Our Culture

Fairness, respect and inclusion sit at the core of our name. Our people are our greatest asset, so we are continually investing in our people, process improvement and technology to deliver the very best to our customers. As an organization, we are committed to inclusion, we own our limitations, and we value new and different ideas.

Eight Signs of a Strong Company Culture

Diversity & Inclusion

Meitheal is passionate about inspiring and maintaining diversity and inclusion in the workplace. Companies that embrace people for their talents and character regardless of age, gender identity, race, sexual orientation, physical or mental ability, ethnicity, and perspective are simply better places of business.

More important, creating an environment where everyone from any background can do their best work isn’t just the right thing to do: It is the smart thing to do.

Equal Opportunity

Meitheal provides equal opportunity employment to all employees and applicants for employment.

We further prohibit discrimination and harassment of any type at work without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Our equal opportunity employment policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Community Meitheal

What do today’s employees really look for in a company, and what are the best ways a business gives back? At Meitheal, those are questions we think about often – and strive to answer in the most meaningful ways.

We understand that today’s dedicated professionals in generics, specialty biopharma and fertility desire qualities such as a good match of skills and position; opportunities to further learn and develop; an inspiring, progressive environment; and a culture of inclusion and diversity.

They also truly want to be a part of something greater – something that gives back and sustains. Meitheal shows its commitment to the community through various employee volunteer opportunities, fundraising, and partnerships with local non-profits.

Just a few of our specific community efforts include:

  • Tutors and board members of Tutoring Chicago, which tutors children of the city and Chicago Public Schools
  • Donors and volunteers for the Greater Chicago Food Bank and the Lakeview Pantry
  • Salvation Army Christmas Giving Tree, providing Christmas presents for children in foster care
  • Feed My Starving Children, packing and shipping meals for developing countries
  • Rosemont Operation North Pole, providing a Christmas experience for terminally ill children who are health-compromised and their families
  • Active partnerships with the Direct Relief Agency, donating our drug products throughout the year during times of crisis or need

Our Benefits

We strive to offer a robust benefits program that meets the needs of each of our team members.
Just a few of the many benefits we offer include:

Benefit icon

Extensive Health
Offerings Including
Medical, Dental, Vision

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Paid Time Off (PTO)

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Company Paid
Holidays

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Onsite Gym
Membership

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401K Retirement
Savings Plan

Benefit icon

Annual
Performance-Bonus
Opportunity

Benefit icon

Short- and Long-Term Disability

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Paid Parental
Leave

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Employee Wellness
Resources

Benefit icon

Flexible Work
Arrangements

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Competitive
Wages

Benefit icon

Life and AD&D
Insurance

Have questions?

Contact us

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Careers

We love to empower the careers of those who are committed, curious, collaborative, and courageous.

At Meitheal, we are united by our mission to provide easy access to fairly priced products. Meaningful work creates a meaningful career. With this, we provide the opportunity to not only improve the quality of life for patients, but for you to grow professionally as well. We embrace the diversity of our employee culture and the contributions that come from this.

By providing insightful guidance and fostering an environment of empowerment and collaboration, we celebrate our successes together. Our award-winning culture and exceptional team give us much to be proud of.

We are growing rapidly, so check back often!

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

The Account Representative will be responsible for consistently meeting and exceeding territory sales and performance objectives. The objectives include financial and performance measures that are met through a solution-oriented and collaborative sales approach. The Account Representative’s must have success in Branded Antibiotic sales and Hospital Formulary process. 


Compensation range for this position is $99,500 to $128,600. Payrate is determined by considering a person's prior experience and competence. 


Why Work with Us?

· Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

· Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

· Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

  • Develop outstanding product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients.
  • Function independently, with a high degree of sales proficiency, to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed therapeutic and territory expectations. 
  • Develop, execute, and monitor territory and business plans; strategically and consistently targeting key stakeholders within each account to expand product usage and customer base.
  • Proactively identify business opportunities and present value propositions aligned to customer needs and objectives.
  • Advance hospital and customers along the sales continuum and gain prescriber commitments through effective questioning, active listening, and utilizing approved marketing and sales materials.
  • Demonstrate knowledge of promoted product(s), competitive brands and disease state, patient profiles, and treatment pathways.
  • Achieve success in a complex, matrixed selling environment in which the need for collaboration and cross-functional discipline is critical. Cross-functional partners may consist of Market Access, Medical, Marketing and Operations colleagues.
  • Develop and execute pull-through strategies that increase adoption and usage of Meitheal products in appropriate patients.
  • Use data tools and insights, and other informational sources, to determine strategies and tactics for business decision-making.
  • Utilize CRM technology in an accurate and timely manner to report activities and account level details. 
  • Distribute samples and record sample transactions in accordance with Company Policy and PDMA guidelines.
  • Ensure compliance with all company policies, procedures, principles, values, and applicable laws.
  • Manage appropriate utilization and distribution of resources including territory budgets, Speaker Programs allocations, samples, etc.
  • Comply with all company training requirements, learning modules, required acknowledgements (IC plans, Compliance, etc.).
  • Complete all training and administrative duties, successfully and on time. This includes, but is not limited to accurate and complete call reporting, expense report management, time off management in ADP, etc.


Qualifications

  • Bachelor’s Degree, or equivalent combination of skills and experience required.
  • 5+ years of pharmaceutical sales experience with a minimum of 3+ years of sales experience within the hospital setting, ideally with anti-infectives.
  • Antibiotic account management experience is strongly preferred, or clinical (e.g., nurse, pharmacist) o.k. too.
  • Documented and measurable track record of sales performance which includes meeting or exceeding territory performance goals.
  • Account-based selling experience, within territory assigned, required.
  • Experience calling on urologists and other healthcare practitioners who treat urinary tract infections.
  • Experience building advocacy in a hospital (with or without a formulary win) for an anti-infective product.
  • Proven ability to understand, articulate and routinely present complex scientific information.
  • Strong presentation, organization, administrative and communication skills.
  • Experience in utilizing and optimizing CRM systems in support of territory dynamics. 
  • Prior experience promoting newly launched products.
  • Safe driving record and valid driver’s license required.
  • Demonstrated experience and mastery in delivering a total office call.
  • Demonstrated effective time management, organizational and communication skills to prioritize opportunities and execute flawlessly.
  • Demonstrated judgment and decision-making capability.


Computer Skills

Microsoft Office, CRM Experience

Physical Demands

Travel

Travel requirements: The average overnight travel for this position is up to 30% with some variation based upon the time of year and demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Essential Duties and Responsibilities

  • Effectively generate product demand by educating and engaging customers through the promotion of the Generics pharmaceutical portfolio.
  • Proactively identify business opportunities and present value propositions aligned to customer needs and objectives.
  • Establish and deepen relationships with key decision makers and influencers within assigned organizations.
  • Function independently, with a high degree of sales proficiency, to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed territory expectations.
  • Identify and drive opportunities with assigned customers, and develop strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements.
  • Develop and execute product pull-through strategies that increase adoption and usage of Meitheal products.
  • Develop, execute, and monitor territory and business plans; strategically and consistently targeting key stakeholders within each account to expand product usage and customer base.
  • Conduct customer calls and meetings to drive contract compliance, discover unmet opportunities and position the Company’s future products.
  • Advance customers along the sales continuum and gain product usage commitment through effective questioning, active listening, contract negotiation, objection handling, and utilizing approved marketing and sales materials.

·        Provide market intelligence to internal teams as received, and as requested.

  • Achieve success in a matrixed selling environment in which the need for collaboration and cross-functional discipline is critical. Cross-functional partners may consist of National Accounts, Marketing, Contract Marketing, Commercial Analytics, and Operations colleagues.
  • Use data tools and insights, and other informational sources, to determine strategies and tactics for business decision-making.
  • Utilize CRM technology in an accurate and timely manner to report activities, account level details, and pipeline opportunity management.
  • Ensure compliance with all company policies, procedures, principles, values, and applicable laws.
  • Comply with all company training requirements, learning modules, required acknowledgements (IC plans, Compliance, etc.).
  • Complete all training and administrative duties, successfully and on time. This includes, but is not limited to: accurate and complete call reporting, expense report management, time off management, etc.
  • Travel as required, to support customer and commercial team meetings.
  • Other duties may be assigned.


Competencies

  • Business Acumen
  • Communication Skills
  • Analytical Skills
  • Negotiation Skills
  • Critical Thinking Skills

Qualifications

  • Bachelor’s Degree, or equivalent combination of skills and experience required.
  • 2+ years of pharmaceutical sales experience with a minimum of 1+ year of sales experience within the acute hospital setting. Prior experience working with major IDNs and Regional Key Customers preferred.
  • Knowledge of Generic injectable drugs and prior experience promoting newly launched products.
  • Measurable track record of sales performance which includes meeting or exceeding territory performance goals.
  • Account-based selling experience, within assigned territory.
  • Strong presentation, organization, contract negotiation, administrative and communication skills.
  • Experience in utilizing and optimizing CRM systems in support of territory dynamics.
  • Demonstrated experience delivering virtual customer engagement meetings, routinely promoting and presenting product promotional materials and customer data analytics.
  • Demonstrated effective time management, organizational and communication skills to prioritize opportunities and execute flawlessly.
  • Demonstrated judgment and decision-making capability.


Computer Skills

Microsoft Office, CRM Experience, Tableau

Physical Demands

Travel

·        Some travel may be required with some variation based upon the time of year and   demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.

Work Environment

This is a field-based role.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.



Position Summary:

The Account Manager - Generic Pharmaceuticals will be responsible for consistently meeting and exceeding territory sales and performance targets for the Generics pharmaceutical portfolio through virtual customer interactions that include Integrated Delivery Networks (IDNs) and regional key customer(s) in acute hospital, and acute, non-hospital facilities. This role reports to the Director of Sales and Commercial Effectiveness and will work closely with National Accounts, Marketing, Contracting, and other internal departments to meet agreed upon goals and objectives. This is a remote, field-based sales position with some travel as required.


Account Manager, South Central covers the following states: AL, AR, IA, MO, MS, NE, OK, TX


Payrate is determined by considering a person's prior experience and competence. 

Essential Duties and Responsibilities

  • Effectively generate product demand by educating and engaging customers through the promotion of the Generics pharmaceutical portfolio.
  • Proactively identify business opportunities and present value propositions aligned to customer needs and objectives.
  • Establish and deepen relationships with key decision makers and influencers within assigned organizations.
  • Function independently, with a high degree of sales proficiency, to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed territory expectations.
  • Identify and drive opportunities with assigned customers, and develop strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements.
  • Develop and execute product pull-through strategies that increase adoption and usage of Meitheal products.
  • Develop, execute, and monitor territory and business plans; strategically and consistently targeting key stakeholders within each account to expand product usage and customer base.
  • Conduct customer calls and meetings to drive contract compliance, discover unmet opportunities and position the Company’s future products.
  • Advance customers along the sales continuum and gain product usage commitment through effective questioning, active listening, contract negotiation, objection handling, and utilizing approved marketing and sales materials.

·        Provide market intelligence to internal teams as received, and as requested.

  • Achieve success in a matrixed selling environment in which the need for collaboration and cross-functional discipline is critical. Cross-functional partners may consist of National Accounts, Marketing, Contract Marketing, Commercial Analytics, and Operations colleagues.
  • Use data tools and insights, and other informational sources, to determine strategies and tactics for business decision-making.
  • Utilize CRM technology in an accurate and timely manner to report activities, account level details, and pipeline opportunity management.
  • Ensure compliance with all company policies, procedures, principles, values, and applicable laws.
  • Comply with all company training requirements, learning modules, required acknowledgements (IC plans, Compliance, etc.).
  • Complete all training and administrative duties, successfully and on time. This includes, but is not limited to: accurate and complete call reporting, expense report management, time off management, etc.
  • Travel as required, to support customer and commercial team meetings.
  • Other duties may be assigned.


Competencies

  • Business Acumen
  • Communication Skills
  • Analytical Skills
  • Negotiation Skills
  • Critical Thinking Skills

Qualifications

  • Bachelor’s Degree, or equivalent combination of skills and experience required.
  • 2+ years of pharmaceutical sales experience with a minimum of 1+ year of sales experience within the acute hospital setting. Prior experience working with major IDNs and Regional Key Customers preferred.
  • Knowledge of Generic injectable drugs and prior experience promoting newly launched products.
  • Measurable track record of sales performance which includes meeting or exceeding territory performance goals.
  • Account-based selling experience, within assigned territory.
  • Strong presentation, organization, contract negotiation, administrative and communication skills.
  • Experience in utilizing and optimizing CRM systems in support of territory dynamics.
  • Demonstrated experience delivering virtual customer engagement meetings, routinely promoting and presenting product promotional materials and customer data analytics.
  • Demonstrated effective time management, organizational and communication skills to prioritize opportunities and execute flawlessly.
  • Demonstrated judgment and decision-making capability.


Computer Skills

Microsoft Office, CRM Experience, Tableau

Physical Demands

Travel

·        Some travel may be required with some variation based upon the time of year and   demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.

 

Work Environment

This is a field-based role.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

Associate Director of Regulatory Affairs, Biopharma, will be responsible for providing regulatory guidance to (Bio)Pharma product development and tech transfer, especially biosimilars, preparing and reviewing meeting packages and submissions. S/he will work closely with cross-functional teams within the Company and across business partners, including development, regulatory, clinical and quality, as well as the senior leadership team, to develop regulatory strategies for both projects and portfolios in BioPharma, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth towards biopharmaceuticals.


Compensation range for this position is $150,000 to $174,000. Payrate is determined by considering a person's prior experience and competence. 


Why Work with Us?


  • Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
  • Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
  • Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
  • Professional Growth: We offer ample opportunities for professional development and career advancement.



Essential Duties and Responsibilities

  • Understand US regulatory guidance on biologics/biosimilars, track and interpret new guidance & new requirements for biosimilars, and assess their impact on the product development, including expertise, timeline and budgeting.
  • Represent the regulatory function on cross-functional developmental teams for biosimilars, primarily with the Operations, Quality, Legal and Marketing teams. 
  • Prepare, review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc. 
  • Serve as an interface with other regulatory groups in development, clinical partners, and consulting services.
  • Lead preparation and management of meetings with health authorities, such as US FDA, EMA 
  • Contribute to launch readiness and marketing by guiding the project team on the most appropriate regulatory approach, from development through approval, and provide post-market support. 
  • Provide due diligence and review documents from global business partners for technical and regulatory compliance.
  • Work with the Head of Regulatory Affairs department to build up the competence and capacity for biosimilar and biologics.
  • Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross-functions.  Provide support to CMC and regulatory sciences of complex generics, especially peptide generics, as well as combination products


Supervisory Responsibilities

No direct report.

Competencies

  • Planning and Organizing
  • Teamwork
  • Problem Solving
  • Quality
  • Judgment
  • Dependability
  • Strong Interpersonal Skills


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Education and/or Experience 

Bachelor, Master, or Ph.D. 's degree in life sciences; over 8 years related experience in product development and/or regulatory CMC, with minimum of 3 years in biologics and/or biosimilars, or equivalent combination of skills and experience.


Preferred 

Expertise in and experience with Regulatory Affairs of biosimilars or biologics is highly preferred.


Language Skills 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.


Mathematical Skills 

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.


Reasoning Ability 

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.


Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), etc.

Physical Demands

Occasional travel expected (<10%)

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Meitheal Pharmaceuticals


Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits

 

Job Summary

 

The Computer Software Assurance Analyst is responsible for Computer Software Validation and Assurance activities for Meitheal’s GMP Computer Systems. This individual will be responsible for developing, updating and executing Software Lifecycle documents [Validation Plan, Qualification Protocols/Test Scripts, Risk Assessments, Validation Reports, Procedures, etc.] in accordance with their specified requirements and validated in accordance with FDA and other agency requirements.


Compensation range for this position is $71,000 to $90,000. Payrate is determined by considering a person's prior experience and competence. 


Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.


  • Author/Update Computer System Validation deliverables, including Validation Plans, User Requirements Specifications, Functional Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's and Change Control Documentation.
  • Review of vendor provided validation documentation to determine suitability and alignment with company CSV SOPs and GAMP5.
  • Support the release updates for all GMP related computer systems.
  • Thorough knowledge of 21 CFR Part 11 (210, 211, 600, and 820), Data Integrity, GAMP5 requirements and FDA industry regulations.
  • Collaborate with the Process Owners SMEs to determine, and document, appropriate user requirements
  • Apply FDA's new CSA guidelines to leverage risk-based strategy for testing to reduce documentation burdens while maintaining product quality and safety.
  • Participate in the development, implementation, and modification of Computer System Validation Standard Operating Procedures (SOP) based on current regulations and industry standards.
  • Work with QA to resolve any discrepancies or issues encountered during the validation of a computer system.

·        Support QA in periodic audits and inspections, ensuring that all validation documentation is audit ready.

Competencies

  • Code of Federal Regulations and cGMP’s relating to the field of Computer System Validation.
  • Ability to write technical documents (like Validation Plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report, etc.).
  • Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization.
  • Ability to establish clear priorities quickly, work effectively under pressure, handle multiple projects and meet deadlines
  • Ability to quickly learn and understand multiple types of software programs and/or SaaS applications including but not limited to QMS, ERP, Serialization, eCTD, Software Testing Tools ValGenesis) etc.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Assimilate to changing environments.
  • Ability to prioritize and multitask.
  • Organized and detailed orientated. 
  • Have a sense of urgency to meet all required deadlines

Education and/or Experience Required

  • Degree (Bachelor’s or Masters) in Computer Science, Software Engineering or other relevant Science Field or equivalent relevant experience.
  • Two (2) to three (3) years in a cGMP-related industry with Computer System Validation and 21 CFR Part 11 compliance.
  • Previous experience in writing, reviewing and executing computer validation documentation (VP, IQ, OQ, PQ, VSR).
  • Knowledge of cGMP, GDP, GAMP, 21CFR Part 11, Data Integrity and industry best practices.
  • Ability to understand existing and new business processes and requirements, to ensure proper implementation and validation of systems.
  • Experience with SaaS systems in GxP environment preferred.
  • ASQ, ISTQB Certification relevant to Software Quality Assurance is a plus. 


Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), TrackWise/TrackWise Digital, SAP, Docubridge, Software Testing Tools

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit. The employee is occasionally required to stand; walk and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

The Director of Product Management for Meitheal's Critical Care and Anesthesia portfolio plays an instrumental role in providing leadership to ensure the product portfolio is properly positioned and developed to drive both short and long-term financial success. This role will focus on portfolio positioning, oversight of new product launch activities, participation in annual budget/forecasting process, monthly S&OP cycle and providing product support to various other internal functions.


Compensation range for this position is $153,700 to $225,000. Payrate is determined by considering a person's prior experience and competence. 

Essential Duties and Responsibilities

  • Lead the development of product portfolio plans and strategic initiative to meet organization financial targets, overcome business challenges and drive attainment of market share.
  • Oversee the development of product promotional strategies, partnering with internal and external stakeholders.
  • Work collaboratively with the Market Intelligence, Pricing Analytics, Sales, Contract Marketing and other departments to meet overall product portfolio goals.
  • Provide pricing recommendations and insights to support maximization of product sales and gross profit optimization.
  • Responsible for providing both volume and market share goals as part of Meitheal’s annual budget and forecasting process. 
  • Provide monthly updates as to status of meeting target volume goals and provide recommendations to either further accelerate success or opportunities to overcome volume challenges.
  • Lead review and submission of forecast changes and drivers thereof for monthly S&OP cycle.
  • Lead development and execution of go-to-market strategy for assigned new product launches including customer targeting using awareness of GPO/Trade/IDN landscape, pricing strategy and competitive landscape, working cross-functionally to ensure all aspects of product launches are on track to meet product introduction targets.
  • Utilizing multiple inputs provided throughout the organization, serve as the portfolio expert as it relates to product positioning, competitive information, channel penetration and product performance.
  • Lead the development, education and maintenance of product tools (brochures, website, sales collateral, etc.)


Supervisory Responsibilities

Supervisory responsibilities including one or more direct reports.

Competencies

Business Acumen

· Judgement

· Change Management

· Project Management

· Ethics

· Interpersonal

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. 


• Bachelor’s Degree in a business-related discipline with at least seven years of increasing responsibility and experience in generic pharmaceutical industry, with preference towards product management, portfolio management or marketing. 

• Awareness of GPO/Trade/IDN landscape and knowledge.

• Ability to understand, translate and integrate multiple data sources into clear and impactful insights to drive decision making.

• High level of business acumen, analysis and judgement.

• Strategy development, project management, and problem-solving skills.

• Exceptional interpersonal communication skills.

• Ability to build positive working relationships, both internally and externally.


Preferred

• Advanced degree (MBA/MS)

• Experience with global operating structures

Computer Skills

Extensive computer proficiency with desktop software in a Windows environment required: Microsoft Word; Excel; PowerPoint required. 

Work Environment

Why Join Us?


  • Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
  • Work in a collaborative and supportive environment that values teamwork and common goals.
  • Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
  • Hybrid schedule – two days in the office per week.
  • Casual dress code.


AAP/EEO Statement

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

  

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

The Legal Counsel – Branded and Biologic Products is responsible for providing comprehensive legal support across a variety of commercial, regulatory, operational, and intellectual property matters related to the Company’s branded and biologic product portfolio. Reporting to the General Counsel, this role serves as a key legal advisor to the business, ensuring compliance with healthcare laws while driving innovative market access strategies and supporting the Company’s intellectual property and promotional review initiatives.


Compensation range for this position is $177,000 to $246,000. Payrate is determined by considering a person's prior experience and competence. 


Why Work with Us?

·       Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

·       Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

·       Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

·       Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

Legal Counseling:

  • Provide pragmatic, solutions-oriented legal counsel on payer and distribution contracting strategies for existing and newly launched branded and biologic products.
  • Counsel on compliance and risk mitigation for market access initiatives, including copay programs, discount strategies, and payer customer disputes.


Contract Drafting & Negotiation:

  • Draft, review, and negotiate agreements, including PBM, GPO, specialty pharmacy, wholesaler, discount/rebate, distribution, value-based, vendor, and service agreements.
  • Support the development and expansion of patient support programs across the branded and biologic product portfolio from a legal and compliance perspective.


Regulatory Guidance:

  • Advise on compliance with laws and regulations, including Medicare Parts B and D, 340b, Medicaid, Veterans Health Care Act, and state-specific drug pricing transparency laws.
  • Ensure compliance with the Anti-Kickback Statute, Fraud and Abuse, PhRMA Code, OIG guidance, and other U.S. healthcare regulations.


Intellectual Property Management:

  • Manage the Company’s intellectual property portfolio for branded and biosimilar products, collaborating with internal and external stakeholders to protect and maximize asset value.


Promotional Review and Training:

  • Lead the advertising and promotional review (Ad/Prom) process for branded and biosimilar products, ensuring materials comply with applicable laws and regulations.
  • Participate in the training and Medical-Legal-Regulatory (MLR) review process to support cross-functional teams in navigating compliance requirements.


Cross-Functional Collaboration:

  • Partner with business leaders and legal department colleagues to deliver aligned legal and regulatory guidance.
  • Develop and deliver training programs to educate internal teams on legal requirements and Company policies.


Policy Development and Compliance Monitoring:

  • Analyze policy and regulatory developments, such as the Inflation Reduction Act, to guide business strategies.
  • Draft and review standard operating procedures (SOPs) and policies to ensure alignment with legal requirements.
  • Support compliance-related initiatives, including advisory boards, patient support programs, and access strategies.
  • Conduct periodic risk assessments and audits to evaluate adherence to applicable laws.

Competencies

  • Business Acumen
  • Critical Thinking & Analytical Skills
  • Communication & Negotiation Expertise
  • Team Collaboration & Conflict Resolution
  • Proactive Problem-Solving


Qualifications

Required:

  • JD from an ABA-accredited law school and membership in a state bar.
  • Minimum of 10 years of post-JD experience in life sciences, either in-house or at a law firm.
  • Expertise in healthcare laws applicable to market access activities, including Medicaid, 340B, and anti-kickback statutes.
  • Advanced drafting and negotiating skills with exceptional attention to detail.
  • Demonstrated ability to manage multiple projects and prioritize effectively in a fast-paced environment.


Preferred:

  • In-house pharmaceutical or biotechnology legal experience.
  • Knowledge of branded and biologic products, FDA regulations, and market access strategies.
  • Experience with compliance programs, patient support initiatives, and value-based contracting.
  • Familiarity with intellectual property management and promotional review processes.


Computer Skills

  • Proficient in Microsoft Word, PowerPoint, and Excel.


AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

 

Summary

Medical Science Liaison (MSL) for Infectious Disease - Western Region - Remote


About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

The Medical Science Liaison (MSL) for Infectious Disease - Western Region will be responsible for establishing and maintaining strong, peer-to-peer relationships with Key Opinion Leaders (KOLs) and other healthcare professionals relevant to Meitheal’s infectious disease portfolio, including CONTEPO (IV Fosfomycin) and biosimilar immunologic therapies. In this role, you will provide scientific and clinical expertise to internal and external stakeholders and contribute to the implementation of Meitheal’s medical and scientific strategy. This Western Region Position will be based in the western region of the US and have a remote work schedule.


The MSL will lead strategic discussions, deliver scientific and clinical data presentations, and provide insights into health economics and outcomes research. This role requires collaboration with key stakeholders such as physicians, researchers, hospital decision-makers, formulary committees, and state Medicaid decision-makers. You will also work closely with Meitheal’s internal teams, including Marketing, Sales, and Market Access, to ensure the strategic alignment of scientific communications.


Candidates must have prior MSL experience and reside in the designated territory.


Compensation range for this position is $193,700 to $217,300. Payrate is determined by considering a person's prior experience and competence. 

Essential Duties and Responsibilities

1. Develop and maintain long-term, collaborative relationships with KOLs, scientific experts, and healthcare professionals in infectious disease at the national, regional, and local levels. Provide stakeholders with balanced medical, scientific, and pharmacoeconomic information on Meitheal’s infectious disease products, staying informed on competitive therapies and emerging trends in the therapeutic area.


2. Lead the preparation and execution of advisory board meetings for CONTEPO (IV Fosfomycin), including delivering presentations, preparing slides, and facilitating discussions. Gather insights from KOLs and healthcare decision-makers to identify data gaps and inform Meitheal’s research and development strategies.


3. Deliver internal training on disease areas and product-specific data for internal stakeholders, including Sales, Marketing, and Medical Affairs teams. Provide external educational programs to healthcare professionals and deliver clinical/scientific presentations at hospitals, addressing unsolicited medical inquiries in compliance with regulatory guidelines.


4. Act as a strategic partner by gathering insights from KOLs and healthcare professionals to influence and inform clinical development, research programs, and market access strategies.


5. Provide input into communication materials and assist in the training of new associates, such as Medical Science Liaisons and Regional Account Managers.

Qualifications

Qualifications

· Advanced degree in Life Sciences (M.D., Ph.D., Pharm.D., DPH, Ed.D.) or a minimum of an M.S. degree, with a focus on Infectious Disease, antibiotic management, and/or complex urinary tract infections. Familiarity with biosimilar immunologic agents for rheumatoid arthritis and experience in other therapeutic areas is also preferred, but not required.


· Minimum of 5 years of clinical research, pharmacy, life science, or related experience (including fellowships), with at least 2 years in the infectious disease therapeutic area.


· 5+ years of MSL experience, demonstrating a deep understanding of the medical affairs role in the pharmaceutical industry.

· Strong knowledge of the pharmaceutical corporate environment and a solid understanding of commercial operations, including Marketing and Sales strategies.


· Broad-based scientific knowledge, along with strong presentation and teaching skills, especially in communicating complex medical data to healthcare professionals.


· Proven ability to build and maintain collaborative relationships with KOLs, researchers, and healthcare decision-makers.

· Understanding of FDA regulations and compliance regarding scientific communication, along with the ability to stay current on evolving regulatory guidelines.


· Ability to gather strategic insights from healthcare stakeholders to inform product development and market access decisions.

Work Environment

· Extensive travel is required (60% or more of workdays), as MSLs often cover large geographic areas and regularly meet with healthcare professionals in their territory.


· Flexibility in work schedule, including availability for advisory boards, congresses, and weekend business activities, as needed.

· Comfort with virtual engagement platforms (Zoom, MS Teams) for meetings and scientific presentations.


Why Join Us?

  • Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
  • Work in a collaborative and supportive environment that values teamwork and common goals.
  • Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
  • Hybrid schedule – two days in the office per week.
  • Casual dress code.


AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.


Apply Now:

If you are passionate about Medical Science and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Learn about our benefits at Meitheal Benefits


Position Summary:

Member of the Meitheal team supporting the Company’s high growth objectives, goals and strategies under the guidance of the Sr. Manager, Accounting. The Sr. Accountant position will lead the month end close process, primarily leading the monthly inventory/sales process and will be responsible for delivering accurate and timely financial information to the business leaders. 


Compensation range for this position is $75,900 to $108,200. Payrate is determined by considering a person's prior experience and competence. 


Why Work with Us?

  • Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
  • Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
  • Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
  • Professional Growth: We offer ample opportunities for professional development and career advancement.


Essential Duties and Responsibilities

  • Responsible for the overall month end close process including revenue, inventory, prepaids/other assets and supply chain accounting, reconciliation and analysis
  • Provides guidance, insight and technical expertise as it relates to general accounting 
  • Prepare assigned account reconciliations and identify where adjustments are needed
  • Ensure assigned account reconciliations are properly supported
  • Works collectively with the team in identifying new process and system improvement opportunities
  • Responsible for working with our Supply Chain department and our 3PL to ensure inventory and in-transit inventory is reconciled to the general ledger
  • Reviews results on a monthly basis and provides variance analysis for our financial statement review
  • Develops/maintains accounting policies, procedures and tools/templates to comply with U.S. GAAP
  • Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers 
  • Develops, implements and reviews documentation for internal control compliance and testing
  • Assist in preparation of the year-end financial statements and footnotes
  • Provide required documentation/support to our auditors for their year-end audit
  • Independently and timely perform non-recurring, one-off projects and other analyses as delegated by the Accounting Sr. Manager


Supervisory Responsibilities

None

Competencies

  • Business Acumen
  • Positive Attitude
  • Financial Analysis Skills
  • Ethics and Values
  • Motivation
  • Critical Thinker
  • Team Player
  • Strong Analytical Skills
  • Technologically Proficient
  • Professionalism


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

  • Ability to utilize advanced finance and accounting experience to manage assigned workload
  • Excellent organization and planning skills, attention to detail and adherence to deadlines
  • Working knowledge of corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast
  • Excellent communication skills
  • Able to quickly establish a personal brand within the organization to drive cross functional collaboration
  • Curious mindset that proactively seeks understanding and feedback


Education and/or Experience Required

  • Bachelor’s degree in accounting, Finance or related areas is required.
  • CPA preferred
  • Pharmaceutical industry experience preferred
  • Minimum of 3-5 years of experience with a mixture of public accounting (Big Four preferred)
  • Solid understanding of U.S. GAAP, SEC financial reporting, and management reporting and analysis


Computer Skills

Microsoft Word, PowerPoint, Excel.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. 

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

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