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Amgen
Amgen
Sponsor pentru viza H1BAsistență medicalăBiotehnologieProduse farmaceutice
Amgen este o companie globală de biotehnologie care dezvoltă și comercializează medicamente obținute din celule vii. Activitatea sa se concentrează asupra bolilor grave, inclusiv asupra afecțiunilor pentru care opțiunile de tratament sunt limitate, fiind susținută de cercetare științifică și studii clinice. Compania este asociată cu progrese în tratamentul cancerului și gestionarea obezității, punând accent pe cercetarea etică, siguranța pacienților și sustenabilitatea mediului.
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Locurile de muncă ale companiei

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.

USStatele Unite ale Americii
139.581 $ – 188.846 $ / an
RemoteNormă întreagăSeniorLimbă Obligatorie: englezăRedactor de conținut

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

  • 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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