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Regulatory Writing Manager (Open to Remote)

Company: Amgen
Location: New Brunswick
Posted on: November 15, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.Regulatory Writing ManagerLiveWhat you will doLets do this. Lets change the world. In this key 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 (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 narratives
  • Write other regulatory submission documents (e.g., RTQs, PIP, white papers, breakthrough therapy applications, orphan drug applications)
  • Manage study timelines for regulatory documents and regulatory submission strategy
  • Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
  • Ensure quality of regulatory submission documents at all stages of development Provide expertise and guidance on document design and principles of good medical writing to the department and product teams
  • Participate in departmental meetings, as well as departmental and cross-departmental initiativesWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications.Basic Qualifications:Doctorate degree OR Master's degree and 3 years writing Regulatory or scientific submission/documents experience OR Bachelors degree and 5 years of writing Regulatory or scientific submission/documents experience, OR Associates degree and 10 years of Writing Regulatory or scientific submission/documents experience, OR High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experiencePreferred Qualifications:
    • MS or higher degree in Biology, Chemistry or other scientific field
    • 5+ years of demonstrated professional experience in writing clinical and regulatory documents Ability to operate optimally in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
    • Capability to analyze medical data and interpret its significance
    • Extensive knowledge of scientific/technical writing and editing and of related regulatory guidance (e.g., ICH) governing regulatory submissions and industry compliance
    • Outstanding written and verbal communication ability
    • Proficient in managing and evaluating complex, detailed information Understanding and application of principles, concepts, theories, and standards of scientific/technical field
    • Strong time and project management and prioritization skills, commitment, and perseverance with a drive for results
    • Foundational leadership skills and familiarity with supervision/ mentoring of others and oversight of their work
    • Strong leadership and collaboration experience in a team settingThriveSome of the vast rewards of working hereAs 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.
      • Full support and career-development resources to expand your skills, enhance your expertise, and increase your potential along your career journey
      • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
      • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, New Brunswick , Regulatory Writing Manager (Open to Remote), Executive , New Brunswick, New Jersey

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