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MSD
Sponsor pentru viza H1BAsistență medicalăBiotehnologieLogistică

MSD este o companie biofarmaceutică globală care dezvoltă medicamente și vaccinuri pentru provocări majore din domeniul sănătății, inclusiv cancerul, bolile infecțioase, afecțiunile cardiovasculare și metabolice, precum și îngrijirea axată pe prevenție. Cunoscută sub numele Merck & Co., Inc. în Statele Unite, Canada și Puerto Rico, MSD îmbină cercetarea științifică cu expertiza în dezvoltare și comercializare pentru a oferi soluții de îngrijire a sănătății oamenilor și animalelor.

Activitatea sa acoperă domeniile Sănătății Umane, Sănătății Animalelor și Cercetării și Dezvoltării, creând oportunități pentru profesioniști din echipe științifice, clinice, comerciale, operaționale și corporative. Prin activitățile desfășurate în regiuni din întreaga lume, carierele la MSD reflectă accentul pus pe cercetare, colaborare, incluziune și progres responsabil în domeniul sănătății globale.

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Locurile de muncă ale companiei

Associate Director, Regulatory Affairs CMC Digital Innovation – MSD Hybrid

Lead digital and AI innovation across Regulatory CMC for MSD medicines, vaccines, and animal health products. Connect research, manufacturing, and regulatory operations through automation, modern authoring, and integrated technology solutions.

USStatele Unite ale AmericiiNJNew JerseyPAPennsylvania
142.400 $ – 224.100 $ / an
HibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăConformitate

Descriere

  • Create digital and AI solutions that improve Regulatory CMC workflows
  • Act as the subject matter expert for Regulatory CMC digital innovation and AI
  • Advance AI-enabled regulatory authoring, including innovations for Module 2 and Module 3
  • Develop practical job aids and identify opportunities for generative AI-assisted drafting
  • Evaluate emerging AI, machine learning, and digital technologies for Regulatory CMC use
  • Lead cross-functional work spanning AI authoring, process automation, regulatory intelligence, and digital transformation
  • Support the CMC digital and AI operating model while aligning local initiatives with enterprise strategy
  • Collaborate with Regulatory CMC Systems and Operations on digital solutions for platforms such as Veeva
  • Own designated digital tools and platforms, including the ERA App
  • Monitor CMC digital priorities and communicate progress
  • Work across research, manufacturing, and regulatory divisions to identify opportunities and build integrated solutions
  • Promote enterprise AI adoption through champion networks, feedback channels, change management, and training
  • Lead and mentor digital project teams, including GRACS CMC summer intern initiatives
  • Report to the Executive Director of Regulatory CMC Digital Innovation
  • Travel up to 10%

Cerințe

  • Bachelor’s degree or equivalent in a scientific, technical, or regulatory discipline; chemistry, biology, pharmacy, computer science, or data analytics preferred
  • At least five years of experience in the pharmaceutical or biotechnology industry
  • Strong experience in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations
  • Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI or LLM solutions in a regulated business environment
  • Track record of delivering enterprise solutions that improve business outcomes
  • Experience with technical change management, including repeatability assessments, job aids, and training materials
  • Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
  • Ability to collaborate effectively in a matrix organization spanning research, manufacturing, and IT
  • Strong organizational and project coordination skills, with the ability to manage multiple concurrent initiatives
  • Knowledge of change management, eCTD, emerging technologies, manufacturing processes, project leadership, Regulatory Affairs management, Regulatory CMC, regulatory compliance, regulatory documents, regulatory operations, regulatory reporting, regulatory strategy development, regulatory submissions, and stakeholder partnerships
  • Willingness to travel up to 10%
  • Must reside in the United States or Puerto Rico
  • Visa sponsorship is not available

Beneficii

  • Annual bonus and long-term incentive, where applicable
  • Medical, dental, and vision coverage
  • Additional insurance benefits for employees and their families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation time
  • Compassionate and sick leave
  • Hybrid work arrangement
  • Mentorship and career development opportunities
  • Relocation assistance is not provided

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