Regulatory Writing Manager (Open to Remote)
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be 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 (phase 1 through 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 (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
Manage 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 guidance 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 professional we seek is a standout colleague with these qualifications.
- Doctorate degree Or
- Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience Or
- Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience Or
- Associates degree and 10 years of Writing Regulatory or scientific submission/documents experience Or
- High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
MS or higher degree in biology, chemistry or other scientific discipline
5+ years of experience in writing clinical and regulatory documents
Ability to effectively operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
Ability to analyze medical data and interpret its significance
Advanced knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., ICH) governing regulatory submission documents and industry compliance
Advanced 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, negotiating skills, and perseverance with a drive for results
Knowledge of management skills and supervising the work of others
Strong leadership in a team environment
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.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.