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Deloitte LIfe Sciences Healthcare Compliance and Operational Risk Manager in San Jose, California

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

  • Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.

How you’ll grow

At Deloitte, our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to help sharpen skills in addition to hands-on experience in the global, fast-changing business world. From on-the-job learning experiences to formal development programs at Deloitte University, our professionals have a variety of opportunities to continue to grow throughout their career. Explore Deloitte University, The Leadership Center. (https://zoomforth.com/s/deloitte/du#home)

Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you. (http://www2.deloitte.com/us/en/pages/careers/articles/life-at-deloitte-benefits-and-rewards.html)

Deloitte’s culture

Our positive and supportive culture encourages our people to do their best work every day. We celebrate individuals by recognizing their uniqueness and offering them the flexibility to make daily choices that can help them to be healthy, centered, confident, and aware. We offer well-being programs and are continuously looking for new ways to maintain a culture where our people excel and lead healthy, happy lives. Learn more about Life at Deloitte. (http://www2.deloitte.com/us/en/careers/life-at-deloitte.html?icid=top_life-at-deloitte)

Corporate citizenship

Deloitte is led by a purpose: to make an impact that matters. This purpose defines who we are and extends to relationships with our clients, our people and our communities. We believe that business has the power to inspire and transform. We focus on education, giving, skill-based volunteerism, and leadership to help drive positive social impact in our communities. Learn more about Deloitte’s impact on the world. (http://www2.deloitte.com/us/en/pages/about-deloitte/articles/deloitte-corporate-citizenship.html)

Recruiter tips

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Category: Risk Management

About Deloitte

As used in this document, Deloitte means Deloitte LLP and its subsidiaries. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. 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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