Associate Principal Scientist, Regulatory Affairs, Chemistry, Manufacturing, and Control
Organon
Principal Scientist – Outcomes Research
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Rahway • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $187,000 - $294,400 per year
Job Level
Lead
About the role
- Partners with Medical Affairs counterparts to develop, execute and deliver on the Value and Implementation (V&I) plan.
- Helps achieve / sustain reimbursement and market access for the program and indications under their responsibility.
- Critically assesses drivers and barriers to reimbursement and market access, and provides input into clinical, regulatory, payer/access, marketing and evidence generation strategies and programs.
- In collaboration with internal teams and external partners, designs studies; authors study protocols; and develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications.
- Responsible for study-related contracting, budgets, and vendor/partner management and ensures study conduct is aligned with company Policies and standard operating procedures (SOPs) and world-wide regulations and standards, including Good Pharmacoepidemiology Practice (GPP) for applicable work.
- Develops American Managed Care Pharmacy (AMCP) dossiers for U.S. payers and Global Value Dossiers.
- Supports country affiliates to understand local evidence generation needs and customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements.
- Works closely with cross-functional teams to effectively communicate outcomes research and real-world evidence data internally and to external stakeholders.
- Maintains awareness of new scientific and methodological developments within therapeutic area.
- Builds relationships with scientific experts worldwide.
- Presents outcomes research data at national and international congresses and publishes articles in scientific journals.
Requirements
- Doctoral degree (PhD, MD, DrPH, ScD, PharmD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, pharmacoeconomics, pharmacy administration)
- Required Skills: Biostatistics, Data Management, Epidemiology, Health Economics, Health Technology Assessment (HTA), Medical Economics, Outcomes Research, Researching, Stakeholder Relationship Management, Strategic Planning
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
BiostatisticsData ManagementEpidemiologyHealth EconomicsHealth Technology AssessmentMedical EconomicsOutcomes ResearchResearchingStatistical AnalysisStudy Design
Soft skills
Stakeholder Relationship ManagementStrategic PlanningCommunicationCollaborationCritical ThinkingProblem SolvingInterpersonal SkillsPresentation SkillsProject ManagementVendor Management
