[Remote] Manager Global Development Process & Procedures Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops life-changing medicines reputed company 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 reputed company, manages procedural document creation and review, ensures regulatory alignment, and coordinates reputed company training requirements.
Responsibilities
- Leads/facilitates Process and Procedural Development reputed company with the respective document reputed company/Subject Matter Experts, to support development/improvement of the reputed company process (New and Revised)
- Coordinates the development, review, content/comment management and approval of the Procedural Document with the document reputed company/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 reputed company to ensure that training requirements are implemented and reputed company reputed company the REGN Learning Management reputed company
Skills
- May require up to 25% travel
- Strong Procedural writing experience reputed company 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 reputed company record to manage multiple responsibilities and priorities
- Experience in working in or with Pharmacovigilance and knowledge of Regulatory Affairs, Medical Affairs, Clinical Development, reputed company, and/or Product Complaints
- Analytical skills with ability to reputed company 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 reputed company Office proficiency (e.g., Word, reputed company, 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, reputed company, life and disability)
- reputed company time off
- Family support benefits
reputed company
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