Company Overview
Req ID: 287275
NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.
We have a REMS SME position available and REMOTE. If you are interested, please send resume today.
As a Risk Evaluation and Mitigation Strategy (REMS) SME, you should have:
- A deep appreciation of Drug safety, FDA REMS program requirements and key processes.
- Experience in setting up REMS program with exposure to multiple therapy areas Experience in regulatory submission standards and regulations
- Experience in design and implementation of REMS systems and tools.
- Strong foundations in drug safety and pharmacovigilance principles.
- Should have sound knowledge in Risk Evaluation and Mitigation Strategy (REMS), Periodic review reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs)
- Knowledge of Stakeholder workflows including but not limited to EHRs, Pharmacy, REMS administrators, patients, and wholesalers.
- Knowledge on current FDA regulations and guidance regarding REMS, including Medication Guides, ETASU, Shared REMS, Survey Methodologies, etc. Should have awareness of changes to/ new industry regulations Have knowledge of preparation of aggregate safety reports (e.g.; DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments
- Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI.
- Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.
- Good understanding of SDLC requirements and 21 CFR Part 11, GxP guidelines
- Prior experience of participating in designing and implementing REMS systems Experience of implementing or using CRM systems such as Salesforce, Dynamics (highly advantageous)
- Experience working with Medical CRM In this role, you will Be a product owner and a domain lead for REMS implementation on a Salesforce platform. Engage with client stakeholders in refining and prioritizing product features and detailed workflows for REMS implementation.
Lead a team of Business analysts and provide subject matter guidance through backlog grooming and product implementation
- Lead the end-to-end delivery of a Salesforce project, which shall involve planning, designing, building, integrating, testing, and deploying a Salesforce solution.
- Estimate effort at varying levels (e.g., high level, work package level) and using various techniques (e.g., cost per hour, story points)
- Define and work within an agile project governance framework (e.g., establish team cadence, run Scrum ceremonies, facilitate backlog refinement sessions, etc.)
- Develop, manage, and track project and sprint plans with detailed task distribution and execute projects using agile methodologies to ensure the project is delivered on time and beyond customer expectations.
- Lead and mentor the team in managing project scope and client expectations, leveraging relationships with external resources, and appropriately engaging them when needed.
- Build relationships with internal and external teams – contributing to broader goals and growth beyond the scope of the current project.
- Collaborate with the engineering team, in particular the Solution Architect, to define and validate the technical approach, strategy, and deliverables for the project.
- Evaluate and analyze information or data to present findings in a logical and easy-to-understand manner, tailored to the audience.
- Mentor project stakeholders, work on projects independently, participate as a team member, or lead less experienced team members and/or clients to successful project delivery.
- Lead, facilitate, and attend meetings, capture meeting minutes; provide project status reporting to internal and client leadership.
- Prepare and deliver client presentations and work products/prototypes.
- Develop, manage, and evaluate project financials.
- Proactively manage and mitigate risk, actions, issues and mitigate risk.
- Manage escalation channels and communication both internally and with the client.
- Operate effectively in a multi-vendor environment.
Skills And Experience
- 10+ years of experience in Agile Software development as a Project or Program Manager
- Experience leading projects consisting of 10 or more people, or $1MM+ in budget.
- Must have executed at least 5 full life cycle, end-to-end Salesforce implementations.
- Experience in all phases of product, software, and testing lifecycles
- Ability to serve as a liaison between both business and technical teams to drive effective, timely solutions that fulfil both strategic and operational needs.
- Strong and effective communication skills: Ability to lead and communicate with a wide variety of team members and client roles + drive clarity on roles and accountability.
- Strong logical and analytical problem-solving skills; a rigorous approach to project management to deliver enterprise-level projects in ambiguous environments.
- Extensive experience leading all Agile ceremonies including sprint grooming, planning, stand-ups, reviews/demos, and retrospectives.
- Strong track record of proficiency in Agile implementations using JIRA with the ability to quickly drive numerous high-quality releases into production.
- A history of mentoring and/or teaching others around work plan development, progress tracking, time tracking, status reporting, financial and risk management
Experience creating Road Maps that provide clients with a vision of their implementation and helping them to transform their business processes be executing against those roadmaps
About NTT DATA
NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize, and transform for long-term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo. Visit us at us.nttdata.com.
NTT DATA is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is
(65 TO 75 hourly). This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications. This position may also be eligible for incentive compensation based on individual and/or company performance.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits
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