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Real World Evidence Rwe Jobs in Randallstown, MD

Ambu

Market Access Manager

Columbia, MD · On-site

Collaborate with and support management of the Health Economics team as they lead Ambu's development of real-world evidence and health economics and outcomes research * Manage obtaining additional ...

Towson University

Assistant Teaching Professor

Towson, MD · On-site

$50K - $55K/yr

Cognitive Psychology/Learning Sciences; • show familiarity with ethical, societal, and policy issues related to AI and data science; • evidence of skill in designing authentic, real-world ...

Glenwood Academy

Secondary Math & Science

Eldersburg, MD · On-site

$47K - $63K/yr

Facilitate inquiry-based labs, investigations, modeling tasks, and real-world mathematical ... and evidence-based practices. * Perform other related duties as assigned. Salary The salary for ...

Glenwood Academy

Secondary Math & Science

Sykesville, MD · On-site

$47K - $63K/yr

Facilitate inquiry-based labs, investigations, modeling tasks, and real-world mathematical ... and evidence-based practices. * Perform other related duties as assigned. Salary The salary for ...

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All JobsReal World Evidence Rwe JobsReal World Evidence Rwe Jobs in Randallstown, MD

Real World Evidence Rwe information

What is the difference between Real World Evidence Rwe vs Clinical Data Analyst?

AspectReal World Evidence RweClinical Data Analyst
Required credentialsTypically requires a background in healthcare, epidemiology, or biostatistics, often with a master's or PhDUsually requires a degree in health informatics, biostatistics, or related fields, with similar certifications
Work environmentPrimarily in healthcare, pharmaceutical, or research organizations analyzing real-world dataIn clinical research settings, hospitals, or pharmaceutical companies analyzing clinical trial data
Employer and industry usageUsed by pharma companies, healthcare providers, and research institutions to generate real-world insightsUsed by research organizations, hospitals, and pharma for clinical trial data management and analysis

Real World Evidence Rwe professionals focus on analyzing data from real-world settings like electronic health records and insurance claims, while Clinical Data Analysts primarily work with clinical trial data. Both roles require strong analytical skills and related credentials, but Rwe specialists emphasize real-world data sources to inform healthcare decisions.

What jobs are there in clinical trials?

Jobs in clinical trials include Clinical Research Coordinators, Clinical Data Managers, Clinical Research Associates, and Study Monitors. These roles involve tasks such as patient recruitment, data collection, monitoring trial progress, and ensuring compliance with regulations, often requiring knowledge of Good Clinical Practice (GCP) and relevant certifications. The work environment is typically in hospitals, research centers, or pharmaceutical companies, with schedules varying from standard to flexible hours.

What is RCT and RWE?

In the context of a Real World Evidence (RWE) role, RCTs (Randomized Controlled Trials) are clinical studies that randomly assign participants to different treatments to assess efficacy, while RWE involves analyzing data from real-world settings like electronic health records and insurance claims to evaluate treatment effectiveness outside controlled trials. Both are important for informing healthcare decisions and regulatory approvals, with RWE complementing RCT data by providing insights from everyday clinical practice.

What is Real World Evidence (RWE) in the healthcare industry?

Real World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from analysis of real-world data (RWD). This data is collected from sources outside of traditional clinical trials, such as electronic health records, insurance claims, patient registries, and wearable devices. RWE plays a crucial role in understanding how treatments work in routine clinical practice, informing regulatory decisions, and supporting drug development and market access. Organizations use RWE to complement clinical trial data, improving healthcare outcomes and patient care.

What are the roles in clinical trials?

In clinical trials, roles include Principal Investigator who oversees the study, Study Coordinators who manage daily operations, Data Managers who handle data collection and analysis, and Regulatory Affairs Specialists who ensure compliance with regulations. These roles require specific skills, certifications, and knowledge of Good Clinical Practice (GCP) guidelines to ensure the trial's integrity and participant safety.

What are the key skills and qualifications needed to thrive as a Real World Evidence (RWE) professional, and why are they important?

To thrive as a Real World Evidence (RWE) professional, you need a strong background in epidemiology, biostatistics, and data analysis, often supported by an advanced degree in a relevant scientific field. Familiarity with statistical software (such as SAS, R, or Python), real-world data sources (like EHRs and claims databases), and regulatory guidelines (FDA/EMA) is essential. Strong communication, problem-solving, and cross-functional collaboration skills help convey complex findings to stakeholders and integrate RWE into decision-making. These competencies are crucial for generating credible insights that inform clinical, regulatory, and commercial strategies in the healthcare industry.

How does a Real World Evidence (RWE) professional typically collaborate with cross-functional teams in the pharmaceutical industry?

RWE professionals often work closely with colleagues from epidemiology, health economics, medical affairs, and regulatory affairs to design and execute studies using real-world data. Collaboration is essential, as RWE findings support evidence generation for regulatory submissions, market access, and post-marketing surveillance. Regular meetings, data-sharing sessions, and joint project planning are common, ensuring all stakeholders are aligned on study objectives, methodologies, and data interpretation. This collaborative environment helps translate complex data into actionable insights that support decision-making across the organization.

What is RWE in clinical research?

Real World Evidence (RWE) in clinical research refers to data collected from real-world settings outside controlled clinical trials, such as electronic health records, insurance claims, and patient registries. RWE helps researchers and healthcare professionals understand how treatments perform in routine practice and supports decision-making for drug development and regulatory approval.
What job categories do people searching Real World Evidence Rwe jobs in Randallstown, MD look for? The top searched job categories for Real World Evidence Rwe jobs in Randallstown, MD are:
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Real World Evidence Rwe jobs near you
International Medical Device Countermeasures (MCM) Data SME

International Medical Device Countermeasures (MCM) Data SME

Guidehouse

Silver Spring, MD • On-site

$98K - $163K/yr

Part-time

Medical, Dental, Vision, Life, Retirement

Posted 3 days ago

Guidehouse rating

7.5

Company rating: 7.5 out of 10

Based on 26 frontline employees who took The Breakroom Quiz

48th of 73 rated business consultants

Job description

Job Family:

Scientist


Travel Required:

Up to 10%


Clearance Required:

Ability to Obtain Public Trust

Our client is striving to transform medical device countermeasures (MCM) data management for faster, better-informed regulatory decisions and improved outcomes of future emergencies by relying on its understanding of trusted international regulatory partners and domestic public health entities. This substantial research and development effort requires a subject matter expert (SME) with significant experience in the MCM domain and specializing in data analysis, statistical analysis, data visualization, regulatory science, and international regulatory harmonization and reliance frameworks.

What You Will Do:

  • Lead the research, development and integration of an international reliance framework and establishment of Standards community partnership.

  • Developing a data collection plan and strategy for the devices of interest.

  • Provide insight and guidance in MCM data collection, supporting regulatory science and FDS regulatory roles and processes to support the data model design.

  • Design comparative regulatory analysis of standards utilization and international conformity assessment for devices of interest.

  • Design and direct statistical analyses and development of voluntary consensus standards databases in coordination with program data scientist.

  • Translate evidence based research into a practical international reliance framework, complete with jurisdiction-specific, device-specific, emergency-specific criteria, and cybersecurity considerations.

  • Develop an international reliance framework and criteria; Integrate the final framework into existing protocols and coordination procedures/mechanisms such as the EUA process, IDOC activation, and interagency coordination procedures.

  • translates the evidence base into a practical international reliance framework, complete with jurisdiction-specific, device-specific, emergency-specific criteria, and cybersecurity considerations.

  • Support concept development, requirements analysis, performance metrics, benchmark cases and validation of MCM databases.

  • Characterize Standards Development Organization (SDO) landscape and engagement strategy to support standards alignment and international regulatory reliance MCM; Provide quarterly SDO summary reports and partnership recommendations.

What You Will Need:

  • Master's or PhD in regulatory science, public health, public policy, or related field.

  • Minimum 10 years of experience in medical device regulation

  • Deep expertise in international regulatory harmonization and reliance frameworks.

  • Demonstrated experience with FDA CDRH premarket pathways (510(k), PMA, De Novo, EUA).

  • Knowledge of international regulatory systems (EU MDR, Health Canada, TGA, PMDA, MHRA).

  • Experience with Standards Developing Organizations (e.g. ISO, IEC, GMP, ASTM, etc.).

  • Experience briefing senior leadership and developing policy and guidance documents

  • Strong analytical and writing skills, with experience preparing scientific and leadership presentations.

  • Ability to synthesize complex data from multiple sources into actionable insights.

  • U.S. citizenship or permanent residency (required for federal contract work).

  • Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.

What Would Be Nice To Have:

  • Prior domain experience in MCM public or military health emergency response (e.g., EUA processes, regulatory operations, interagency coordination (e.g. BARDA, CDC) and data exchanges).

  • Experience with post-market surveillance systems, adverse event reporting, and real-world evidence (RWE) datasets.

The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.


What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

  • Medical, Rx, Dental & Vision Insurance

  • Personal and Family Sick Time & Company Paid Holidays

  • Parental Leave

  • 401(k) Retirement Plan

  • Group Term Life and Travel Assistance

  • Voluntary Life and AD&D Insurance

  • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

  • Transit and Parking Commuter Benefits

  • Short-Term & Long-Term Disability

  • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

  • Employee Referral Program

  • Corporate Sponsored Events & Community Outreach

  • Care.com annual membership

  • Employee Assistance Program

  • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

  • Position may be eligible for a discretionary variable incentive bonus

About Guidehouse

Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

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