Director Global Regulatory Writing

e 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

Thrive

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

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

Equal Opportunity Statement

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.

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