Material Compliance Associate

Career Category

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. 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.

Material Compliance Associate

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible to assist the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review/approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process.

Responsibilities

• Quality check submissions for review to ensure alignment with internal standards

• Work with agencies and internal staff, including training on next steps and advising on process standards

• Provide administrative support during review meetings including gathering “live” edits on submission documents

• Assist with Label updates

• Periodically assist on a variety of MAC related projects

• Run Veeva reports and communicate outputs to cross functional partners

• Proofreading commercial and training materials produced by the Marketing teams

• Revise documents electronically

Other Skills

• Actively listen to and capture comments from meeting stakeholders

• Anticipate edits and work proactively in suggesting solutions

• Ability to champion collaboration, work effectively on cross-functional teams, and consistently deliver on-time

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills

• Critical thinking and problem-solving skills

• Quick learner, proactive, takes initiative

• Able to distinguish an accurate balance between strategic and tactical thinking

• Strong experience with Project Management tools, methodologies, and practices

• Proven ability to manage in a highly fluid, interactive, matrix environment

• Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, Acrobat Pro), and Veeva PromoMats

• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and influence decision-making

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 an associate with these qualifications.

Basic Qualifications:

• Bachelor’s degree OR

• Associates degree and 4 years of Marketing Communications Project Management / Copy-Editing experience OR

• High school diploma / GED and 6 years of Marketing Communications Project Management / Copy-Editing experience

Preferred Qualifications:

• Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field or other regulated industries

• 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 benef