| : Title: Process Development Manager - Regulatory Affairs || Location: 100% Remote || Visa: USC and GC at Remote, Remote, USA |
| Email: [email protected] |
| Hi, Hope you are doing great! Please find the requirement below , If you find yourself comfortable with the requirement please reply back with your updated resume and I will get back to you or I would really appreciate if you can give me a call back at my contact number 302-485-1712 Title: Process Development Manager - Regulatory Affairs Location: 100% Remote Visa: USC and GC Interview: Phone and Video Duration: 12+ Months LinkedIn, SSN, DOB Job Summary: The Manager, Regulatory Process Development (RPD) is responsible for executing an effective model for the development of E2E processes which connect across GRA capabilities. This role will be focused on the identified opportunities for streamlining and standardizing regulatory processes, reducing cycle times, and improving overall efficiency. This role will execute implementation of an E2E process management model across GRA capabilities, which can be effectively integrated with the HPT technology delivery model. Responsibilities: Support the development and execute the implementation of a global regulatory process strategy that aligns with overall business objectives. Support the generation and review of an E2E process management model, including connectivity with partner organizations for shared process ownership (e.g., Clinical, Safety, Supply Chain), and help reaching alignment with key stakeholders on implementation. Apply consistent process design methodologies/frameworks (six sigma, Lean, BPM) to identify opportunities for streamlining/standardizing regulatory processes, reducing cycle times, improving overall efficiency, and helping to align overlapping sub-processes across workflows. Escalate and support resolving issues with resource availability to GRA leadership members. Interact with cross-functional teams to implement process development initiatives and monitor progress against goals and objectives, provide GRA Governance support to identify, prioritize and sequence initiatives. Collaborate with stakeholders to develop and implement process metrics and track progress against established benchmarks. Interact with all GRA functions and relevant partners in E2E process development activities Provide support on regulatory process development best practices and emerging trends. Engage and collaborate with the team of process development experts to support the implementation of process initiatives. Work with Business Outcomes Delivery and IT to ensure compatibility of the E2E process management model with the HPT technology delivery model Support appropriate change management to drive sustainability of the E2E process management model. Qualifications: Bachelor's degree in scientific/technical discipline, regulatory affairs, life scienes or a related field 7+ years overall work experience 3+ years in pharma or healthcare industry, with directly relevant experience in process design, modeling and optimization Moderate analytical skills and the ability to work with complex regulatory data Experience executing strategic planning initiatives and working with complex projects Moderate analytical skills with complex data Experience with BPM, data visualization tools and business intelligence software Project management skills Ability to build Business Case with ROI and Value Drivers calculation Experience working in a global, matrixed organization Excellent communication and collaboration skills Demonstrated ability to interact with cross-functional teams and work with complex projects Strong organizational and time-management skills Nice to have qualifications: 10+ years' experience in regulatory affairs or a related field, with a strong background in process optimization and change management Internal and external resource management experience People or team management experience Experience in designing process in alignment with IT solutions a plus Black/Green Belt Related industry certification in process design, mapping, and/or business analysis Thanks And Regards Khokan Kaviraj Phone: 302-485-1712 Email: [email protected] Hangout: [email protected] Linked In: https://www.linkedin.com/in/khokan-kaviraj-582655166/ Accroid Inc. 1007 Orange ST 4th FL 1651 Wilmington, DE 19801 -- Keywords: information technology green card Delaware Florida |
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| Fri Jan 26 21:55:00 UTC 2024 |