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.
Director Global Regulatory Writing
What you will do
Let’s do this. Let’s change the world. In this vital role you will oversee the regulatory writing staff and projects within one or more therapeutic areas.
Prepare and oversee the review and approval of scientific and regulatory submission documents.
Serve as functional area lead on product teams.
Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization.
Provide expertise and guidance on document design and principles of good medical writing to individual staff, the department, product teams, and other functional areas.
Supervise, train, coach, and mentor regulatory writers.
Oversee the work of contract writers and CROs assigned to program documents.
Manage and implement day-to-day departmental activities and operations, including hiring; resourcing projects; leading or participating in cross-functional process development, training, and oversight; business process ownership; and meeting management.
Assist executive leadership with resource and budget planning and other department management activities, as needed.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Writing professional we seek is a leader with these qualifications.
Required experience includes:
Doctorate degree and 4 years of directly related experience
OR
Master’s degree and 8 years of directly related experience
OR
Bachelor’s degree and 10 years of directly related experience
The successful candidate will have the following skills:
Experience reading, understanding, and applying regulations to constantly changing environment
Proven leader in a team environment which requires motivation, negotiation, persuasion, collaboration, and analytical judgment
Expertise in analyzing scientific data and interpreting its significance in practical applications
Excellent written/oral communication skills and attention to detail
Superior time and project management skills
Self-starter demonstrating perseverance with a drive for results
Strong management and supervisory skills with previous experience developing and delegating to direct reports
Advanced knowledge of scientific writing and editing and a detailed knowledge of the clinical development process for new compounds
Advanced knowledge of related regulatory/industry considerations and guidelines, compliance issues, and/or issues affecting scientific discovery
Advanced understanding and application of principles, concepts, theories and standards of scientific/technical field
Recognized as a functional-area/subject-matter expert within defined subject area
Applies expert knowledge and broad understanding of multiple disciplines to achieve efficiencies
Understands the core business process and purpose of the functional area in Amgen's commercialization process
What you can expect of us
As we work to develop treatments that take care of others, so we 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
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
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.