:Philadelphia

　　Date:    9 Nov 2023

　　Come and Save Lives with Us! The Company 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 400 employees in 16 countries. 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 priorityWe act with integrity and accountabilityWe work together as one teamWe look for better ways forwardBroad OverviewWe 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 legal 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, Compliance will be the legal/compliance liaison for Aggregate Spend Reporting and State Licensing, working with internal and external support teams.This position will report to the VP, Legal & Compliance.As the Associate Director, Compliance, some of your responsibilities will include:Further developing, maintaining, and supporting all Company compliance and ethics policies, procedures, and programs.Developing and implementing a compliance training program.Managing the compliance auditing and monitoring plan; updating on an annual basis based on risk.Counselling on promotional and medical affairs materials and activities and ensuring that all materials are developed in accordance with Company standards and all applicable laws and regulations for pharmaceuticals.Providing timely review of all materials submitted for Medical/Regulatory/Legal (MLR) Review.Participating in internal and external investigations and interactions with government agencies, law firms, trade organizations and other external agencies, as needed.Participating in the review of planned publications, presentations, announcements, and legal agreements as appropriate to provide feedback regarding potential compliance concerns.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 compliancy 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.Acting as liaison for Aggregate Spend Reporting and State Licensin , working with internal and external support teams.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.

　　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.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 plusOutstanding 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, 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.

　　Company Benefits:Vacation, Sick and Personal TimeMedical, Dental, Vision and other Voluntary benefitsPaid Parental LeaveTuition AssistanceDiscretionary Bonus PlanCompetitive 401(k)

　　Serb Pharmaceuticalsis 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.

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　　Boston Scientific is an Equal Opportunity Employer -- Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran