Senior Material Compliance Associate
AmgenAbout the role
Career Category
RegulatoryJob 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. 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, 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.
Senior Material Compliance Associate
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible for leading MCA Staff members and assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process.
Responsibilities
Lead 1 MAC Team:
Provide process guidance/ system pathways and issue resolution when issues arise to the MAC Team and Cross Functional Partners
Manage MAC, Office Hours, and Prioritization
Partner with Commercial Director and Brand teams
Manage elevation process
Ensure compliance along all phases of the MAC process
Serve as a neutral partner to ensure business needs are met
MCM Back-Up Coverage
Leads Global Initiative/Other Project
Plans and executes with minimal direction
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek has these qualifications.
Basic Qualifications:
Master's degree OR
Bachelor's Degree and 2 years of Marketing Communications Project Management experience OR
Associate degree and 6 years of Marketing Communications Project Management experience OR
High school diploma, or GED, and 8 years of Marketing Communications Project Management experience
Preferred Qualifications:
Experience in Leadership and/or management role.
An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field, or other regulated industries
Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats
Experience in leading the creation of marketing materials from concept to commercialization.
Experience managing the approval process of marketing materials that are produced at high volumes.
Copy-Editing experience including excellent typing and spelling skills.
Able to proofread materials using Adobe Acrobat Professional
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 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
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