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Amgen
Amgen
H1B vīzas sponsorsBiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
Amgen ir globāls biotehnoloģiju uzņēmums, kas izstrādā un komercializē no dzīvām šūnām ražotas zāles. Tā darbība ir vērsta uz smagām slimībām, tostarp slimībām ar ierobežotām ārstēšanas iespējām, un to atbalsta zinātniskie pētījumi un klīniskie izmēģinājumi. Uzņēmums ir saistīts ar sasniegumiem vēža ārstēšanā un aptaukošanās kontrolē, vienlaikus uzsverot ētisku pētniecību, pacientu drošību un vides ilgtspēju.
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Vakances uzņēmumā

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.

USAmerikas Savienotās Valstis
139 581 $ – 188 846 $ / gads
AttālinātiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuSatura autors

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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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