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
End-to-end Regulatory Information Management (RIM) Process
Emerging Regulatory data standards e.g., IDMP, PQ/ CMC driving compliance and operational efficiencies
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.
S&A Strategic Growth Transformation Team
We help clients architect strategies and transformation programs for growth and value creation through levers such as strategic dialogue facilitation, innovation, portfolio optimization, differentiation and business model transformation.
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
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.
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. At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits.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. 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. We want job seekers exploring opportunities at Deloitte to feel prepared and confident. To help you with your interview, we suggest that you do your research: know some background about the organization and the business area you’re applying to.