Life Sciences R&D Regulatory Sr. Consultant

Management Consulting | Strategy & Analytics
Same job available in 7 locations

Position Summary

Life Sciences R&D Regulatory Sr. Consultant


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
  • Content Review and Approval Technologies (e.g., Veeva RIM, PromoMats, DAM, Publishing)
  • Modular Content Governance
  • Emerging Regulatory data standards e.g., IDMP, PQ/ CMC driving compliance and operational efficiencies
  • 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.

 

The team

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.

 

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
  • 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.


Our people and culture

Our diverse, equitable, and inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our client most complex challenges. This makes Deloitte one of the most rewarding places to work. Learn more about our inclusive culture.

Professional development

From entry-level employees to senior leaders, we believe there’s always room to learn. We offer opportunities to build new skills, take on leadership opportunities and connect and grow through mentorship. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career. Learn more about our commitment to developing our people.


As used in this posting, "Deloitte" means Deloitte Consulting LLP, a subsidiary of Deloitte LLP. 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.

We 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, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, where applicable. See notices of various ban-the-box laws where available.

Requisition code: 53487

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