Global Submission Management, Senior Associate
2 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.
Global Submission Management, Senior Associate
Global Regulatory Operations ensures the smooth compliant flow of information between all functional areas, internal and external to GRAAS (Global Regulatory Affairs and Strategy), including local offices, external partners and regulatory authorities. Bring strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions.Live
What you will do
Lets do this. Lets change the world. In this vital role you will lead the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers.Key activities:Creation and submission of regulatory dossiers according to agency requirements, eCTD Guidance & Specifications and agreed upon timelinesPreparation of submission ready components from internal contributors according to regional regulatory guidance and internal standardsContribution to submission strategy and timingContribution to the filing of ex-US regional submissionsDevelopment of global training and documentation for publishingCreation and maintenance of technical manuals, training documentation and SOPsParticipation in information system and software update projects as well as ongoing system validationsInteraction with vendor and supplier staffSupervision of contractors in the conduct of their dutiesKnowledge and Skills:Experience working in and leading teamsUnderstanding of the industry and business principles for a regulatory operations departmentAdvanced knowledge of the regulations and regulatory guidance applicable to global Clinical Trial and Marketing ApplicationsAdvanced knowledge of the submission and maintenance of global Clinical Trial and Marketing ApplicationsAdvanced knowledge of eCTD, eCTD Specifications and eCTD softwareAdvanced knowledge of MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishingWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications. Basic Qualifications: Masters degree Or Bachelors degree and 2 years of directly related experience Or Associates degree and 6 years of directly related experience Or High school diploma / GED and 8 years of directly related experience Preferred Qualifications:Industry experienceExperience in a regulatory operations-focused roleAdvanced experience publishing eCTD submissionsAdvanced experience with standard software used by regulatory publishing groupsThriveWhat 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. 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. Application deadline Amgen 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.
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Global Submission Management, Senior Associate
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