Material Compliance Associate

Career Category

Job Description

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. 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 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 awardwinning 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 Associate

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for assisting 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 and 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

• Supports one Material Approval and Compliance (MAC) Team.

• Supports Global Initiative/Other Project.

• Quality check submissions for review to ensure alignment with internal standards throughout the process.

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

• Collaborates with MRL to identify Reference QC issues and Match Text Harvesting

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

• Assist with Label updates.

• Periodically assist on a variety of MACrelated projects

• Run Veeva reports and communicate outputs to crossfunctional partners.

• Proofreading commercial and training materials produced by the Marketing teams.

• Revise documents electronically.

• Actively listen to and capture comments from meeting stakeholders.

• Anticipate edits and work proactively to suggest solutions.

• Ability to foster collaboration work effectively on crossfunctional teams and consistently deliver ontime.

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decisionmaking skills.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The detail oriented professional we seek is an associate with these qualifications.

Basic Qualifications:

• Bachelors degree OR

• Associates degree and 4 years of Marketing Communications Project Management / CopyEditing experience OR

• High school diploma or GED and 6 years of Marketing Communications Project Management / CopyEditing experience

Preferred Qualifications:

• 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 Healthcarerelated 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.

• CopyEditing 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 wellbeing. 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 salesbased incentive plan

• Stockbased longterm incentives

• Awardwinning timeoff plans

• Flexible work models including remote and hybrid work arrangements where possible

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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In any materials you submit you may redact or remove ageidentifying 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

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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse 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 and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range