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 women’s 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:

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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

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Annual
Performance-Bonus
Opportunity

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Short- and Long-Term Disability

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Paid Parental
Leave

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Employee Wellness
Resources

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Flexible Work
Arrangements

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Competitive
Wages

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Life and AD&D
Insurance

Have questions?

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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 Meitheal Pharmaceuticals


Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 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 among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good. 

 

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.


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:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. Meitheal has an established management team and an aggressive growth strategy. Through global partnerships, our goal is to bring supply to US healthcare providers that demand a reliable, high quality, yet affordable supply of injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals. Voted as a 2024 Crains Business Best places to Work employer, and Crains Business #2 on the Fast 50 list! 

By the way, we are pronounced “Mee-Hall”.


Position Summary:

The Contract Coordinator will provide administrative assistance and support to the contract marketing and marketing teams, both Generics and Specialty, at Meitheal for a variety of commercial operations and tasks including the preparation and implementation of contracts and contract documents, the review and maintenance of new customers and contract eligibility as required. Also, the review and coordination of product materials and information for databank, wholesaler and commercial customers for new product launches and product additions. The coordinator will provide analytical assistance and support in the preparation and review of rebates and fees including providing documentation and support materials, as well as custom sales reports for Meitheal customers.

Essential Duties and Responsibilities

  • Prepares contract documents for new product launches, price revisions, contract extensions, including price offers and contract amendments based on approved company templates. Uses the Link Square contract management system as required.
  • Prepares documentation and enters contract information, including fee and rebate programs into the iContracts system for assigned accounts.
  • Coordinates and aids in the preparation of new product launch information and materials for Meitheal wholesalers, distributor and data bank customers, as required. Participates in New Product Launch meetings, updates tracker, updates iContracts and prepares FCS templates as required.
  • Prepares and maintains department contract files including SharePoint, Shared Commercial Operations folder. Provides executed documents to Legal.
  • Assists in the preparation and review of monthly and quarterly rebates and fees within the iContracts system and updates and maintains the rebate tracker, as required. Provides customers’ fee and rebate sales reports per contract language.
  • Assists in the review and processing of chargeback discrepancies for assigned customers, including the review/verification/maintenance of DEA/HIN/340B identifiers and Class of Trade (COT) and the review/verification of contract eligibility.
  • Assists in the development of department policies and procedures for commercial operations contracting and commercial activities.
  • Additional ad hoc support for the team as required.


Qualifications

  • Bachelor’s degree, preferably in business or marketing, or equivalent experience required.
  • 1-3 years of experience or recent college graduate.
  • Excellent communication and organizational skills.
  • Word and Excel skills. 
  • Research skills using various databases to review customer information.
  • Self-starter and detail oriented.


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.

  

Apply Now:

If you are passionate about Contract Marketing 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:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


Position Summary:

The Director of Brand Marketing for Meitheal's Brand (Contepo) portfolio plays an instrumental role in providing leadership to ensure the Brand portfolio is properly positioned and developed to drive both short and long-term financial success. This role leads the marketing strategy including the design and implementation of the marketing/commercial plan to achieve product sales and market share expectations. Specific tactics for these Brands will focus on portfolio positioning, oversight of new product launches, lifecycle management, participation in annual budget/forecasting process and providing product support to various other internal functions.  

Essential Duties and Responsibilities

  • Develop and lead the implementation of the marketing plan(s) for the Brand portfolio.
  • Build and manage the marketing budget.
  • Develop and manage print/digital promotional materials for internal and external stakeholders.
  • Manage development, education and maintenance of sales training materials with external vendor.
  • Manage vendor relationships, ensuring quality and timely deliverables.
  • Lead Meitheal's presence at relevant medical society meetings.
  • Manage relationships with patient advocacy organizations.
  • Build effective relationships with key opinion leaders (KOLs) in the relevant disease/treatment area(s)
  • Adhere to all internal and external legal and regulatory guidelines.
  • Oversee the development of product promotional strategies, partnering with internal and external stakeholders.
  • Lead the development of product portfolio plans and strategic initiative to meet organization financial targets, overcome business challenges and drive attainment of market share.
  • 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 include one or more direct reports.

Competencies

  • Business Acumen
  • Judgement
  • Cross-functional leadership
  • Project Management
  • Ethics
  • Interpersonal Communication

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:


  • Bachelor’s Degree in a business or science related discipline with at least seven years of increasing responsibility and experience in branded pharmaceutical industry, with preference towards product management, portfolio management or marketing, or equivalent experience.
  • 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.
  • Solid understanding of biotech/pharmaceuticals, production forecasting, program and/or alliance management.
  • Product launch and brand/portfolio management experience.


Computer Skills

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

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.

Apply Now:

If you are passionate about Brand Marketing 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:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


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.

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

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


About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generics, brands and biologics. Meitheal has an established management team and an aggressive growth strategy. Through global partnerships, our goal is to bring supply to US healthcare providers that demand a reliable, high quality, yet affordable supply of injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals. Voted as a 2024 Crains Business Best places to Work employer, and Crains Business #2 on the Fast 50 list!


By the way, we are pronounced “Me-Hall”.


Position Summary:

The Medical Science Liaison (MSL) for Infectious Disease - Eastern 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 Eastern Region Position will be based in the eastern 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.

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

· 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

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


About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generics, brands and biologics. Meitheal has an established management team and an aggressive growth strategy. Through global partnerships, our goal is to bring supply to US healthcare providers that demand a reliable, high quality, yet affordable supply of injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals. Voted as a 2024 Crains Business Best places to Work employer, and Crains Business #2 on the Fast 50 list!


By the way, we are pronounced “Me-Hall”.


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.

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 headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all.


Job Summary:

Senior Director of Regulatory Affairs, Specialty Pharma, will be responsible for leading regulatory strategy for specialty pharma products, especially combination products in development and life cycle management, including A/NDA products and biosimilars.  S/he will work closely with cross-functional teams within the Company and across business partners, to prepare, review and finalize regulatory submissions, and play a critical role in the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.  


Why Work with Us?

  • Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week, balancing your professional and personal life.
  • 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

  • Provide strategic regulatory guidance on specialty pharma, especially combination products to senior management and specific project teams, from portfolio development, project execution to life cycle management. 
  • Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout combination product development.
  • Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
  • Prepare and participate in FDA meetings and EMA Scientific Advisory meetings for product development (Biosimilars, generic and innovative products), with focus on drug-device combination products.
  • Prepare and review regulatory submissions and deficiency responses to FDA, EMA, and other regulatory agencies.
  • Work with Head of Regulatory Affairs department to build up competence and capacity to enhance the efficiency and productivity of project execution as well as the approvability of submissions. 
  • Provide support to CMC and regulatory sciences of specialty pharma products, including biosimilars/biologics.

 

Competencies

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. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Qualifications


Education and/or Experience Required

  • Bachelor, Master, or Ph.D. 's degree in life sciences. An advanced degree is preferred.
  • Over 10 years related experience in product development and regulatory strategy, and/or regulatory affairs, with a minimum of 3 years in combination product area. 
  • Must have experience in preparing comprehensive packages for meetings with FDA and other regulatory agencies, developing regulatory strategies to streamline development process for efficiency and cost-effectiveness, as well as addressing challenges and deficiencies of technical complexity.
  • Expertise in drug-device combination products, including peptides, biologics or biosimilars, are highly preferred.

AAP/EEO Statement

Benefits:

  • Competitive salary and performance-based bonuses.
  • Comprehensive health, dental, and vision insurance.
  • Generous PTO and paid holidays.
  • Retirement savings plan with company match.
  • Professional development and training opportunities.


How to Apply:

Ready to join a company that values your expertise and offers a flexible and supportive work environment? Apply today to join the Meitheal team and contribute to our mission of fostering teamwork towards common goals.


Join us at Meitheal, where innovation meets flexibility. Let’s build the future together!

Meitheal is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Summary

Company Overview:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


Job Summary:

The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the company's business growth towards biopharmaceuticals.

Essential Duties and Responsibilities


  • Thoroughly understand US regulatory guidance on biosimilars; track and interpret new guidance and requirements, assessing their impact on product development.
  • Represent the regulatory function on cross-functional developmental teams for biosimilars, collaborating with Operations, Quality, Legal, and Marketing groups.
  • Prepare and review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.
  • Serve as an interface with other regulatory groups in development, manufacturing, clinical partners, and consulting services.
  • Lead preparation and management of meetings with health authorities, such as US FDA, EMA.
  • Guide the project team on the most appropriate regulatory approach from development through approval and provide post-market support.
  • Conduct due diligence and review documents from global business partners for technical and regulatory compliance.
  • Collaborate with the Head of Regulatory Affairs to build competence and capacity for biosimilars and biologics.
  • Provide training on CMC and regulatory sciences for biologics and biosimilars within the RA department and cross-functions.
  • Support CMC and regulatory sciences of complex generics, especially peptide generics.


Supervisory Responsibilities

Supervisory Responsibilities:

  • Supervise 1-3 direct reports.


Qualifications

  • Bachelor’s, Master’s, or Ph.D. degree in life sciences.
  • Over 8 years of related experience in product development and/or regulatory CMC, with a minimum of 3 years in biologics and/or biosimilars.
  • Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.


Computer Skills

Computer Skills:

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


Physical Demands


Travel:

  • Occasional travel expected (<10%).

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer Minorities/Women/Veterans/Disabled.


If you are passionate about regulatory affairs and eager to contribute to the growth of a dynamic pharmaceutical company, we encourage you to apply for this exciting opportunity. Join us at Meitheal Pharmaceuticals, where teamwork and innovation drive our mission to improve patient access to essential medications.

Summary

Senior Medical Science Liaison (MSL) for Infectious Disease - Central Region - Hybrid


About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generics, brands and biologics. Meitheal has an established management team and an aggressive growth strategy. Through global partnerships, our goal is to bring supply to US healthcare providers that demand a reliable, high quality, yet affordable supply of injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals. Voted as a 2024 Crains Business Best places to Work employer, and Crains Business #2 on the Fast 50 list! 


By the way, we are pronounced “Me-Hall”.


Position Summary:

The Senior Medical Science Liaison (MSL) for Infectious Disease 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 Central Region Position will be based out of our Chicago corporate headquarters and have a hybrid work schedule. 


The Senior 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.

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

· 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:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


Position Summary:

The Associate, Supply Chain Traceability is responsible for managing the requirements of the Drug Supply Chain Security Act (DSCSA) and ensuring Meitheal is in compliance. This role will be accountable for the reconciliation and verification of inbound and outbound data scans ensuring that our scans match our shipments. This role is responsible for the notification and resolution of serialization efforts with our customers, internal manufacturing sites, and Contract Manufacturing Organizations (CMO’s) in a timely and professional manner. This Associate is responsible for managing relationships with 3rd party logistics providers (3PL), internal, and external Customers. Individuals may be tasked with key strategic efforts to drive cost savings and service improvement opportunities.

Essential Duties and Responsibilities

  • Develop and implement process and procedures to exchange serialization data with downstream partners •Function as primary contact for all serialization activities for Meitheal
  • Onboard new partners and products for exchange of serialization information
  • Resolve data transmission errors and exceptions
  • Evaluate and develop internal and external SOPs to ensure Meitheal is in compliance with current and future DSCSA requirements Manage master data to ensure accurate data exchange with upstream and downstream trading partners
  • interact various cross-functional teams to provide support and ensure timely completion of tasks in alignment with corporate goals and new product launches
  • Be the DSCSA subject matter expert for Meitheal, understanding future serialization requirements, impact to the company and working cross-functionally to ensure compliance by the mandated timeframe


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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:


  • Ability to remain agile and flexible as the role demands effectively managing several priorities at once, sometimes under deadline pressure and always in a challenging and dynamic environment.
  • Detail focused with exceptional organizational skills.
  • Proven ability to show initiative and sense of urgency.
  • Ability to identify problems and formulate solutions.
  • Diplomacy and persuasiveness with internal and external customers.


Education and/or Experience Required

Required

  • ·Bachelor’s degree in business, Supply Chain, Information Technology, or 1-3 years equivalent experience.


Preferred

  • Work experience in pharmaceuticals and/or manufacturing environments
  • Knowledge of the Drug Supply Chain Security Act (DSCSA) requirements
  • Experience using TraceLink or another Track and Trace service provider (LSpedia, TrackTraceRX, rfXcel. Etc.…)

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint), ERP systems (SAP, Oracle), TraceLink.

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.

  

Apply Now:

If you are passionate about Supply Chain Traceability 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.

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