Manager, Regulatory Safety - Pharma
Risk and Financial Advisory Overview:
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 health care and life science 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 be a Subject Matter Expert (SME) within either Regulatory and/or Quality and/or Patient Safety. This could include:
- Regulatory Strategy, Transformation and Operations
- Regulatory Intelligence
- Pharmacovigilance (incl. ICSR, Signal Detection and Management etc.)
- Medical Technology LifeCycle Management
- Quality Management Transformation
- 3 rd Party Risk
The Manager is responsible for managing projects including but not limited to:
- Developing and assessing the policies, procedures and systems which support the submission of pricing information to federal and state agencies.
- Assisting with development and evaluation of contract options for Commercial and Government payers.
- Evaluating contract proposals and analyses and performing impact analysis on government pricing and gross to net revenue
- Performing Government Pricing recalculations and restatement projects
- Implementing Commercial Software solutions
The Manager is a SME that other Deloitte team members may query and receive advice and guidance with questions in their area of expertise. Travel to client sites will also be required. We are seeking an individual either with consulting experience or with experience working in a related function at a pharmaceutical or medtech manufacturer who can make a successful transition to a consulting environment. The Team
As the regulatory landscape continues to shift and grow in complexity, companies are facing unprecedented compliance challenges and close regulatory scrutiny. We provide solutions in health care compliance, risk and technology-driven managed services. Managing your financial, operational, and reputational risk to allow you to focus on what matters most - the patient, innovation, and the greater health care marketplace. Qualifications
- Bachelor's degree required in finance, accounting or other applicable business experience.
- 8+ years in Pharmaceutical industry (within industry or a consulting firm)
- Experience in consulting for Pharmaceutical, Biotech and/or Medical Device industries strongly preferred
- Must have knowledge and experience regarding US FDA, EMA and Japanese Safety and Quality Regulations for pharmaceuticals, medical devices and consumer health products
- Knowledge of regulatory and compliance aspects of business processes across Life Science, to define and implement strategy, design / re-design process and support technology
- Must have experience with Pharmacovigilance / Drug Safety.
- Experience performing data assessments.
- Experience in Project Management
- Experienced working in mandated deadline environment; effective in managing multiple client assignments; ability to prioritize.
- Additional expectation is to continually build detailed subject matter expertise and assist in build out of service offerings in area of Regulatory Safety
- 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
How you'll grow
- Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future.
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. 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. 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. 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. Recruiter tips
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. Check out recruiting tips from Deloitte professionals.
As used in this posting, "Deloitte Advisory" means Deloitte & Touche LLP, which provides audit and enterprise risk services; Deloitte Financial Advisory Services LLP, which provides forensic, dispute, and other consulting services; and its affiliate, Deloitte Transactions and Business Analytics LLP, which provides a wide range of advisory and analytics services. Deloitte Transactions and Business Analytics LLP is not a certified public accounting firm. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. These entities are separate subsidiaries of Deloitte LLP.
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.
Deloitte will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws. See notices of various ban-the-box laws where available. https://www2.deloitte.com/us/en/pages/careers/articles/ban-the-box-notices.html
Requisition code: E20NATFMGRCP027-ROR