HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Writing ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.
- Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)
- Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
- Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
- Lead study timelines for regulatory documents and regulatory submission strategy
- Act as a functional area representative and lead on product teams
- Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
- Ensure quality of regulatory submission documents at all stages of development
- Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
- Participate in departmental meetings, as well as departmental and cross-departmental initiatives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:
Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience
Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience
Associates degree and 10 years of Writing Regulatory or scientific submission/documents experience
High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experiencePreferred Qualifications:
- Masters or higher degree in biology, chemistry, or other scientific field
- 5+ years in writing clinical and regulatory documents
- Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
- Ability to analyze medical data and interpret its significance
- Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
- Strong written/oral communication skills and attention to detail
- Understanding and application of principles, concepts, theories, and standards of scientific/technical field
- Strong time and project management skills, engaging approach, and perseverance with a drive for results
- Leadership skills and ability to guide and influence the work of others
- Strong leadership in a collaborative team environment
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.
Amgen offers a Total Rewards Plan comprising 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 including:
- 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 sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. 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 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.