Regulatory Writing Senior Manager
2 months ago
HOW MIGHT YOU DEFY IMAGINATION?
If 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 ManagerLive
What you will do
Lets do this. Lets change the world. In this vital 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 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 degree 2 years of directly related experienceOr Masters degree and 6 years of directly related experienceOr Bachelors degree and 8 years of directly related experienceOr Associates degree and 10 years of directly related experienceOr High school diploma / GED and 12 years of directly related experience Preferred Qualifications:Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferredExperience with regulatory documents in Regulatory Affairs, Research, Development or related area5+years of experience in medical writing in the Biotech/Pharmaceutical industryThriveWhat 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. 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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