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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Regulatory CMC Technical Writer

Responsibilities

• Act as Point of Contact for Amgen with vendor providing external CMC technical writing support.

• Oversee vendor team to finalize first draft CMC regulatory documents that conform to global requirements (FDA, EMA, ICH guidelines), Amgen and industry standards, defined regulatory strategy and Amgen guides within specified timelines in support of global filings, including clinical trial applications (including amendments and IMPD), and marketing applications.

• Support the Global CMC Regulatory Lead, collaborate with Amgen product teams, and/or site teams for specific strategies or activities that impact product registrations.

• Works cross functionally with Global CMC Regulatory Lead and PDT leads to coordinate preparation of regulatory filings and other documents used for registration purposes and post-marketing applications

• Identify and track regulatory submissions within scope and ensure these are added to Smartsheet tracker, and communicate upcoming workload to vendor for resource planning

• Provide input to management on annual budget for work performed by vendor

• Works within Amgen systems CDOCS/RIM/SharePoint

Basic Qualifications

• Doctorate degree and 2 years of experience Or

• Master’s degree and 4 years of experience Or

• Bachelor’s degree and 6 years of experience Or

• Associate’s degree and 10 years of experience OR

• High school diploma / GED and 12 years of experience

Preferred Qualifications

• Bachelor’s or Master’s Degree in biology, chemistry, or other scientific fields

• 5 or more years of experience with writing content for global regulatory submissions for all types of pharmaceutical products across Amgen’s portfolio

• Strong working knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., FDA, EMA, ICH) governing regulatory submission documents and industry compliance

• Proven document management skills, with good understanding of eCTD structure

• Strong computer skills with an expert command of Microsoft Word and ability to work with various document management systems

• Ability to work under tight timelines both independently and within a team to produce high quality documents with focus on timely delivery and attention to detail. Strong written/oral communication skills

• Ability to analyze scientific/technical data and interpret its significance, and discern areas of potential concern and communicate concerns effectively to management

• Strong time and project management skills, engaging approach, and perseverance with a drive for results

• Ability to self-organize, coordinate, and prioritize multiple tasks with competing activities across several parallel projects

• Leadership skills and ability to guide and influence the work of others. Strong leadership in a collaborative team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com