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Regulatory Writing Manager
4 months ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Writing ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.
Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)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, PIPs, white papers, breakthrough therapy applications, orphan drug applications)Lead study timelines for regulatory documents and regulatory submission strategyAct as a functional area representative and lead on product teamsAssist 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 mentorship 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 initiativesWinWhat 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 leader with these qualifications. Basic Qualifications: Doctorate degreeOr Masters degree and 3 years of Writing Regulatory or scientific submission/documents experienceOr Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experienceOr Associates degree and 10 years of Writing Regulatory or scientific submission/documents experienceOr High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience Preferred Qualifications:Masters or higher degree in biology, chemistry, or other scientific field5+ years in writing clinical and regulatory documentsAbility to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgmentAbility to analyze medical data and interpret its significanceSophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry complianceStrong 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, engaging approach, and perseverance with a drive for resultsLeadership skills and ability to guide and influence the work of othersStrong leadership in a collaborative team environmentThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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 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 accommodation.