Compliance Manager Program Effectiveness Assessment

Career Category

Job Description

Join Amgens Mission of Serving Patients

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 awardwinning 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.

Compliance Manager Program Effectiveness & Assessment

What you will do

Lets do this. Lets change the world. In this vital role you will support the global compliance program with measuring effectiveness gathering data and analyzing information to implement a strategy to measure the effectiveness of our Ethics & Compliance program.

The Manager will report to the Director of Global Program Effectiveness and Insights in Worldwide Compliance and Business Ethics (WC&BE). You will lead and support on the process and program management of designing building and maintaining Amgens Compliancerelated metrics and key performance indicators. This will involve developing standardized processes and repeatable workflows to establish the success of effectiveness across WC&BE programs working with internal and external stakeholders to compliance and identifying collecting and analyzing key data to develop and complete a strategy for assessing and evaluating each element of Amgens Ethics and Compliance program.

Responsibilities include:

• Support the development and of Compliance Program Effectiveness ensuring alignment with regulatory requirements and industry standard processes.
• Assist in the planning and of Amgens annual global risk assessment program supporting the identification evaluation and mitigation of key compliance risks.
• Identify key compliance areas define and map key requirements and analyze data to enhance program effectiveness providing insights to strengthen compliance. Focus areas include policies and procedures training communications business ethics reporting investigations and monitoring processes technology and overall program .
• Support a datadriven effective compliance program by working with stakeholders in compliance and other functions to gather data and information that underpin critical metrics and reporting under program effectiveness for the WC&BE leadership team and other relevant leadership teams.
• Assist in monitoring external industry trends and developments in the regulatory environment working across WC&BE to support how to update and adapt the programmatic build to measure effectiveness and drive continuous improvement including best practices and industry guidance.
• Stay informed on regulatory developments industry trends and emerging best practices to refine and evolve the compliance program.
• Collaborate with internal teams to optimize compliance processes enhance capabilities and integrate technology and automation to improve program efficiency.
• Work across teams and crossfunctional areas to establish and track compliance metrics generate reports and insights for leadership to measure program performance and effectiveness.

Domestic travel up to 20 for businessrelated activities may be required.

Location: While hybrid from accessible commute to Amgen Thousand Oaks CA is preferred this role may also be in a remote capacity with some expected travel.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The compliance professional we seek is an innovative leader with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 2 years of Compliance Legal Audit Monitoring Regulatory or similar experience

OR

Bachelors degree and 4 years of Compliance Legal Audit Monitoring Regulatory or similar experience

OR

Associates degree and 8 years of Compliance Legal Audit Monitoring Regulatory or similar experience

OR

High school diploma / GED and 10 years of Compliance Legal Audit Monitoring Regulatory or similar experience

Preferred Qualifications:

• 58 years of experience in pharmaceutical/biotech industry experience particularly in Compliance Legal Audit Monitoring Regulatory Affairs.
• Possess strong working knowledge of compliance program frameworks risk assessment methodologies and regulatory requirements.
• Strong interpersonal and customer engagement skills with the ability to work crossfunctionally and present findings clearly.
• Ability to analyze complex compliance data identify trends and generate meaningful insights for leadership.
• Strong collaborator and problem solver.
• High ability to research and compile trends and information from disparate sources.
• Experience working with management and partners to manage processes and provide strong business management fundamentals in daytoday work.
• Agile and able to adjust to ambiguity complexity and changing directions quickly to meet urgent business needs.
• Working 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 AntiKickback Statute (AKS) False Claims Act (FCA) current Corporate Integrity Agreements (CIAs) Accreditation Council for Continuing Medical Education (ACCME) guidelines Prescription Drug Marketing Act (PDMA) FDA commercial guidelines U.S. Federal and State data privacy laws and regulations U.S. Federal and State transparency reporting requirements similar laws and regulations in countries outside the U.S. and other relevant laws and regulations.
• Understanding of sales marketing value & access product promotion disease education device regulatory clinical research and healthcare compliance.
• Ability to initiate handle prioritize and follow through on a high volume of work.
• Past managerial experience directly managing people and/or leadership experience leading teams projects programs or directing the allocation of resources.
• High familiarity and experience with Microsoft Word Excel PowerPoint and working with document repositories.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. 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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

In any materials you submit you may redact or remove ageidentifying 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 deadline

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.

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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