Participate in and lead discussions during roundtable meetings to address comment resolution.
Collaborate with project teams to author responses to Heath Authority questions and requests (RTQs)
Prepare and manage timelines for document delivery
Organize/prioritize work with limited guidance and manage projects in a timely and effective manner
Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization
Ensure quality of regulatory submission documents at all stages of development and ensure compliance with global regulatory standards
Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
Knowledge and Skills
Demonstrated ability to lead teams
Strong oral and written communication skills and attention to detail
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
Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding of medical terminology and statistical methodology is a must.
Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as edit on all levels, from copy editing to major rewriting.
Experience and proficiency with document templates and proper version control.
Strong time and project management skills
Ability to anticipate and mitigate against future strategic issues & uncertainties
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome – influencing and negotiation skills
Planning and organizing abilities
Managing multiple activities
Problem solving abilities
Doctorate degree and 2 years of Regulatory Writing experience
Master’s degree and 6 years of Regulatory Writing experience
Bachelor’s degree and 8 years of Regulatory Writing experience
Associate’s degree and 10 years of Regulatory Writing experience
High school diploma / GED and 12 years of Regulatory Writing experience
PhD, PharmD, MS, RN, or RPh in a relevant scientific or pharmaceutical discipline
Experience with biosimilar development
8+ years experienced in writing clinical and regulatory documents
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.