Research Assistant providing patient care activities and supporting research projects at Cleveland Clinic. Collaborating with a team to ensure effective delivery of study - related tasks.
About the role
- Associate Principal Scientist at Organon overseeing regulatory CMC strategies for small molecules and biological products. Driving compliance and project milestones throughout product lifecycle in a dynamic healthcare environment.
Responsibilities
- Serve as the CMC Product Lead for assigned products
- Lead development and execution of global product and project regulatory strategies
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components
- Provide regulatory leadership to product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners for compliant execution of change management
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Deliver all regulatory milestones for assigned products across the product lifecycle
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least seven years of relevant experience including biological/pharmaceutical research, manufacturing, analytical testing or a related field OR advanced degree with at least four years of relevant experience
- Proven experience in critically reviewing detailed scientific information
- Demonstrated superior oral and written communication skills in multicultural settings
- Strong listening skills
- Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance)
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
Benefits
- Health benefits including medical, prescription drug, dental, and vision coverage
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Retirement savings plan
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