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Amgen
Amgen
H1B vizasi homiysiBiotexnologiyaFarmatsevtika mahsulotlariSog‘liqni saqlash
Amgen tirik hujayralardan tayyorlangan dori vositalarini ishlab chiqadigan va tijoratlashtiradigan global biotexnologiya kompaniyasidir. Kompaniya faoliyati jiddiy kasalliklarga, jumladan davolash imkoniyatlari cheklangan holatlarga qaratilgan bo‘lib, ilmiy tadqiqotlar va klinik sinovlar bilan qo‘llab-quvvatlanadi. Amgen saraton kasalliklarini davolash va semirishni boshqarish sohasidagi yutuqlari bilan tanilgan, shuningdek, axloqiy tadqiqotlar, bemorlar xavfsizligi va ekologik barqarorlikka katta e’tibor beradi.
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Kompaniyadagi ish o‘rinlari

Senior Regulatory Writing Manager at Amgen (Remote, US)

Lead regulatory writing for complex Amgen product submissions, guiding document development and review across product teams. The role also shapes regulatory strategy, manages external writers, and mentors junior medical writers.

USAmerika Qo‘shma Shtatlari
139 581 $ – 188 846 $ / yil
MasofaviyTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaKontent yozuvchisi

Tavsif

  • Lead writing as the functional area representative on product teams.
  • Direct regulatory writing for complex product submissions.
  • Write or oversee regulatory documents, including clinical study reports, investigator brochures, responses to questions, protocols and amendments, informed consent forms, study tables, clinical overview addenda, eCTD Module 2 clinical summaries, briefing documents, and pediatric investigation plans.
  • Review and approve authored documents under applicable standard operating procedures.
  • Direct writing for complex submissions, including new and supplemental drug applications and biologics license applications.
  • Represent the function on Global Regulatory, Evidence Generation, and Global Safety teams, as well as the Label Working Group.
  • Contribute functional expertise to the Global Regulatory Plan and team objectives.
  • Supervise contract and freelance writers and mentor junior medical writers.
  • Lead initiatives within the department and across departments.
  • Develop document timelines.

Talablar

  • Doctorate and 2 years of directly related experience; master’s degree and 6 years; bachelor’s degree and 8 years; associate degree and 10 years; or high school diploma/GED and 12 years.
  • Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area.
  • At least 5 years of medical writing experience in the biotechnology or pharmaceutical industry.

Imtiyozlar

  • Comprehensive employee benefits, including a retirement and savings plan with generous company contributions.
  • Group medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
  • Discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off plans and company-wide shutdowns twice a year.
  • Flexible work arrangements, including remote options where possible.
  • Career development opportunities.
  • Work/life balance.

O‘xshash ish o‘rinlari

RELX

Remote Video ADA and Quality Control Reviewer and Writer

RELX
Malakali ishchi vizasi homiysiKonsaltingSog‘liqni saqlashSug‘urta
USAmerika Qo‘shma ShtatlariKYKentukkiMDMerilend
53 900 $ – 89 800 $ / yil
MasofaviyTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaKontent yozuvchisi

Review and improve patient education videos for accessibility, quality, plain language, and health literacy. Revise scripts, write short-form video content after training, and coordinate feedback with multidisciplinary production teams.

Ochish