Job Description
Career CategoryRegulatoryJob DescriptionLet’s do this. Let’s change the world. In this vital role you will discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.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 goalsMay work with contract and freelance writersMay participate in training and mentoring of junior medical writersMay participate in departmental and cross-departmental initiatives, as appropriate.Generate document timelines, with team inputKeep abreast of relevant professional information and technologyWe 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 ORMaster’s degree and 4 to 6 years of directly related experience ORBachelor’s degree and 6 to 8 years of directly related experience ORDiploma and 10 to 12 years of directly related experiencePreferred Qualifications:Proficiency with word processing and other Microsoft Office ProgramsSignificant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds;Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions;Understanding and application of principles, concepts, theories and standards of scientific/technical field.Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance’s and requirements.Soft Skills:Excellent written/oral communication skills and attention to detailAbility to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;Proficient time and project management skills.Self-starter with a drive and perseverance to achieve resultsWhat you can expect of usAs 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.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com.
