Let’s do this. Let’s change the world. In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards
Write or oversee 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 (eg, 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
Manage, train and mentor medical writers
Manage the work of GRW staff
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, as appropriate
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Writing Regulatory or scientific submission/documents experience OR
Master’s degree and 8 to 10 years of Writing Regulatory or scientific submission/documents experience OR
Bachelor’s degree and 10 to 14 years of Writing Regulatory or scientific submission/documents experience OR
Diploma and 14 to 18 years of Writing Regulatory or scientific submission/documents experience
Preferred Qualifications:
BS, MS or higher degree in biology, chemistry or other scientific discipline
Experience in writing clinical and regulatory documents
Ability to effectively operate in an environment that requires 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 (eg, 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
Strong negotiator
Experience in mentoring, training, and directing others
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.