Summary

About Us:

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. 

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. 

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.

Summary

About Us:

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. 

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.

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 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 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. 

The Director, Inside Sales & Commercial Effectiveness, is responsible for leading a team of Inside Sales Representatives (ISRs) to achieve and exceed sales targets for the Generics portfolio. Responsibilities include providing personalized coaching and constructive feedback to direct reports, collaborating effectively with internal and external stakeholders to identify targeting and optimize results, and supervising the day-to-day operations of the ISRs, ensuring smooth workflows and efficient processes. This role will cultivate a team culture of excellence, high performance and collaboration. The Director will partner with the Senior Director, Generics, to establish and monitor objectives and results for the Inside Sales team, assist with onboarding new team members, and mentor and coach ISRs. 

The ideal candidate must demonstrate the ability to achieve strong sales results through leading a team, sales and business acumen, proven ability to learn complex technical material (generic pharmaceuticals preferred), and excellent communication and interpersonal skills. The successful candidate will also demonstrate the ability to work effectively in a key cross-functional role with internal and external stakeholders. Additionally, this position may require a high degree of customer interaction and communication to ensure the customer experience is positive and professional, while consistently focusing on gaining customer buy-in of the Meitheal Generics portfolio.

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.

Essential Duties and Responsibilities

• Commercial Strategy Development: Collaborate with Generics leadership to execute a comprehensive commercial strategy for the injectable portfolio and ensuring alignment with overall business objectives.
• Sales Performance Management: Establish and monitor key performance indicators (KPIs) for sales teams, analyzing performance data to identify trends and areas for improvement.
• Inside Sales Management: Lead the inside sales team, providing guidance, support, and resources to enhance     performance and drive revenue growth. Inspire and motivate the virtual sales team to achieve individual and collective goals, fostering a culture of accountability and high performance. Assist with negotiation/capture of contracts with key hospital accounts.
• Training & Development: Design and implement training programs focused on data literacy, CRM usage, and effective sales techniques, ensuring teams are equipped to utilize insights for improved performance.
• Process Optimization: Evaluate and refine sales processes, focusing on integrating technology and best practices to enhance efficiency and effectiveness across the sales organization.
• Market Insights: Conduct market research to identify industry trends, competitive dynamics, and customer needs specific to injectable pharmaceuticals, translating findings into actionable sales strategies.
• Collaboration with Cross-Functional Teams: Work closely with marketing, medical affairs, commercial ops, and customer service to ensure alignment in messaging, support for sales initiatives, and exceptional customer experience.
• Sales Enablement: Develop and distribute sales enablement tools and resources, ensuring sales teams are equipped to engage effectively with healthcare professionals.
• Change Leadership: Champion a culture of continuous improvement within the inside sales organization, leading initiatives that promote agility and adaptability in a rapidly changing market.
• Data Analysis & Reporting: Utilize advanced analytics to assess sales performance, market trends, and customer behavior. Develop dashboards and reporting tools to provide actionable insights to the sales teams and senior management.
• IT Solutions Implementation: Oversee the selection and implementation of sales technology and tools (e.g., CRM systems, sales force automation tools) that enhance productivity and streamline operations. Collaborate with IT teams to ensure systems are optimized for sales processes.
• Feedback Loop: Establish and manage a feedback mechanism to gather insights from the sales team about customer interactions and market trends, informing ongoing strategy adjustments.
• Motivation & Recognition: Implement recognition programs to celebrate individual and inside sales team achievements, fostering a positive and motivating work environment. Create incentives that reward performance and encourage team members to exceed their sales goals.

Competencies

• Building and maintaining interpersonal relationships.
• Analyzing data and drawing meaningful conclusions.
• Developing and executing strategies and action plans (e.g., sales, commercial effectiveness).
• Monitoring results and developing / executing plans to fill any gaps.
• Managing, motivating and leading inside sales professionals.
• Listening to needs and developing / implementing solutions.
• Communicating information in a clear and impactful manner, via verbal and written means.
• Negotiating with customers and internal stakeholders.
• Driving sales of generic injectable products to meet / exceed targets.
• Leading cross-functional teams effectively to achieve individual and team goals.

Qualifications

• Bachelor’s degree, preferably in business or life sciences, and MBA preferred; or equivalent skills and experience required.
• 7+ years of experience in sales management within the pharmaceutical or biotech industry, with specific experience     in injectable products.
• Proven track record in managing sales teams and driving sales effectiveness.
• Strong analytical skills, with the ability to interpret data and derive actionable insights.
• Excellent leadership, communication, and interpersonal skills, capable of influencing stakeholders at all levels.
• Proficient in CRM software and sales analytics tools; experience with sales force automation is a plus.
• Knowledge of industry regulations and compliance related to pharmaceutical sales.

Education and/or Experience Required

• Bachelor’s degree, preferably in business or life sciences, and MBA preferred; or equivalent skills and experience required.
• 7+ years of experience in sales management within the pharmaceutical or biotech industry, with specific experience     in injectable products.
• Proven track record in managing sales teams and driving sales effectiveness.
• Strong analytical skills, with the ability to interpret data and derive actionable insights.
• Excellent leadership, communication, and interpersonal skills, capable of influencing stakeholders at all levels.
• Proficient in CRM software and sales analytics tools; experience with sales force automation is a plus.
• Knowledge of industry regulations and compliance related to pharmaceutical sales.

Computer Skills

General computing skills, along with proficiency with Microsoft Office products and CRM systems

Physical Demands

Some travel is expected.

AAP/EEO Statement

Meitheal Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type 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.

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

About Us:

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. 

Position Summary:

Manager, Project Management (PM), will be responsible for managing injectable pharmaceutical development projects of higher complexity and/or strategic importance to corporate strategy, including complex generics, combination products, biosimilars, and branded products. The successful candidate will drive cross-functional teams within the Company and across business partners to manage project milestones and goals. Experience/knowledge in peptide, biosimilars, and/or combination product development is highly preferred.

The PM will play a key role in the development and execution of the product development plans, ensuring that cross-functional teams are aligned on goals, technical strategy, timelines. This role will also require effective communication across all functional areas, at various levels, including Executive Management.

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

• Planning and tracking of projects in support of Research and Development (R&D) and business objectives.
• Supports drug development for U.S. market in a highly cross-functional internal environment, as well as with international drug development and manufacturing partners.
• Facilitates cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership.
• Independently manages all development projects to meet exhibit batch and submission goals.
• Executes frequent international project team calls, issue agendas, notes and conduct all follow ups.
• Manages all project team activities to resolve technical issues and to ensure all project goals and timelines are achieved by interacting with key stakeholders across divisions and influencing others internally and externally to complete their assigned tasks on schedule.
• Acts as liaison between R&D and CROs/CMOs for contracted projects.
• Assesses project risk and supports mitigation planning and follow up.
• Generates and publishes project status reports and other reports as needed.

Supervisory Responsibilities

None

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.

• Past experience/knowledge in peptide, Biologic, and/or combination product development preferred.
• Demonstrated experience in managing multiple pharmaceutical projects within the product development process.
• Detail focused with exceptional organizational skills. 
• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

• Bachelor of Science in Pharmacology, chemistry or related discipline preferred; or, equivalent skills and experience required.
• 5 years of pharmaceutical experience.
• 5 or more years of experience in product development and/or project management in pharmaceutical drug development.
• Skilled at troubleshooting and mitigating risks for multiple projects at a time to meet corporate goals. 

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint).

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 - 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). 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 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. 

Position Summary:

As National Sales Leader - Contepo, you will play a pivotal role in driving our sales strategy and achieving revenue targets. Reporting to the Director of Product Marketing, you will lead and mentor a team of account managers. This role requires strategic thinking, strong leadership skills, fostering a culture of high performance and customer-centricity, and a passion for driving business growth.

The National Sales Leader role requires expertise in developing sales strategies, expanding markets, fostering employee development, and collaborating cross-functionally within the organization. Additionally, the role demands proficiency in accurate business forecasting, budget monitoring, and effective utilization of resources.

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 and execute strategic sales plans to achieve annual and quarterly revenue targets aligned with the company’s objectives and market dynamics.
• Monitor sales performance metrics, analyze data, and generate reports to track progress and pinpoint areas for improvement. 
• Ensure accurate sales forecasting and pipeline management to support business planning and resource allocation.
• Ensure that account managers can accurately deliver selling messages to effectively position Meitheal products within the context of the provider’s setting and payer mix.
• Achieve business objectives and sales results by observing account managers with target customers, extended treatment team members and ancillary staff, and providing them with individual coaching, feedback and inspiration. 
• Help account managers continue to develop for success in their current roles, and for future growth.
• Set and maintain product knowledge and selling skills standards within the team. 
• Establish a result-driven, highly collaborative team culture by demonstrating personal accountability, teamwork, and collaboration.
• Establish and maintain strong relationships with key clients and strategic partners to drive business growth and expansion and identify strategic relationships that are valuable to the business (e.g., key opinion leaders, advocacy partners).
• Analyze market trends and competitor activity to identify new opportunities and areas for growth. Stay abreast of industry     developments, best practices, and emerging trends to maintain a competitive edge in the market.
• Facilitate sales execution with the sales force by ensuring collaboration with internal cross-functional partners such as medical, marketing, and sales operations.
• Provide essential tools and resources for the sales team to attain their objectives effectively, which includes sales training     initiatives.
• Develop and refine sales processes, tools, and methodologies to enhance efficiency and effectiveness.
• Represent the company at industry events, conferences, and networking opportunities to build brand awareness and foster strategic partnerships.
• Lead charge of overseeing sales forecasts, metrics, and tracking systems to enhance performance and ensure alignment with strategic objectives.

Competencies

• Business Acumen
• Judgement
• Change Management
• Project Management
• Ethics
• Interpersonal

Qualifications

• Bachelor's Degree preferred, or equivalent skills and experience required.
• Prior experience with antibiotic sales in hospitals, and to other healthcare professionals.
• Strong understanding of antibiotics and their application by healthcare practitioners.
• 7+ years of progressive experience in sales leadership roles, with a proven track record on driving revenue growth and building / managing high-performing teams.
• Proactive and results-oriented mindset, with a focus on achieving and exceeding sales targets. 
• Strong business acumen and a deep understanding of sales strategies, methodologies, and best practices.
• Strong communication, negotiation, and presentation skills essential for effective interaction with internal and external stakeholders. 
• Must possess exceptional interpersonal and organizational abilities.
• Strategic thinker with a focus on delivering exceptional customer experiences.
• Analytical mindset with the ability to leverage data to drive decision-making and sales performance improvements.
• Proven ability to develop and execute strategic sales plans, analyze market trends, and identify growth opportunities.
• Proven track record of leading, coaching and developing sales professionals.
• Proficient in forecasting, managing budgets and utilizing commercial resources.
• Previous experience with launching products is required.
• Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Meitheal.

Education and/or Experience Required

• Bachelor's Degree preferred, or equivalent skills and experience required.
• Prior experience with antibiotic sales in hospitals, and to other healthcare professionals.
• Strong understanding of antibiotics and their application by healthcare practitioners.
• 7+ years of progressive experience in sales leadership roles, with a proven track record on driving revenue growth and building / managing high-performing teams.
• Proven ability to develop and execute strategic sales plans, analyze market trends, and identify growth opportunities.
• Proven track record of leading, coaching and developing sales professionals.
• Proficient in forecasting, managing budgets and utilizing commercial resources.
• Previous experience with launching products is required.

Physical Demands

Travel

• Requires the ability and willingness to travel extensively (up to 50% of the time) across the U.S. for customer meetings, internal business gatherings, seminars, and conferences.
• Field-based role, so remote working is required.

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 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. 

Position Summary:

The Quality Assurance Specialist position is responsible for Meitheal's Document and Training Management Programs. This will require working with our external Safety Data Sheet Vendor, monitoring the periodic review process for controlled documents, supporting day-to-day activities associated with the document lifecycle, monitoring training, performing annual training assessments and supporting the change control, batch review and new product launch activities, as needed. Previous experience with documents or training management in a CGMP environment is a plus. This is a Chicago-based hybrid role. 

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 Administration of Meitheal's Document Management Process
• Works in collaboration with Safety Data Sheet Vendor and contract manufacturing partners to obtain necessary documents for vendor to develop Safety Data Sheets.
• Initiates, processes and monitors Meitheal Controlled Documents within Meitheal's TrackWise Digital System including but not limited to Policies, Procedures, Work Instructions and Safety Data Sheets.
• Formats red-lined or updated Controlled Documents in collaboration with document owners, as necessary
• Monitors Controlled Document periodic review cycle updates and works in collaboration with Document Owners, external vendors, and partners, as applicable, to meet review timelines.
• Responsible for Administration of Meitheal's Training Management Process for all departments.
• Creates new and updates existing Training Plans in TrackWise Digital in collaboration with department management.
• Creates on the Job Training in TrackWise Digital in collaboration with department management, as needed.
• Creates Training Quizzes in TrackWise Digital, in collaboration with document or training owners, as needed.
• Assigns training within TrackWise Digital system to new employees and existing employees, as needed.
• Monitors Meitheal's employees training to completion ensuring training timelines are met.
• Prepares and Presents Annual CGMP presentation in collaboration with other Quality team members. 
• Conducts Annual Training Assessment.
• Conducts New Employee Training for TrackWise Digital, Adobe Sign, and Master Product Portal.
• Prepares training metrics for Management Review.
• Supports management during external inspections.
• Remains current in regulatory trends and requirements.
• Other duties as assigned.

Supervisory Responsibilities

None

Competencies

Competencies

• Code of Federal Regulations and cGMP’s
• Strong written and oral communications skills
• Planning and Organizing
• Interpersonal
• Teamwork
• Problem Solving
• Quality Management
• Judgement
• Dependability
• Ethics

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. 

• Bachelor’s degree in science or equivalent degree. 
• 2-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry.
• Knowledge of CGMP and GDP as well as FDA trends and guidelines.
• Strong interpersonal skills required.
• Must be a team player with good problem solving and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently.
• Ability to manage indirect relationships and projects successfully.
• Strong organization skills and attention to detail required.

Education and/or Experience Required

Computer Skills

Microsoft Word, PowerPoint, Excel, TrackWise Digital, Adobe Sign preferred but not required.

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. While performing the duties of this job, the employee may have to sit for prolonged periods, stand and walk occasionally while in office. The employee is frequently required to talk or hear.

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.

Summary

About Us:

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. 

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. 

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.

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

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). 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.