Regulatory Affairs Lead
1 day ago
Overview:
MEDPACE, INC. is a full-service contract research organization (CRO) offering Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. We have over 5,000 employees across 40+ countries.
Job Description:
This Clinical Safety Manager position plays a critical role in the pharmacovigilance process at Medpace, working closely with clients and internal stakeholders to provide expert safety knowledge. Key responsibilities include managing clinical safety activities and multiple large programs, establishing and maintaining strong relationships with clients, and overseeing clinical safety case management and aggregate reporting responsibilities.
Responsibilities:
- Lead clinical safety program planning, execution, and delivery to ensure compliance with regulations and client expectations
- Develop and implement comprehensive safety management plans tailored to client needs
- Prioritize and manage competing demands to meet tight deadlines and deliver high-quality results
- Cultivate and maintain strategic partnerships with key stakeholders to drive business growth and enhance customer satisfaction
- Drive process improvements and innovation to enhance efficiency, productivity, and overall performance
Requirements:
- Bachelor's degree or equivalent in life sciences, healthcare, or related field
- Minimum 5 years' experience in clinical safety, pharmacovigilance, or related field
- Proven track record of delivering high-quality results, exceeding client expectations, and driving business growth
- Strong leadership, communication, and collaboration skills
- Ability to adapt quickly to changing priorities and circumstances
- Familiarity with relevant regulatory frameworks, guidelines, and industry best practices
$120,000 per year. Competitive salary and benefits package, flexible work environment, and employee recognition programs make this an attractive opportunity for talented professionals.
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