MSD

Senior Scientist, Regulatory Affairs

MSD

full-time

Posted on:

Location Type: Hybrid

Location: North Wales • New Jersey • Pennsylvania • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $106,200 - $167,200 per year

Job Level

Senior

About the role

  • developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines
  • developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
  • assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
  • providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
  • serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams
  • leading cross-functional teams to develop, review and approve Core and Local Labeling documents

Requirements

  • Bachelor’s degree in a scientific or medically related discipline
  • Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance)
  • Experience in leading cross-functional labeling team (including senior management)
  • Ability to assimilate clinical and scientific information, labeling precedent and competitor labeling, and present it concisely
  • Understanding of medical concepts and terminology
  • Project management skills with the ability to handle multiple projects and prioritize work accordingly
  • Proactive problem-solving ability with the ability to make appropriate recommendations/decisions
  • Attention to detail and accuracy
  • Ability to influence and negotiate
Benefits
  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
labeling experienceregulatory requirementsCore LabelingLocal Labelingmedical conceptsscientific informationproject management
Soft Skills
problem-solvingattention to detailinfluencenegotiationcommunicationleadershiporganizational skills
Certifications
Bachelor’s degree in a scientific discipline