Director Global Regulatory Writing

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Director Global Regulatory Writing




Live

What you will do

Lets do this. Lets 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

Masters degree and 8 years of directly related experience

OR

Bachelors 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