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Pfizer
Pfizer
H1B vizos rėmėjasFarmacijos produktaiKonsultavimasRinkodara
„Pfizer“ yra pasaulinė farmacijos bendrovė, daugiausia dėmesio skirianti vaistų ir sveikatos priežiūros paslaugų, padedančių palaikyti sveikatą visą gyvenimą, kūrimui ir teikimui. Jos veikla apima mokslines inovacijas ir saugių, veiksmingų bei įperkamų gydymo būdų prieinamumo didinimą, ypatingą dėmesį skiriant vėžio ir kitų reikšmingų sveikatos sutrikimų gydymo pažangai. Bendrovės veikla gali būti aktuali specialistams, besidomintiems karjera farmacijos tyrimų, sveikatos priežiūros ir susijusių komercinių funkcijų srityse.
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Senior Associate Scientist, GMP Investigations and Compliance

Support Pfizer’s medicines and vaccines by strengthening GMP investigations and compliance across R&D sites. Write investigations, assist with audits, and use quality data to drive improvements.

USJungtinės ValstijosMAMasačusetsasMOMisūris
68 600 $ – 114 300 $ / metai
HibridinisVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Aprašymas

  • Prepare clear, timely investigations using Pfizer quality systems.
  • Check investigations against applicable quality and compliance standards.
  • Encourage consistent use of root cause analysis and human error reduction methods.
  • Assist with internal and external audits and inspections, coordinating requests and responses.
  • Assess compliance with global procedures.
  • Review compendia and regulatory requirements.
  • Take part in internal quality forums.
  • Evaluate investigation, audit, and inspection data to identify, recommend, and implement improvements.
  • Select solutions for moderately complex issues and follow procedures under general guidance.
  • Help meet work group objectives and collaborate with colleagues.
  • Manage priorities to meet project deadlines and contribute as a team member.

Reikalavimai

  • Bachelor’s degree in microbiology, molecular biology, biochemistry, or a related field and at least three years of GMP microbiology laboratory experience; alternatively, an MBA or MS and at least one year of experience.
  • Advanced technical writing ability.
  • Strong documentation skills and careful attention to detail.
  • Experience working in Good Manufacturing Practices (cGMP) settings.
  • Experience with GMP microbiology investigations.
  • Experience with laboratory data platforms such as LIMS, eQMS, and GDMS.
  • Ability to work effectively with peers and leaders on cross-site, multidisciplinary teams.
  • Ability to find relevant information in scientific literature.
  • Ability to manage timelines and deliverables independently.
  • Strong organizational skills and demonstrated attention to detail.
  • Experience using common AI tools, including generative tools such as ChatGPT or Microsoft Copilot, to solve problems and improve productivity.
  • Curiosity about how AI tools can improve outcomes, along with understanding of responsible AI practices, including risk management and ethical use.
  • Must be authorized to work in the United States for any employer.
  • U.S. work visa sponsorship is unavailable for this role, now and in the future.
  • Permanent U.S. work authorization is required.

Privalumai

  • 401(k) plan with Pfizer matching contributions.
  • Additional Pfizer retirement savings contribution.
  • Paid vacation, holidays, and personal days.
  • Paid caregiver, parental, and medical leave.
  • Medical, prescription drug, dental, and vision coverage.
  • Relocation support may be offered depending on business needs and eligibility.
  • May participate in Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.

Susiję darbai

Medtronic

Medical Device Regulatory Affairs Manager

Medtronic
H1B vizos rėmėjasGamybaSveikatos draudimasSveikatos priežiūra
USJungtinės ValstijosCTKonektikutasMAMasačusetsas
120 800 $ – 181 200 $ / metai
HibridinisVisas etatasVidutinis lygisVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Lead regulatory strategy, submissions, and compliance for Medtronic medical devices, with a focus on U.S. and EU approvals. Guide the Stapling Regulatory Affairs team and work across product development and business functions.

Atidaryti
Medtronic

Regulatory Affairs Manager, Medical Devices — Medtronic (Hybrid, North Haven, CT)

Medtronic
H1B vizos rėmėjasGamybaSveikatos draudimasSveikatos priežiūra
USJungtinės ValstijosCTKonektikutasMAMasačusetsas
120 800 $ – 181 200 $ / metai
HibridinisVisas etatasVidutinis lygisVyresnysis specialistasPrivaloma Kalba: anglųAtitiktis

Lead regulatory submissions, approvals, and compliance for Medtronic’s Surgical Operating Unit. Guide regulatory teams and cross-functional product strategies across the product lifecycle.

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Johnson & Johnson

Senior Regulatory Affairs Manager, Biomaterials

Johnson & Johnson
H1B vizos rėmėjasBiotechnologijaFarmacijos produktaiSveikatos priežiūra
USJungtinės ValstijosMAMasačusetsasPAPensilvanija
117 000 $ – 201 250 $ / metai
HibridinisVisas etatasVyresnysis specialistasVadovasPrivaloma Kalba: anglųAtitiktis

Lead regulatory strategy for Johnson & Johnson Orthopaedics’ biomaterials, biologics, and combination product programs. Oversee submissions, due diligence, and regulatory support for external innovation partnerships.

Atidaryti
Johnson & Johnson

Senior Manager, Regulatory Affairs – Biomaterials | Johnson & Johnson

Johnson & Johnson
H1B vizos rėmėjasFarmacijos produktaiSveikatos draudimasSveikatos priežiūra
USJungtinės ValstijosMAMasačusetsasPAPensilvanija
117 000 $ – 201 250 $ / metai
HibridinisVisas etatasVyresnysis specialistasVadovasPrivaloma Kalba: anglųAtitiktis

Lead regulatory strategy for biomaterials, biologics, and combination products at Johnson & Johnson Orthopaedics. Guide submissions, external innovation reviews, and global approvals from development through product lifecycle management.

Atidaryti