Director, Global Regulatory Affairs
TravelNurseSource, Chicago, IL, United States
Is life sciences in your DNA? Breakthroughs in pharma are helping people live healthier lives, while medical devices enable patients to proactively maintain health – this is undoubtedly a transformative time for health care companies. Guidehouse’s Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device, and diagnostic companies develop custom solutions that tackle today’s challenges, while anticipating tomorrow’s. You will have an immediate impact by partnering with our clients, across all levels, to deliver product planning, pricing, reimbursement, product commercialization, and regulatory and compliance solutions. Do you think you are up for the challenge?
What You Will Do The Global Market Access team focuses on value, access, pricing and commercialization strategy projects for pharmaceutical, biotechnology, medical device, and diagnostics companies. Our client services range from pre-commercialization product opportunity assessments to determining and developing launch pricing and access strategies across major and emerging global markets.
Responsibilities
Develop and implement pricing, value, and access strategies for pharmaceutical, biotech, and medical device clients.
Build project proposals and manage consulting teams across large-scale, complex projects to develop and communicate client deliverables, and maintain client relationships.
Lead teams to design, execute, and deliver projects across key value and access topics such as pricing and reimbursement studies (qualitative & quantitative methodologies), early access opportunity assessments, value communication strategy, and payer engagement strategy.
Demonstrate strong market research skills, inclusive of primary qualitative interview and quantitative survey experiences and familiarity with pricing methodologies (e.g., analogue assessment, Van Westerndorp, Gabor Granger, Conjoint, etc).
Understand key access tenets and landscapes across key geographic markets (US, EU, LATAM, APAC).
Leverage work experience, business acumen, and subject matter expertise on global market access topics to determine key approach and develop strategic recommendations that efficiently address client business questions.
Proactively manage own and team members’ time across multiple complex projects.
Liaise with senior staff to ensure strategically sound and actionable insights are developed to answer key client business questions on value, access, and pricing.
Serve as primary point of contact and engage executive-level audience to deliver actionable insights and recommendations.
Build and manage ongoing client relationships as thought partners and elevate new business opportunities through identification of follow-on projects or new opportunities.
Support the development of new analytical methodologies, capabilities, and intellectual property for future engagements.
Develop thought leadership (written or podium) and provide subject matter expertise to clients.
Train and mentor junior team members to enable team development and professional growth.
What You Will Need
Bachelor’s degree in science, biomedical engineering, or healthcare policy and planning.
5-7 years of transferable consulting or work experience with demonstrated experience in value, access, pricing and commercialization strategy projects for large global pharma, mid‑sized pharma and/or biotech clients.
Strong understanding of the pharmaceutical industry, including drug development and launch.
Ability to analyze complex information, identify key issues, and develop effective strategies.
Excellent communication skills to convey strategic recommendations to various stakeholders, including senior management.
2-3 years of direct experience in client management and content delivery roles.
Experience developing, designing and executing value, pricing, and access strategy projects for pharmaceutical, biotech, and medical device companies.
Experience in leadership roles and people development/performance management.
Strong verbal and written communication skills (in English).
Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
Willingness and ability to travel for client work as needed (up to 25%).
Nice to Have
Graduate degree in business or other health-related fields (MBA, MPH, MS, PhD).
Extensive experience as project managers, strong team players, initiative, strategic and creative thinking.
Keen attention to detail.
Superior written and verbal communication skills.
Job Family Strategy & Transformation Consulting
Travel Required Up to 25%
Clearance Required None
Salary The annual salary range for this position is $102,000.00-$170,000.00.
What We Offer Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package reflecting our commitment to creating a diverse and supportive workplace.
Benefits include:
Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Position may be eligible for a discretionary variable incentive bonus
Parental Leave and Adoption Assistance
401(k) Retirement Plan
Basic Life & Supplemental Life
Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
Short-Term & Long-Term Disability
Student Loan PayDown
Tuition Reimbursement, Personal Development & Learning Opportunities
Skills Development & Certifications
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Emergency Back-Up Childcare Program
Mobility Stipend
#J-18808-Ljbffr
What You Will Do The Global Market Access team focuses on value, access, pricing and commercialization strategy projects for pharmaceutical, biotechnology, medical device, and diagnostics companies. Our client services range from pre-commercialization product opportunity assessments to determining and developing launch pricing and access strategies across major and emerging global markets.
Responsibilities
Develop and implement pricing, value, and access strategies for pharmaceutical, biotech, and medical device clients.
Build project proposals and manage consulting teams across large-scale, complex projects to develop and communicate client deliverables, and maintain client relationships.
Lead teams to design, execute, and deliver projects across key value and access topics such as pricing and reimbursement studies (qualitative & quantitative methodologies), early access opportunity assessments, value communication strategy, and payer engagement strategy.
Demonstrate strong market research skills, inclusive of primary qualitative interview and quantitative survey experiences and familiarity with pricing methodologies (e.g., analogue assessment, Van Westerndorp, Gabor Granger, Conjoint, etc).
Understand key access tenets and landscapes across key geographic markets (US, EU, LATAM, APAC).
Leverage work experience, business acumen, and subject matter expertise on global market access topics to determine key approach and develop strategic recommendations that efficiently address client business questions.
Proactively manage own and team members’ time across multiple complex projects.
Liaise with senior staff to ensure strategically sound and actionable insights are developed to answer key client business questions on value, access, and pricing.
Serve as primary point of contact and engage executive-level audience to deliver actionable insights and recommendations.
Build and manage ongoing client relationships as thought partners and elevate new business opportunities through identification of follow-on projects or new opportunities.
Support the development of new analytical methodologies, capabilities, and intellectual property for future engagements.
Develop thought leadership (written or podium) and provide subject matter expertise to clients.
Train and mentor junior team members to enable team development and professional growth.
What You Will Need
Bachelor’s degree in science, biomedical engineering, or healthcare policy and planning.
5-7 years of transferable consulting or work experience with demonstrated experience in value, access, pricing and commercialization strategy projects for large global pharma, mid‑sized pharma and/or biotech clients.
Strong understanding of the pharmaceutical industry, including drug development and launch.
Ability to analyze complex information, identify key issues, and develop effective strategies.
Excellent communication skills to convey strategic recommendations to various stakeholders, including senior management.
2-3 years of direct experience in client management and content delivery roles.
Experience developing, designing and executing value, pricing, and access strategy projects for pharmaceutical, biotech, and medical device companies.
Experience in leadership roles and people development/performance management.
Strong verbal and written communication skills (in English).
Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
Willingness and ability to travel for client work as needed (up to 25%).
Nice to Have
Graduate degree in business or other health-related fields (MBA, MPH, MS, PhD).
Extensive experience as project managers, strong team players, initiative, strategic and creative thinking.
Keen attention to detail.
Superior written and verbal communication skills.
Job Family Strategy & Transformation Consulting
Travel Required Up to 25%
Clearance Required None
Salary The annual salary range for this position is $102,000.00-$170,000.00.
What We Offer Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package reflecting our commitment to creating a diverse and supportive workplace.
Benefits include:
Medical, Rx, Dental & Vision Insurance
Personal and Family Sick Time & Company Paid Holidays
Position may be eligible for a discretionary variable incentive bonus
Parental Leave and Adoption Assistance
401(k) Retirement Plan
Basic Life & Supplemental Life
Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
Short-Term & Long-Term Disability
Student Loan PayDown
Tuition Reimbursement, Personal Development & Learning Opportunities
Skills Development & Certifications
Employee Referral Program
Corporate Sponsored Events & Community Outreach
Emergency Back-Up Childcare Program
Mobility Stipend
#J-18808-Ljbffr