Job Location: IL - Chicago, MA - Boston, NJ - Florham Park, NY - New York, PA - Philadelphia
Regional Description: Northeast
Job Number: 00603084 00603084_en
Pharma R&D Regulatory Technology Consulting Manager
Locations: Location is negotiable. Client work will primarily take place in NY/NJ, Philadelphia, Boston and Chicago. If you are not located in one of these areas, travel will be more extensive.
At the highest level, Accenture Consulting professionals are industry experts with the insights and capabilities to transform the world's leading companies. Our professionals are responsible for:
• Orchestrating and bringing together expertise from across the entire organization—strategy, consulting, digital, technology and operations—to deliver value to clients
• Building and sustaining long-term client relationships
• Selling the full breadth of Accenture’s services
• Selling and delivering an expanded range of management and technology consulting services.
Our R&D business provides innovative solutions that help pharmaceutical companies focus on the science of getting products to patients faster - across research, clinical, regulatory, pharmacovigilance and medical affairs. We help our clients with their priorities:
• Focusing on patient engagement throughout development
• Advancing the next generation of R&D operating models resulting in better collaboration
• Driving scientific and operational excellence and enabling efficient information analysis
• Harnessing the digital R&D revolution, using real world data to address customer needs
ARDS is a global industry business service and spans all five of Accenture’s businesses (Strategy, Consulting, Technology, Operations, Digital), which allows us to bring integrated end-to-end solutions to our clients.
R&D Consulting professionals work closely with our clients to design and implement strategies, operating model changes, and business transformations that can help enhance their performance. Doing so requires our people to understand how business, technology and operations intersect. Our deep understanding of our clients’ industry and our global perspective on progressive business trends and emerging technologies enable us to drive and deliver transformational change.
The Pharma R&D Regulatory Technology Consulting Manager will provide consulting services for regulatory organizations within our Life Sciences portfolio of clients, with particular focus on industry best practices, process innovations and/ or redesign and regulatory technologies to enable these processes.
The individual in this role is responsible for working directly with regulatory business clients and their IT business partners to:
• Assess and improve regulatory affairs and regulatory operations processes and their underlying technology platforms
• Provide regulatory information management subject matter expertise in areas such as document management, requirements management, submission planning and tracking, submission publishing, and registration and commitment tracking.
• Typical projects consist of definition of a regulatory IT roadmap, assessment of current regulatory technology footprint and/ or design and implementation of regulatory systems to achieve a desired future state.
• Other projects may involve the design, development and implementation of regulatory operating models, including vision and strategy, business processes, organizational and governance structures, supporting tools and templates, and performance metrics, along with change management to support these efforts.
The Pharma R&D Regulatory Technology Consulting Manager will be responsible for the day to day management of all activities, often including those of clients and vendors. These responsibilities include developing and managing schedules/timelines, issues and risks, scope and budget. The Manager is the Accenture party accountable for delivery of a solution to our clients, and is usually the day-to-day lead on a project for all parties. Additional responsibilities will include developing Accenture Consultants and Analysts, identifying and developing future business opportunities, helping manage client relationships and accounts, and contributing to the development of Accenture's Accelerated R&D Services consulting practice by taking on a practice development role.
• 4+ years of regulatory consulting experience in an IT/systems development environment
• 4+ years of experience with regulatory information management tools in a consulting, implementation or support capacity, with exposure to all phases of a regulatory information management tool implementation including requirements gathering, development, deployment and support preferred
• 4+ years of experience managing a team of multiple direct reports, clients and vendors
• Bachelor's degree
• Ability to meet travel requirements: depending on your location and specific project responsibilities, this position may require up to 75% travel (Monday – Thursday).
Professional Skill Requirements
• Proven ability to build, manage and foster a team-oriented environment
• Proven ability to work creatively and analytically in a problem-solving environment
• Desire to work in an information systems environment
• Excellent communication (written and oral) and interpersonal skills
• Excellent leadership and management skills
• Understanding of key Pharmaceutical R&D processes and technologies. Familiarity with industry-standards such as ICH, IDMP, XEVMPD. Experience with the software development lifecycle, specifically in a validated environment.
• Experience owning a defined portion of a project, and a demonstrated ability to manage issues and risks, with an understanding of appropriate and timely escalation.
• Experience managing client and vendor relationships. The ability to identify and articulate the value of new business opportunities.
• Prior supervisory and people development experience.
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Accenture is an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.
Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
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