Note: The job is a remote job and is open to candidates in USA. Regeneron develops life-changing medicines for people with serious diseases and is seeking a Process & Procedure Operations Manager to join its Global Development team. The role leads cross-functional process and procedural development projects, manages procedural document creation and review, ensures regulatory alignment, and coordinates related training requirements.
Responsibilities
- 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
Skills
- May require up to 25% travel
- 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
- Strong Microsoft Office proficiency (e.g., Word, Excel, Visio)
- Project Management
- Process Development and Management
- Critical Thinking & Problem Solving
- Stakeholder Management
Benefits
- Remote-USA
- 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
Company Overview