Job Description
Career CategoryRegulatoryJob DescriptionLet’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 standardsWrite 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 narrativesWrite other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)Manage study timelines for regulatory documents and regulatory submission strategyAct as a functional area representative and lead on product teamsManage, train and mentor medical writersManage the work of GRW staffAssist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governanceEnsure quality of regulatory submission documents at all stages of developmentProvide expertise and guidance on document design and principles of good medical writing to the department and product teamsParticipate in departmental meetings, as well as departmental and cross-departmental initiatives, as appropriateWhat we expect of youWe 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 ORMaster’s degree and 8 to 10 years of Writing Regulatory or scientific submission/documents experience ORBachelor’s degree and 10 to 14 years of Writing Regulatory or scientific submission/documents experience ORDiploma and 14 to 18 years of Writing Regulatory or scientific submission/documents experiencePreferred Qualifications:BS, MS or higher degree in biology, chemistry or other scientific disciplineExperience in writing clinical and regulatory documentsAbility to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgmentAbility to analyze medical data and interpret its significanceAdvanced knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry complianceAdvanced written/oral communication skills and attention to detailUnderstanding and application of principles, concepts, theories and standards of scientific/technical fieldStrong time and project management skills, negotiating skills, and perseverance with a drive for resultsKnowledge of management skills and supervising the work of othersStrong leadership in a team environmentStrong negotiatorExperience in mentoring, training, and directing othersWhat 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.
