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Amgen
Amgen
H1B वीज़ा प्रायोजकऔषधियाँजैव प्रौद्योगिकीस्वास्थ्य सेवा
Amgen एक वैश्विक जैव-प्रौद्योगिकी कंपनी है, जो जीवित कोशिकाओं से बनी दवाओं का विकास और व्यावसायीकरण करती है। इसका काम गंभीर बीमारियों पर केंद्रित है, जिनमें ऐसे रोग भी शामिल हैं जिनके उपचार के विकल्प सीमित हैं। कंपनी वैज्ञानिक अनुसंधान और नैदानिक परीक्षणों के आधार पर काम करती है तथा कैंसर उपचार और मोटापे के प्रबंधन में प्रगति से जुड़ी है। Amgen नैतिक अनुसंधान, रोगी सुरक्षा और पर्यावरणीय स्थिरता पर भी जोर देती है।
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कंपनी की नौकरियाँ

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.

USसंयुक्त राज्य
$1,39,581 – $1,88,846 / वर्ष
रिमोटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीकंटेंट लेखक

विवरण

  • 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.

आवश्यकताएँ

  • 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.

लाभ

  • 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.

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