Material Compliance Manager

Amgen Inc.; United States; Remote; USD 106,000 - 143,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Paid time off

Job summary

Amgen is seeking a Materials Compliance Manager to oversee MAC review and approval to ensure compliant messaging to the public. You will report to the MAC leadership in Regulatory Affairs and coordinate with sponsors, reviewers, and external partners.

You will drive MAC process improvements, manage stakeholder expectations, and ensure adherence to MAC policies and regulatory requirements across assigned business units.

Qualifications

• Doctorate degree required and relevant field.
• Experience in regulatory affairs or material compliance in biopharma.
• Experience with MAC process and cross-functional teams.
• Strong communication and project management skills.
• Ability to manage multiple stakeholders and priorities.

Responsibilities

• Leads MAC process improvement efforts.
• Guides MAC cross-functional team members.
• Addresses issues and provides solutions for special reviews during launches.
• Translates business priorities into MAC strategies to support objectives.
• Enforces MAC rules with Reviewers and Sponsors (project owners).
• Builds relationships with Sponsors, Reviewers, agencies and partners.
• Facilitates MAC related meetings and updates.
• Resolves stakeholder concerns and escalates when needed.
• Trains stakeholders on the MAC process.

Skills

Negotiation

Persuasion

Collaboration

Analytical judgment

Interpersonal communication

Management interface

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Career Category

Regulatory

Job Description

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Material Compliance Manager

What you will do

Let’s do this. Let’s change the world. Materials Compliance Manager who will be responsible for Material Approval and Compliance (MAC) that manages the review and approval process to ensure that only compliant messages are communicated to the public. This role will report to the Director or Executive Director of Material Compliance in Regulatory Affairs.

The Materials Compliance Manager 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.

Key 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 Enforces 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

• Reports to management on process compliance

• Trains and guides all incoming stakeholders through the MAC process

What we expect of you

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

Basic Qualifications

• Doctorate degree
• undefined
• Master’s degree and 2 years of process, compliance, and/or project management experience
• undefined
• Bachelor’s degree and 4 years of process, compliance, and/or project management experience
• undefined
• Associate’s degree and 8 years of process, compliance and/or project management experience
• undefined
• 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

External/Internal postings:

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.

Internal only posting (or Pre-ID candidate):

Amgen anticipates accepting applications until 1 week after the posting; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

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 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

105,697.50USD -143,002.50USD