Regulatory Consultant - Life Sciences

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Role: Life Sciences R&D Regulatory Consulting Manager/Regulatory Business Consultant
 

Accenture’s 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: 

  • 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.

Our R&D business 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.

Job Description

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 Life Sciences R&D Regulatory Consulting Manager/Regulatory Business Consultant will provide consulting services for Regulatory organizations within our Life Sciences portfolio of clients, with particular focus on industry best practices, process innovations and redesign, and implementation of Regulatory technologies to enable these processes. 

The individual in this role is responsible for working directly with Regulatory business and technology clients to: 

  • Assess and improve Regulatory processes and the data flow between Regulatory technology platforms.

  • Assess the current Regulatory technology footprint and support the design and implementation of Regulatory systems to achieve a desired future state.  

  • Design, development and implementation the Regulatory operating models of the future.

  • Transform Regulatory through data driven initiatives (such as IDMP), moving from documents to data and driving automation within Regulatory

Key Responsibilities:

  • Act as a Regulatory subject matter advisor, especially with relation to changing requirements and Health Agency initiatives such as IDMP

  • Contribute to assets/offerings and thought leadership

  • Design best-practice solutions to transform Regulatory functions

  • Enhance Accenture’s marketplace reputation

  • Implement process and change interventions through client delivery of projects

Basic Qualifications:

  • 3+ years of Regulatory experience in either an industry or consulting environment

  • 3+ 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

Preferred Skills:

  • Proven ability to build, manage and foster a team-oriented environment

  • Proven ability to work creatively and analytically in a problem-solving environment

  • Excellent communication (written and oral) and interpersonal skills

  • Excellent leadership and management skills

  • 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. 

  • Some prior supervisory and people development experience.

  • Advanced knowledge of IDMP, CTR and other upcoming Regulatory Agency initiatives

  • Preferably you will possess the right to work and travel freely across Europe as required by the role

Job information

Firm: Accenture

Location: Multiple Locations

Education:

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