Compliance Senior Manager, U.S. Rare Disease

Amgen • Chicago, IL

30d

About The Position

Join Amgen’s Mission of Serving Patients At 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 Senior Manager, U.S. Rare Disease What you will do Let’s do this! Let’s change the world! The Senior Manager, Rare Disease Compliance, will serve as one of the compliance business partners for the Amgen Rare Disease Business Unit (RDBU), serving on a team that works closely with that organization’s leadership to uphold the reputation of Amgen and drive ethical solutions for the patients it serves. As a member of Amgen’s Worldwide Compliance & Business Ethics organization, the Senior Manager, Rare Disease Compliance, will work with various cross-functional organizations including Law, Regulatory, and Privacy to appropriately advise the business on how best to maintain a strong culture of compliance, integrity, and ethics, and mitigate risk related to key strategic initiatives. Reporting to the Senior Director of Rare Disease Compliance, this individual will leverage understanding and knowledge of the U.S. regulatory, enforcement, and compliance environment within the biopharmaceutical industry, with particular experience in interpreting: FDA drug promotional requirements U.S. privacy requirements Government transparency reporting Industry standards for compliance and ethics (PhRMA Code)

Requirements

• Doctorate degree and 2 years of experience in compliance or legal supporting bio-pharmaceutical business
• Master’s degree and 4 years of experience in compliance or legal supporting bio-pharmaceutical business
• Bachelor’s degree and 6 years of experience in compliance or legal supporting bio-pharmaceutical business
• Associate’s degree and 10 years of experience in compliance or legal supporting bio-pharmaceutical business
• High school diploma / GED and 12 years of experience in compliance or legal supporting bio-pharmaceutical business

Nice To Haves

• Proven skills in developing and implementing strategies and results in a complex and dynamic organization
• Ability to prioritize work-related tasks and effectively communicate with leadership
• Strong written, spoken, and interpersonal communication skills with attention to detail; polished, poised presenter
• Ability to efficiently navigate an exciting and dynamic environment
• Strong critical thinking, problem-solving and planning skills
• Commitment to collaborating remotely with a diverse group of people and backgrounds
• Entrepreneurial spirit, passion, and creativity

Responsibilities

• Proactively support and anticipate RDBU compliance needs by embedding within assigned leadership teams and providing compliance guidance
• Assist with development of multi-dimensional strategies tailored to the unique circumstances and needs of each RDBU business that incorporate learnings from monitoring, investigations, business engagement, and industry developments
• Engage and work closely with RDBU leadership to develop and drive solutions that elevate ethical decision-making and honorably secure access for current and future patients.
• Leverage knowledge of the rare disease landscape and regulatory environment to thoughtfully and openly advise the RDBU
• Monitor industry-wide compliance and enforcement trends
• Be prepared to travel to conferences, internal training, and/or meetings to support RDBU Compliance initiatives

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees