Material Compliance Manager

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October 29

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Amgen

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Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Manage the materials review process for assigned business units and/or products • Represent material compliance in process discussions with sponsors and reviewers • Ensure that all required promotional materials have undergone MAC review • Lead new and ongoing MAC process improvement efforts • Provide guidance and direction to MAC Cross Functional team members • Anticipate process issues and provide solutions for special circumstance reviews due to product launches and regulatory actions • Works closely with assigned Material Compliance Associates (MCA) on MAC business and compliance operations • Build & maintain strong relationships with project Sponsors (owners), Reviewers, agencies, third party partners, and Business Unit Compliance Lead • Drive compliance with Amgen review guidelines, MAC Policy, as well as external regulations

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of process, compliance, and/or project management experience • Bachelor’s degree and 4 years of process, compliance, and/or project management experience • 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 • 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 • 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

🏖️ Benefits

• 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 • 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