Material Compliance Manager

them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Material Compliance Manager

What you will do

Let's do this. Let's change the world. In this vital role you will manage the materials review process for assigned business units and/or products. The manager will represent material compliance in process discussions with sponsors and reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The manager contributes to Amgen's compliance initiatives by ensuring that all required promotional materials have undergone MAC review.

Responsibilities

• Leads new and ongoing MAC process improvement efforts

• Provides guidance and direction to MAC Cross Functional team members

• Anticipates process issues and provides solutions for special circumstance reviews due to product launches and regulatory actions (i.e. label changes, fair balance statement, etc.)

• Has a thorough understanding of the BU/product business priorities and translates that information to material approval strategies in support of business objectives

• Ensure MAC business rules with Reviewers and Sponsors (project owners)

• Works closely with assigned Material Compliance Associates (MCA) on MAC business and compliance operations

• Builds & maintains strong relationships with project Sponsors (owners), Reviewers, agencies, third party partners, and Business Unit Compliance Lead

• Drives compliance with Amgen review guidelines, MAC Policy, as well as external regulations

• Facilitates MAC related meetings

• Addresses stakeholder concerns and facilitates a final decision on their resolution

• Uses discretion on which issues to elevate to upper management

• Manages elevation issues to resolution with senior and executive management

• Provides guidance on the use of Amgen's MAC electronic approval system

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a manager with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master's degree and 2 years of process, compliance, and/or project management experience OR

• Bachelor's degree and 4 years of process, compliance, and/or project management experience OR

• Associate's degree and 8 years of process, compliance, and/or project management experience OR

• High school diploma / GED and 10 years of process, compliance, and/or project management experience

Preferred Qualifications:

• Experience in an environment which requires extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment

• Ability to interface and communicate with all levels of management

• The skill to be assertive yet extremely tactful

• Ability to communicate and influence all levels of leadership/executive leadership

• Ability to simultaneously manage & prioritize multiple projects

• Supervision of staff

• Strong understanding of process development & process improvement

• Strong project planning, client management and analytical skills

• Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences

• Being a decisive thinker; able to evaluate and interpret complex situations

• A solid track record of strong problem-solving skills

What you can expect from us

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, 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.com

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.

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.

Sponsorship

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Salary Range
102,506.00 USD - 130,639.00 USD