... FDA, EMA guidance). * Market Expertise: Stay current on RWE market dynamics, technology and AI ... Experience managing complex, consultative sales cycles involving scientific, commercial, and data ...
... FDA, EMA guidance). * Market Expertise: Stay current on RWE market dynamics, technology and AI ... Experience managing complex, consultative sales cycles involving scientific, commercial, and data ...
... consultation with works councils and other employee representative bodies, as may berequired ... g., FDA, EU MDR) and internal quality standards. * Drive automation initiatives to improve ...
... consultation with works councils and other employee representative bodies, as may berequired ... g., FDA, EU MDR) and internal quality standards. * Drive automation initiatives to improve ...
Provides the most appropriate blood in a timely and accurate manner and provides phone consultation ... Adheres to all required FDA, AABB (American Association of Blood Banks),CLIA (Clinical Laboratory ...
Provides the most appropriate blood in a timely and accurate manner and provides phone consultation ... Adheres to all required FDA, AABB (American Association of Blood Banks),CLIA (Clinical Laboratory ...
Director, Product Security
Warsaw, IN · On-site
$149K - $183K/yr
... consultation with works councils and other employee representative bodies, as may berequired ... Familiarity with FDA cybersecurity guidance, IEC 62304, ISO 14971, and related standards.
Director, Product Security
Warsaw, IN · On-site
$149K - $183K/yr
... consultation with works councils and other employee representative bodies, as may berequired ... Familiarity with FDA cybersecurity guidance, IEC 62304, ISO 14971, and related standards.
Cardio Partners offers complete cardiac solutions to our customers including equipment, consultation, end-to-end training, and program management. As an authorized master distributer of all FDA ...
Cardio Partners offers complete cardiac solutions to our customers including equipment, consultation, end-to-end training, and program management. As an authorized master distributer of all FDA ...
Provide technical expertise and consultation to laboratory staff, management, and customers ... Ensure compliance with FDA, AABB, CLIA, CAP, OSHA, and cGMP requirements What We're Looking For * A ...
Quick apply
Provide technical expertise and consultation to laboratory staff, management, and customers ... Ensure compliance with FDA, AABB, CLIA, CAP, OSHA, and cGMP requirements What We're Looking For * A ...
Act as a consultant to business partners on digital learning best practices * Provide creative ... Preferred experience in manufacturing or regulated environments (e.g., SQF, FDA) * Preferred ...
Quick apply
Act as a consultant to business partners on digital learning best practices * Provide creative ... Preferred experience in manufacturing or regulated environments (e.g., SQF, FDA) * Preferred ...
Director of Engineering
Taylorsville, IN · On-site
... consultants, and equipment suppliers - Ensure compliance with all food safety, quality ... USDA/FDA sanitary design principles, BRC/ AIB standards, OSHA, GMP's and related regulations ...
Quick apply
Director of Engineering
Taylorsville, IN · On-site
... consultants, and equipment suppliers - Ensure compliance with all food safety, quality ... USDA/FDA sanitary design principles, BRC/ AIB standards, OSHA, GMP's and related regulations ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
In consultation with senior staff, prepare reports, papers and/or charts of study data for interim reports to the sponsor * Maintain knowledge of FDA and other regulatory guidelines that may affect ...
Strong presentation, communication, negotiation, and consultative selling skills. * Ability to ... Knowledge of ASTM, ISO, FDA-regulated, or quality-controlled environments is an asset. * Ability to ...
Strong presentation, communication, negotiation, and consultative selling skills. * Ability to ... Knowledge of ASTM, ISO, FDA-regulated, or quality-controlled environments is an asset. * Ability to ...
Business Development Manager
Shelbyville, IN · On-site +1
... 13485 certification, FDA registration, and Class 8 clean rooms. What You'll Do As Business ... Experience with consultative, conceptual selling - able to deeply understand a customer's business ...
Business Development Manager
Shelbyville, IN · On-site +1
... 13485 certification, FDA registration, and Class 8 clean rooms. What You'll Do As Business ... Experience with consultative, conceptual selling - able to deeply understand a customer's business ...
CQV Senior Project Manager
$120K - $175K/yr
We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical ...
CQV Senior Project Manager
$120K - $175K/yr
We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical ...
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
Quick apply
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
Quick apply
Data Center Commissioning Project Manager
$128K - $150K/yr
We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...
... 13485 certification, FDA registration, and Class 8 clean rooms. What You'll Do As Business ... Experience with consultative, conceptual selling - able to deeply understand a customer's business ...
... 13485 certification, FDA registration, and Class 8 clean rooms. What You'll Do As Business ... Experience with consultative, conceptual selling - able to deeply understand a customer's business ...
CQV Senior Project Manager
$120K - $175K/yr
We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical ...
Quick apply
CQV Senior Project Manager
$120K - $175K/yr
We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical ...
... R consultation, ensuring operational continuity during off-shift hours. This is an off-shift ... Ensure adherence to applicable labor laws, FDA regulations, and GMP requirements through periodic ...
... R consultation, ensuring operational continuity during off-shift hours. This is an off-shift ... Ensure adherence to applicable labor laws, FDA regulations, and GMP requirements through periodic ...
Fda Consulting information
See Indiana salary details
$22.66 is the 25th percentile. Wages below this are outliers.
$18.07 - $23.37
29% of jobs
$23.37 - $28.68
0% of jobs
$28.68 - $33.98
0% of jobs
$33.98 - $39.28
0% of jobs
$39.28 - $44.58
0% of jobs
$44.58 - $49.89
19% of jobs
The median wage is $51.21 / hr.
$49.89 - $55.19
10% of jobs
$55.19 - $60.49
3% of jobs
$64.78 is the 75th percentile. Wages above this are outliers.
$60.49 - $65.79
18% of jobs
$65.79 - $71.10
9% of jobs
$71.10 - $76.40
12% of jobs
$18
$49
$76
How much do fda consulting jobs pay per hour?
What is an FDA consulting?
An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.
What skills and qualifications are needed for FDA consulting?
To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.
What does an FDA consultant do?
As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

Datavant rating
7.1
Based on 103 frontline employees who took The Breakroom Quiz
148th of 223 rated it services
Job description
Datavant is the data collaboration platform trusted for healthcare. Guided by our mission to make the world's health data secure, accessible and actionable, we provide critical data solutions for organizations across the healthcare ecosystem - including providers, health plans, researchers, and life sciences companies. From fulfilling a single patient's request for their medical records to powering the AI revolution in healthcare, Datavanters are building the future of how data is connected and used to improve health.
By joining Datavant today, you're stepping onto a driven and highly collaborative team that is passionate about creating transformative change in healthcare.
Objective of the Role
The Client Partner, Real-World Evidence is responsible for driving growth with biopharma customers by leveraging Datavant's portfolio of real-world evidence (RWE) solutions, analytics platforms, and AI platform and services. This role will partner closely with Client Partners across key accounts for co-selling, account planning, and evidence strategy alignment.
You will serve as a trusted advisor on the use of real-world data (RWD) and RWE to support regulatory, market access, and HEOR needs - representing the voice of the customer and ensuring that Datavant's offerings meet evolving evidence generation requirements. The ideal candidate is comfortable leading complex, multi-stakeholder sales cycles and brings deep expertise in real-world data, evidence platforms, and outcomes research.
Responsibilities of the Role
-
Prospect & Generate Leads: Develop and execute strategic plans to identify and target new business opportunities in biopharma, healthcare, and life sciences with a focus on organizations investing in real-world evidence strategies for regulatory submissions, market access, and clinical development.
-
Build Pipeline: Proactively engage prospects via outbound calls, emails, and industry networking to build a robust pipeline of opportunities related to Aetion's evidence generation, AI, and analytics solutions.
-
Close Deals: Own the full sales process - from initial outreach to contract closure - ensuring alignment between customer evidence needs and Aetion's RWE offerings, including the Aetion Evidence Platform (AEP) and associated data and consulting services.
-
Client Engagement: Present Aetion's value proposition in RWE and RWD analytics through compelling demonstrations and business cases that highlight regulatory-grade evidence generation, comparative effectiveness, and real-world outcomes research. Engage with senior stakeholders including heads of HEOR, RWE, Market Access, and Clinical Development.
-
Collaborate Cross-Functionally: Partner with marketing, product, and science teams to deliver tailored RWE solution proposals, ensuring alignment with client data strategies, evidence frameworks, and regulatory expectations (e.g., FDA, EMA guidance).
-
Market Expertise: Stay current on RWE market dynamics, technology and AI, regulatory guidance for real-world data, and competitor offerings to position Aetion as a strategic leader and partner of choice in the evidence generation ecosystem.
-
Forecasting & Reporting: Maintain accurate pipeline management and forecasting in CRM systems, with attention to evidence project cycles, platform usage models, and customer expansion opportunities.
-
Drive Growth: Identify new and upsell opportunities across assigned territories and existing accounts, particularly in expanding RWE adoption for post-approval studies, safety monitoring, and market access support.
Qualifications of the Role
-
Proven Track Record: 6+ years of successful sales experience, ideally in healthcare, life sciences, or SaaS; with a strong preference for experience selling RWE, HEOR, or data analytics solutions. Background in selling AI is also to be considered.
-
RWE Expertise: Deep understanding of real-world data sources, evidence generation methodologies, and use cases across the product lifecycle - from clinical development to commercialization.
-
Hunter Mentality: Skilled at identifying, developing, and closing new RWE-focused opportunities with top biopharma clients.
-
Sales Expertise: Experience managing complex, consultative sales cycles involving scientific, commercial, and data stakeholders.
-
Technology/AI Skill Sets: Proven experience, knowledge, and market understanding on real AI-driven use cases for HEOR and RWE.
-
Presentation Skills: Exceptional ability to communicate scientific and technical value propositions to diverse audiences, including C-suite and RWE/HEOR leadership.
-
CRM Proficiency: Experienced in CRM management for tracking RWE opportunity pipelines and forecasting revenue growth.
-
Industry Knowledge: In-depth knowledge of RWE market trends, regulatory guidance, and payer evidence needs is essential.
-
Collaborative Team Player: Comfortable working with cross-functional science, data, and product teams in a fast-paced, mission-driven environment.
-
Communication Skills: Strong written and verbal communication skills, capable of translating complex RWE concepts into impactful narratives for decision-makers.
#BC-LI1
We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services.
The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation.
The estimated base salary range (not including variable pay) for this role is:
$140,000-$170,000 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here (https://www.datavant.com/eeo-commitment-statement) . Know Your Rights (https://www.eeoc.gov/know-your-rights-workplace-discrimination-illegal) , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, (https://peopleteam.datavant.com/portal/en/newticket?departmentId=248697000248790029&layoutId=248697000248795462) by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here (https://app.tango.us/app/workflow/Greenhouse--Locating-Requisition-ID-2c7d618c8a8a423da4330ff12330695e) . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
For more information about how we collect and use your data, please review our Privacy Policy (https://www.datavant.com/privacy-policy) .
About Datavant
Sourced by ZipRecruiter
Industry
Software development
Company size
51 - 200 Employees
Headquarters location
San Francisco, CA, US
Year founded
2017