Global Regulatory Writing Manager
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.
Global Regulatory Writing ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards.
- Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
- With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications;
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team Label Working Group)- May provide functional area input for Global Regulatory Plan and team goals
- May work with contract and freelance writers
- May participate in training and mentoring of junior medical writers
- May participate in departmental and cross-departmental initiatives, as appropriate;
- Generate document timelines, with team input;
- Keep abreast of relevant professional information and technology
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 collaborator with these qualifications.
- Doctorate degree OR
- Master's degree and 3 years of directly related experience OR
- Bachelor's degree and 5 years of directly related experience OR
- Associate's degree and 10 years of directly related experience OR
- High school diploma/GED and 12 years of directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area
- 5+ years experience in medical writing in the Biotech/Pharmaceutical industry
- Ability to analyze scientific data and interpret its significance in practical applications, with limited oversight;
- Excellent written/oral communication skills and attention to detail;
- Proficiency with word processing and other Microsoft Office Programs
- Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;
- Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
- Ability to understand and follow complex standard operating procedures (SOPs), guidance documents, and work instructions;
- Proficient time and project management skills.
- Self-starter with a drive and perseverance to achieve results
- Understanding and application of principles, concepts, theories and standards of scientific/technical field.
- In-depth knowledge of document management systems.
- Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidances and requirements.
Some of the vast rewards of working here
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.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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.
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.