Manager - Advisory Life Sciences - Regulatory Transformation

Company: Deloitte
Location: Costa Mesa
Posted on: June 24, 2022

Job Description:

Manager, Commercial and Regulatory Risk - Life Sciences Advisory

Our Risk and Financial Advisory group is comprised of more than 10,000 partners, managers and staff. We help solve our clients' most complex financial instrument and physical market challenges by delivering risk advisory, technical accounting, quantitative, technology and operational advisory services. Specifically, our consulting projects include risk assessment and solution implementation for business strategies and policies, business processes, organization structure, risk modeling, management reporting and treasury, trading and risk systems. We help clients obtain, analyze and report information from multiple sources and across risk classes to facilitate tactical and strategic decision making.

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 Manager is responsible for managing related consulting projects, in addition to the development and management of staff assigned to projects, a Manager 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
  • 5+ years 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 effectively managing 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 40% 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.

Keywords: Deloitte, Costa Mesa , Manager - Advisory Life Sciences - Regulatory Transformation, Executive , Costa Mesa, California