MSD
MSD

MSD saraton, yuqumli kasalliklar, yurak-qon tomir va metabolik holatlar, shuningdek, profilaktik tibbiy yordam kabi muhim sog‘liq muammolariga qarshi dori vositalari va vaksinalarni ishlab chiqadigan global biofarmatsevtika kompaniyasidir. Amerika Qo‘shma Shtatlari, Kanada va Puerto-Rikoda Merck & Co., Inc. nomi bilan tanilgan MSD ilmiy tadqiqotlarni ishlab chiqish va tijoriy tajriba bilan birlashtirib, odamlar va hayvonlar uchun tibbiy yechimlarni taqdim etadi.

Kompaniya faoliyati Inson salomatligi, Hayvonlar salomatligi hamda Tadqiqot va ishlanmalar yo‘nalishlarini qamrab oladi. Bu ilmiy, klinik, tijoriy, operatsion va korporativ jamoalarda faoliyat yurituvchi mutaxassislar uchun imkoniyatlar yaratadi. Dunyoning turli hududlarida faoliyat olib boradigan MSDdagi martaba imkoniyatlari tadqiqot, hamkorlik, inklyuzivlik va global salomatlik sohasidagi mas’uliyatli taraqqiyotga e’tiborni aks ettiradi.

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.

Tavsif

  • 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

Talablar

  • 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

Imtiyozlar

  • 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

O‘xshash ish o‘rinlari

Newstel Worldwide

Part-Time Danish-Speaking Customer Service Agent (Portugal, Remote)

Newstel Worldwide
201 – 500 Xodimlar
KonsaltingLogistikaMarketing

Provide remote customer support in Danish for Newstel’s multilingual BPO customers while meeting service and quality targets. This part-time role covers email, chat and phone enquiries from Portugal.

Ochish