Material Compliance Manager

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. 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, 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. Material Compliance Manager What you will do Lets do this. Lets 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. 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 Amgens 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 Masters degree and 2 years of process, compliance, and/or project management experience undefined Bachelors degree and 4 years of process, compliance, and/or project management experience undefined Associates 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, 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 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. #J-18808-Ljbffr