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Job Details

Advisory - Senior Consultant - Life Sciences - Regulatory Transformation

Location
San Jose, CA, United States

Posted on
Jun 19, 2022

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Job Information
Deloitte
Advisory - Senior Consultant - Life Sciences - Regulatory Transformation
in
San Jose
California
Our professionals guide traditional life science companies and new market entrants in navigating the complexities of the US and global health care system, especially as it relates to the interactions our clients have with external healthcare professionals, patients, payers and third parties. As market, political, and legislative changes alter the industry, we help our clients develop innovative and practical solutions to mitigate compliance risks. Specifically, our consulting projects include compliance risk assessments, the development and implementation of compliance reviews and monitoring programs, and the identification and implementation of digital solutions for more efficient operations and/or improved decision making through analytics.
Regulatory & Operational Risk
Businesses today face complex regulations and often volatile operating environments. Turn the tide to protect and create value and evolve regulations into opportunity. Learn to lead, navigate, and disrupt to accelerate performance through effective management of regulatory and operational risks.
Life Sciences & Health Care
Our professionals guide traditional life sciences and health care companies and new market entrants in navigating the complexities of the US and global health care system. As market, political, and legislative changes alter the industry, we help our clients develop innovative and practical solutions.
Work You'll Do
The Senior Consultant is responsible for helping to deliver and lead related client projects, and in doing so to continue to grow professionally in the areas of subject matter expertise and consulting engagement administration. A Senior Consultant must understand how Commercial and Medical activities and related messaging/content are influenced by Regulatory/Health Authority requirements. This could include:
Commercial and/or Medical Content Management
Medical, Legal, Regulatory Review Processes
Content Review and Approval Technologies (e.g., Veeva PromoMats, DAM, Publishing)
Modular Content Governance
Labeling Management
Project Management for Global, Transformative Programs
We are seeking an individual either with consulting experience or with experience working in a related function at a Pharmaceutical, Biotech and/or Medical Device manufacturer who can make a successful transition to a consulting environment.
Qualifications
Bachelor's degree required
3 years of experience in the Pharmaceutical, Biotech and/or Medical Device industries strongly preferred
Must understand the role that regulatory agencies (FME, EMA, etc.) play in the product development and commercial areas
Must have knowledge and experience regarding the regulations associated with Commercial and Medical activities and related content development and review & approval processes
Must understand the end-to-end content lifecycle and capabilities/enablers required to increase the speed at which content is development and reviewed & approved
Knowledge of regulatory and compliance aspects of business processes across Life Science broadly, to define and implement strategy, design / re-design processes and support technology
Experience in Project Management
Experience working in a mandated deadline environment and ability to work effectively on multiple client assignments
Additional expectation is to continually build detailed subject matter expertise and assist in build out the service offerings in the area of Commercial and Medical Content Management
High accuracy rate and attention to detail; ability to produce client-ready deliverables to a high-level executive/professional client base
Experience leading/mentoring a cross functional team of government program consultants
Ability to travel up to 50%, on average, based on the work you do and the clients and industries/sectors you serve
Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status, or any other legally protected basis, in accordance with applicable law.

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