MSD
MSD

MSD — қатерлі ісік, жұқпалы аурулар, жүрек-қантамыр және метаболизм аурулары, сондай-ақ алдын алуға бағытталған медициналық көмек сияқты негізгі денсаулық мәселелеріне арналған дәрілер мен вакциналарды әзірлейтін жаһандық биофармацевтикалық компания. Америка Құрама Штаттарында, Канадада және Пуэрто-Рикода Merck & Co., Inc. атауымен танымал MSD ғылыми зерттеулерді әзірлеу және коммерцияландыру салаларындағы тәжірибемен ұштастырып, адамдар мен жануарларға арналған денсаулық сақтау шешімдерін ұсынады.

Компанияның қызметі Адам денсаулығы, Жануарлар денсаулығы және Ғылыми зерттеулер мен әзірлемелер бағыттарын қамтиды. Бұл ғылыми, клиникалық, коммерциялық, операциялық және корпоративтік командаларда жұмыс істейтін мамандарға мүмкіндіктер береді. Әлемнің әртүрлі өңірлерінде қызмет атқаратын MSD-дегі мансап мүмкіндіктері зерттеуге, ынтымақтастыққа, инклюзияға және жаһандық денсаулық саласындағы жауапты ілгерілеуге деген ұстанымды көрсетеді.

Associate Director, Oncology Regulatory Liaison

Lead regulatory strategy and agency engagement for oncology products at MSD. Support global registrations, lifecycle management, submissions, and compliant product development.

Сипаттама

  • Support oncology products within a regulatory affairs team
  • Partner with global regulatory leads on registration and product-maintenance strategies
  • Contribute to marketing applications, IND submissions, pediatric plans, and annual or periodic reports
  • Track, draft, coordinate, and review responses to regulatory agency requests
  • Prepare agency background packages and marketing application documents
  • Communicate with regulatory agencies and participate in agency meetings as needed
  • Contribute to global regulatory teams and cross-functional meetings
  • Evaluate regulatory guidance, precedents, and competitive intelligence
  • Help prepare regulatory strategy documents
  • Collaborate with Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, clinical research, and non-clinical safety teams
  • Support quality compliance and lifecycle management for oncology programs
  • Contribute to label development
  • Support regulatory process improvement initiatives
  • Handle regulatory administrative activities as needed

Талаптар

  • Bachelor’s degree and at least 5 years of relevant pharmaceutical industry experience, or a master’s degree and at least 2 years of relevant experience, or an M.D., Ph.D., or related doctorate in biological science, chemistry, or a related discipline with relevant experience
  • Experience with drug development
  • Previous regulatory experience involving interaction with a major regulatory agency
  • Excellent written and verbal communication skills
  • Strong organization and the ability to manage varied activities across multiple projects simultaneously
  • Flexibility
  • Strong scientific and analytical capabilities with close attention to detail
  • Oncology product experience is highly preferred
  • Eligibility to reside in the United States and Puerto Rico
  • Visa sponsorship is not available
  • Willingness to travel up to 10%
  • A valid driving license is not required

Артықшылықтар

  • Annual bonus
  • Long-term incentive, where applicable
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation leave
  • Compassionate leave
  • Sick leave
  • Hybrid work arrangement

Ұқсас жұмыс орындары

Chemin AI

Mandarin and Korean Translation Reviewer

Chemin AI

Review Korean e-commerce content against Traditional Chinese translations for Kaya by Chemin, checking accuracy, fluency, and meaning against quality guidelines.

Ашу
Delegate CX

Remote Accounting Specialist – Hospitality

Delegate CX

Manage accounts payable and receivable, billing, collections, and financial records for U.S. hospitality clients. This full-time, home-based role in the Philippines uses QuickBooks, Excel, and other accounting systems.

Ашу
Remote Recruitment

Remote Billing Administrator in South Africa

Remote Recruitment

Handle invoicing, billing queries, reconciliations, and month-end reporting for a UK business while working remotely from South Africa.

Ашу
Agilent Technologies

Field Service Engineer, Asset Performance Management — Japan

Agilent Technologies

Install, maintain, and repair Agilent hardware, software, and network solutions. Provide on-site customer support and travel throughout Japan 100% of the time.

Ашу
Agilent Technologies

Field Service Engineer, Asset Performance Management (Japan)

Agilent Technologies

Install, maintain, and troubleshoot enterprise asset performance systems for Agilent customers. The role includes integrated solution delivery, technical training, and 100% travel.

Ашу
Hewlett Packard Enterprise

Senior Channel Presales Technical Architect, Canada

Hewlett Packard Enterprise

Guide channel partners in designing and selling HPE storage and data protection solutions. Build technical advocacy, grow the opportunity pipeline, and support customer engagements.

Ашу
Hewlett Packard Enterprise

Senior Channel Presales Technical Architect, Storage — HPE Canada Remote

Hewlett Packard Enterprise

Help HPE channel partners position, design, and sell storage and data protection solutions. Support solution architecture, demonstrations, proofs of concept, pipeline development, and partner technical advocacy.

Ашу
Hewlett Packard Enterprise

Channel Presales Technical Architect, Canada

Hewlett Packard Enterprise

Guide HPE channel partners in positioning, designing, and delivering storage and data protection solutions. Build partner technical capability, develop pipeline, and help secure competitive wins.

Ашу
Xero

Customer Experience Data Analyst

Xero
1 001 – 5 000 Қызметкерлер
H1B визасының демеушісіB2BSaaS

Create reporting and workforce insights for Xero’s Customer Experience and Payment Operations teams. Use Tableau and Zendesk Explore to inform business reviews, headcount planning, and senior leadership decisions.

Ашу
Hewlett Packard Enterprise