At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Lets do this! Lets 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 organizations leadership to uphold the reputation of Amgen and drive ethical solutions for the patients it serves.
As a member of Amgens 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)
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
We are all different yet we all use our unique contributions to serve patients. The Compliance professional we seek will meet these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of experience in compliance or legal supporting bio-pharmaceutical business
Masters degree and 4 years of experience in compliance or legal supporting bio-pharmaceutical business
Bachelors degree and 6 years of experience in compliance or legal supporting bio-pharmaceutical business
Associates 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
Preferred Qualifications:
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
As 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 well 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
In 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.
Amgen 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.
Sponsorship for this role is not guaranteed.
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.
.Salary Range
141843.00 USD - 177165.00 USDRequired Experience:
Senior Manager
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more