Compliance Manager

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: May 3, 2025

Job Description:

Join Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Compliance ManagerWhat you will doLet's do this. Let's change the world. In this vital role, you will promote and support adherence to all U.S. Healthcare Compliance requirements.Responsibilities Include:

• Assist US Compliance Leads in implementing and administering Amgen's Corporate Compliance programs & policies.
• Understand Compliance and Business strategy, and advocate for Compliance within the business.
• Provide advice, guidance, and support to staff and management on interpretation and implementation of Amgen policies & procedures.
• Maintain awareness of applicable laws and regulatory guidance that may affect Amgen's Compliance program.
• Develop training programs, materials, and workshops aligned with Amgen procedures & policies and deliver to appropriate audience.
• Gather documentation and assist with risk assessment and management activities to help identify potential areas of improvement opportunities and risk. Participate, track, and provide feedback on improvement actions.
• Analyze key performance indicators and business data to formulate and integrate compliance metrics into trend analyses and reports.
• Establish productive working relationships with business partners throughout the company and contribute to strategic decisions, manage critical processes, and develop thorough, practical solutions consistent with compliance objectives.
• Manage compliance processes relating to Amgen's interactions with Healthcare Professionals.
• Perform compliance assessments, generate contracts, and submit payment requests consistent with Amgen's Healthcare Compliance Policy and Standard Operating Procedures.
• Maintain key relationships by communicating and collaborating with business partners at various levels of leadership across different organizations including the Law department, Regulatory Promotions department, and other Worldwide Compliance and Business Ethics groups, and the International Healthcare Compliance group.
• Contribute to the completion of milestones associated with projects and activities. Interact with the business to ensure compliance processes and standards are understood and followed, and effectively communicate with third-party Healthcare Professionals.
• Identify and where appropriate escalate business issues needing resolution, as well as identifying potential process improvements and manage multiple assignments at one time.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.Basic Qualifications:Doctorate degreeOrMasters degree and 2 years of Compliance, Regulatory or Legal experienceOrBachelors degree and 4 years of Compliance, Regulatory or Legal experienceOrAssociates degree and 8 years of Compliance, Regulatory or Legal experienceOrHigh school diploma / GED and 10 years of Compliance, Regulatory or Legal experiencePreferred Qualifications:
  • 3 years of Pharmaceutical/Biotech industry experience, particularly in Compliance, Legal, Audit, Monitoring, Regulatory Affairs, or cross-functional experience in Sales, Marketing, or Medical.
  • Knowledge and understanding of Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, Pharmaceutical Research and Manufacturers of America (PhRMA) Code, U.S. Federal Anti-Kickback Statute, current Corporate Integrity Agreements (CIAs), Accreditation Council for Continuing Medical Education (ACCME) guidelines, Prescription Drug Marketing Act, FDA commercial guidelines, data privacy, and U.S. Federal and State transparency reporting requirements.
  • Ability to think strategically and to translate strategy into action plans.
  • Experience with Microsoft Excel, Word, Outlook, and PowerPoint.
  • Excellent written and verbal communication skills.
  • Ability to prioritize, be proactive, resolve conflicts, meet deadlines, follow through on assignments, and work independently and in teams.
  • Strong organizational skills, attention to detail, and on-time delivery of work product.
  • Ability to generate reports and prepare formal presentations for required forums.
  • Knowledge of the healthcare industry, recent federal and state enforcement activities, and the laws and regulations relating to the development, approval, and commercialization of biotechnology/pharmaceutical products.What you can expect from usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
    • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
    • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
    • Stock-based long-term incentives.
    • Award-winning time-off plans.
    • Flexible work models, including remote and hybrid work arrangements, where possible.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Keywords: Initial Therapeutics, Inc., Lancaster , Compliance Manager, Executive , Washington, Pennsylvania