Regulatory Writing Sr Mgr at Amgen

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONIf you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Regulatory Writing Senior ManagerLiveWhat you will doLets do this. Lets change the this key role you will serve as the functional area lead on product teams lead writing activities for complex product submissions provide functional area expertise train and mentor more junior writers and lead departmental activities. Key responsibilities include:Author or oversee the authoring of all regulatory submission documents 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 and Pediatric Investigation PlansConduct the formal review and approval of authored documents following applicable standard operating proceduresWith limited supervision lead regulatory writing activities for complex product submissions including new and supplemental drug applications/biologics license applicationsServe as functional area lead on product teams (e.g. Global Regulatory Team Evidence Generation Team Global Safety Team Label Working Group)Provide functional area input for Global Regulatory Plan and team goalsSupervise the work of contract and freelance writers and mentor junior medical writers as assignedLead departmental and cross-departmental initiatives as appropriateGenerate document timelinesWinWhat we expect of youWe 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 degree and 2 years of directly related experienceORMasters degree and 6 years of directly related experienceORBachelors degree and 8 years of directly related experienceORAssociates degree and 10 years of directly related experienceOrHigh school diploma / GED and 12 years of directly related experiencePreferred Qualifications:Experience with regulatory documents in Regulatory Affairs Research Development or related area5years of experience in medical writing in the Biotech/Pharmaceutical industryThriveWhat you can expect of usAs 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 imaginationObjects in your future are closer than they appear. Join us.Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.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..Salary Range143169.00 USD - 174830.00 USDRequired Experience:Manager Key Skills Hair And Beauty,Facilities,IT Support,Bank,Asp.Net MVC Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 174830 - 174830