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Manager, IT App Dev Commercial Application Systems

Manager, IT App Dev Commercial Application Systems
Position Summary
The Manager, IT Applications Development (Commercial Application Systems) will lead multiple projects to implement, develop and maintain application systems supporting all Commercial Operations initiatives. This individual will manage the full development lifecycle, change management, and troubleshooting of any new or existing Commercial applications (GxP and non-GxP systems, websites, mobile apps, SaaS, etc.) The individual in this role will lead these projects from inception through completion, while adhering to project scope, schedule, quality and budget. They will proactively monitor and manage project status, issues, risks, and dependencies. The Manager will manage the delivery of all CSV (Computer System Validation) and SDLC (Systems Development Life Cycle) documentation including SOP's, Project Charters, Risk Assessments, User Requirements Specifications, Data Migration Plans, Qualification Test Protocols, Test Scripts and Training Plans. The Manager, IT Applications Development must possess strong communication skills and be able to work with both technology and business partners across the organization in a collaborative way. This role is one that requires team leadership, business acumen, and strong relationship management skills.
Roles and Responsibilities
The Manager, IT Applications Development will be responsible for:
Working closely with the Commercial Operations business managers and system administrators to deliver quality solutions for specified requirements
Managing multiple, high-complexity projects within the constraints of scope, quality, time, and cost to deliver specified requirements and meet customer satisfaction
Defining risk-based strategies for validation of computerized systems, and authoring and reviewing end-to-end Computerized Systems Validation documentation
Ensuring compliance to industry standards like GAMP5, and FDA 21 CFR Part 11 on electronic records, electronic signatures, etc.
Ensuring the project and business requirements are properly defined
Identifying areas for process improvements, then proposing and managing solutions
Building project schedules and identifying, tracking, managing and resolving project issues
Regularly communicating project progress and status to all stakeholders
Identifying, managing and mitigating project risk
Proactively managing scope to ensure that only what was agreed to is delivered, unless changes are approved through scope management
Defining and collecting metrics to give a sense for how the project is progressing and whether the deliverables produced are acceptable
Proactively disseminating project information to all stakeholders
Reconciling conflicts within and between staff regarding resources, deadlines, and standards
Managing the overall work plan to ensure work is assigned and completed on time and within budget
Requirements
Bachelor's degree in computer science, computer information systems, or a related field (Equivalent education and work experience may be substituted.)
PMP/PMI or equivalent certification preferred.
5+ years of experience leading projects that implement, develop and manage computer systems in regulated and non-regulated environments
Experience implementing and supporting a CRM (Customer Relationship Management) solution in the pharmaceutical industry
Experience supporting an in-house patient call center platform
Strong understanding of Computer System Validation - 21 CFR part 11, Annex 11 and validated document management repositories
Experience with internal and external auditing, and quality system related inspections for computerized systems
Experience in developing a Master Validation Plan, validation scripts, validation reports, all documentation required during the CSV implementation process
Experience leading projects and programs within and outside IT, as well as projects and programs that involved external providers
Demonstrated ability to work effectively with cross-functional staff, including IT, project managers, and multiple levels of leadership, business partners, and vendors
Demonstrated ability to manage risks, issues, assumptions, and dependencies at program and project levels
Demonstrated ability to identify and understand problems, work collaboratively with team to bring to resolution, and balance when to escalate issues in order to meet project timelines.
Experience and Skills
Possess excellent verbal, written, and interpersonal communication skills
Strong organizational and personal discipline skills
Ability to interpret data and disperse information to others
Good understanding of project management processes and general lifecycle methodologies
Knowledge of MS Project
Expert level ability in MS Office tools (MS Word, MS Excel, MS PowerPoint, and MS Visio)
Ability to multitask, manage stress and handle conflict resolution
Experience working on global projects with global teams
Travel
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