Manager, Global Development Process & Procedures Operations

🔥 43 minutes ago

🇺🇸 United States – Remote

💵 $114.8k - $187.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Leads/facilitates Process and Procedural Development projects with the respective document owner/Subject Matter Experts, to support development/improvement of the related process (New and Revised) • Coordinates the development, review, content/comment management and approval of the Procedural Document with the document owner/SME including the writing of the procedural and associated documents, as applicable • Initiates and manages cross-functional review cycles ensuring the appropriate SME reviewers • Verifies procedural documents do not conflict with other procedures or with regulatory requirements • Liaises with the Training function and the document owner to ensure that training requirements are implemented and current within the REGN Learning Management System

🎯 Requirements

• Strong Procedural writing experience within the pharmaceutical industry • Ability to translate operational needs into a process map and procedural document • Proven ability to work effectively across multiple stakeholders • Effective communicator (written and oral) • Ability to work independently • Proven track record to manage multiple responsibilities and priorities • Experience in working in or with Pharmacovigilance and knowledge of Regulatory Affairs, Medical Affairs, Clinical Development, Quality, and/or Product Complaints • Analytical skills with ability to navigate through scenarios • Experience in procedural document principles, process design, and process improvements is required • Attention to detail with demonstrated organizational and emotional intelligence/awareness • Knowledge of Pharmacovigilance regulatory requirements • Bachelors Degree and 7+ years of relevant experience

🏖️ Benefits

• annual bonuses or other incentive plans • equity awards • pension or retirement benefits • 401(k) company match • health and wellness programs • fitness centers • insurance benefits (e.g. medical, dental, vision, life and disability) • paid time off • family support benefits