Summary

About Us:

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

Position Summary:

The Pricing Analyst for Meitheal Pharmaceuticals Inc. (“Meitheal”) will be responsible for providing analytical support related to all aspects of commercial pricing and contract activities at Meitheal. The Pricing Analyst will focus on providing direct day-to-day operational and tactical support to the VP, Commercial Analytics & Optimization. Additional support will be provided cross-functionally (Product Management/Marketing, Contract Marketing, Sales, National Accounts, Finance, Trade Relations) to aid in meeting annual sales and profit goals.

Candidates should be comfortable and confident, challenging assumptions within a business model, have experience working with large amounts of unstructured data and be a self-starter who develops strategic analyses that informs and drives business decisions.

The compensation range for this position is $70,000 to $85,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

• Communicates detailed examination, trend analyses and recommendations to management and other stakeholders.
• Recommend actions by analyzing and interpreting data, and supporting recommendations with detailed analyses (i.e. market competitive trends, customer specific trending)
• Supports the pricing team in the management of the Meitheal Price Review Committee (support analysis development, prepare agenda and visual aids, meeting minutes distribution)
• Acts as project manager and provides analytical support / guidance for major GPO bids/RFPs. 
• Anticipates the consequences of price changes and business decisions while weighing multiple factors and review as appropriate with management.
• Develops and manages templates used to analyze and interpret data.
• Supports the financial forecasting, budgeting, and long-term planning process.
• Manages contract compliance reporting, ITS claim analysis and provides recommendations to management
• Manages the collection of market landscape intelligence and provides reporting output.
• Works closely with National Accounts, Trade and Sales teams to provide analytical support, reporting, and responses to inquiries on a regular basis.
• Helps manage product listings and information required for customer online interfaces.
• Other duties may be assigned.

Supervisory Responsibilities

None

Competencies

• Teamwork
• Professionalism
• Strategic Thinking Skills
• Analytical Skills
• Interpersonal
• Project Management
• Ethics

Qualifications

Education and/or Experience Required

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 from four-year college or university.
• Minimum of 3 years in pharmaceutical industry in analytics and related experience.
• Experience working with data (large datasets, data cleansing, data mapping, etc.)
• Strong analytical skills with high focus on preparation, attention to detail and accuracy
• Ability to work in a proactive, fast-paced environment and flexibility to adjust to changing organizational needs
• Excellent interpersonal skills with ability to work individually within a multi-disciplinary team.
• Strong verbal and written communication skills.

Computer Skills

•  Must have advanced skills in Microsoft Excel with proficiency in other Microsoft Office suite applications preferred (Word, PowerPoint, Access)
•  Experience with Tableau or other business intelligence software.

AAP/EEO Statement

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

Summary

About Us:

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

Position Summary:

The Associate Director, Sales Operations is responsible for leading and optimizing the sales operations function to drive efficiency, effectiveness, and productivity within the commercial sales, marketing, and virtual sales teams. This role involves strategic planning, process improvement, data analysis, a focus on optimization, and cross-functional collaboration to support the achievement of sales targets and business growth.

The compensation range for this position is $140,000 - $180,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

Strategic Planning and Execution:

• Develop and implement sales operations strategies (e.g., sample management, sales territory design, sales incentive design and implementation, commercial workforce optimization) that align with overall business objectives.
• In collaboration with senior leadership, define and implement operational projects which help achieve sales goals and deliver revenue.

Sales Process Optimization:

• Analyze and refine sales processes to improve efficiency and effectiveness.
• Implement best practices and tools to streamline sales activities and enhance productivity.
• Define and improve sales force effectiveness metrics.
• Assess and develop sales operations training, as required.

Sales Incentive Compensation Leadership

• Lead the development, administration, budgeting, and effectiveness of sales incentive compensation plans.
• Carefully develop and manage sales incentive compensation budgets in partnership with commercial finance.
• Lead the development and communication of sales incentive compensation.
• Develop and implement incentive compensation governance programs.

Sales Data Analysis and Reporting:

• Oversee the collection, analysis, and reporting of sales data to provide insights and recommendations.
• Work cross-functionally to develop and maintain dashboards and reports to track key performance indicators (KPIs) and sales metrics.

Cross-Functional Collaboration:

• Work closely with marketing, finance, product, and customer success teams to ensure alignment and support for sales initiatives.
• Facilitate communication and collaboration between sales and other departments.

Technology and Tools Management:

• Evaluate, implement, and manage sales technology and tools, such as CRM systems (Veeva), reporting systems, and related data structures to support sales operations.
• Ensure the effective use of technology to enhance sales processes and data management.

Budget Management:

• Develop and manage the sales operations budget, ensuring efficient allocation of resources.
• Monitor expenses and optimize costs to achieve financial targets.

Contract compliance:

• Develops and manages enhanced Tableau-based contract compliance tools; provides monthly reports and presents updates to senior leadership on GPO, IDN, Wholesaler and other key contract performance metrics.

Competencies

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

Qualifications

• Bachelor’s degree in business administration, Sales, Marketing, or a related field; MBA preferred.
• 7+ years of experience in pharmaceutical sales operations, with at least 3 years in a leadership role.
• Strong analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.
• Proficiency in sales technology and tools, such as CRM systems (e.g., Salesforce, PowerBI, Varicent, etc.).
• Proven track record of driving sales process improvements and achieving sales targets.
• Strong leadership and team management skills.

AAP/EEO Statement

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

Summary

About Us:

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

Position Summary:

The Marketing Manager for Meitheal's Brands (CONTEPO and XENLETA) 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 marketing planning and execution, including the design and implementation of marketing strategies, conference and event strategies, and sales support to achieve product sales and market share expectations. Specific tactics for these Brands will focus on developing digital marketing channels that leverage paid, organic, and earned media sources to generate leads and foster existing customer relationships, support new product launches and lifecycle management, and provide product support to various internal functions including sales.

The compensation range for this position is $100,000 to $150,000

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

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



• Develop and lead the implementation of the marketing campaigns for the Brand portfolio. 
• Develop and lead print/digital promotional materials for internal and external stakeholders. 
• Lead the development, education and maintenance of product tools (brochures, website, sales collateral, etc.). with external vendors. 
• Collaborate with the sales team to conceptualize or iterate on marketing materials.
• Manage vendor relationships, ensuring quality and timely deliverables. 
• Lead the planning and management of conferences, society meetings, and displays for the Brand portfolio.
• Lead the planning and management of corporate sponsored events for the Brand portfolio.
• Manage the advertising and promotional approval process for the Brand portfolio's promotional materials.
• Adhere to all internal and external legal and regulatory guidelines. 

Supervisory Responsibilities

None

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 accommodation 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 five years of experience in branded pharmaceutical industry, with preference towards product management or marketing. 
• 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. 
• 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. 
• Solid understanding of the advertising and promotional process for Branded biotech/pharmaceuticals. 
• Conferences, event management, and planning experience.
• Experience working in a cross-functional environment.
• Product launch and brand/portfolio management experience. 

Preferred

• Advanced degree (MBA/MS.)
• Experience with global operating structures.
• Experience with Veeva PromoMats.

Computer Skills

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

Position Summary:

The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. 

The pay range for this position is: $85,000 - $115,000. 

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

The primary responsibility will include authoring, reviewing and preparing high quality ANDA, NDA, BLA, IND and DMF submissions.

· Prepare, review and submit responses to FDA’s CRLs, DRLs and Information Requests within predetermined and negotiated deadlines.

· Review and submit post-approval supplements, safety update reports to INDs, NDAs, ANDAs and BLAs.

· Participate in development and commercial team meetings representing RA CMC.

• Review and approve change controls from global manufacturing partners 

• Experienced with FDA’s eCTD requirements for Modules 1-5. 

• Work in a collaborative environment with cross-functional teams, not limited to Labeling, R&D, Manufacturing, Medical Affairs, Operations, Marketing and Quality.

• Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.

• Maintains current knowledge of regulations. Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements.

• Support Biosimilar BLA/PAS/CBE submissions, as assigned.

Competencies

• Planning and Organizing
• Communication
• Strategic Thinking
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

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.

• 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: 

• Bachelor's degree in life sciences from a 4-year college or university with 5 or more years of direct experience in Regulatory Affairs within bio/pharmaceutical companies, with focus in CMC. Candidates with additional prior experience in R&D or Manufacturing will be a plus.
• Excellent attention to details, technical writing, organizational and communication skills.
• Ability to prioritize and handle multiple projects concurrently.
• Familiar with 21 CFR, FDA and ICH.

AAP/EEO Statement

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

Summary

About Us:

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

Position Summary:

Sr. Analyst, IT Support is responsible for monitoring and managing the daily operations of the IT department, managing technical teams (internal / external resources) as needed, implementing and monitoring cybersecurity measures to protect company data and ensuring the organization’s technology infrastructure runs smoothly.

The pay range for this position. Payrate is determined by considering a person's prior experience and competence.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

• Oversee the installation, configuration, and maintenance of hardware, software, and networks.
• Ensure system security, data integrity, and backup processes.
• Monitor system performance and troubleshoot issues promptly.
• Manage help desk operations to resolve user issues effectively.
• Develop and enforce IT support procedures and service-level agreements (SLAs).
• Manage relationships with third-party vendors and service providers.
• Evaluate and recommend new technologies, tools, and systems.
• Implement and monitor cybersecurity measures to protect company data.
• Ensure compliance with industry regulations and company policies.
•  Assist in developing and managing the IT budget.
• Review and advise on the purchases of all hardware, software, and automation-related services.
• Ensure sufficient systems capacity for immediate organizational needs and plan appropriately for the future.
• Identify opportunities for process improvements and technology upgrades.
• Stay updated on industry trends and emerging technologies.
• Assign tasks and projects to team members (internal and external) based on skills and workloads.

Supervisory Responsibilities

None

Competencies

• Strong problem-solving abilities with a customer focus
• Detail focused with exceptional organizational skills 
• Strong written and oral communication skills
• Able to build and manage relationships with others
• Effective cross-functional team member, as a leader and team member
• Adaptability and Flexibility
• Strategic Thinking; skilled at troubleshooting and mitigating risks
• Cost conscious
•  Address user and team concerns diplomatically

Education and/or Experience Required

Education and/or Experience

• Bachelor’s degree or equivalent work experience in information technology, network administration, or related field
• 3–5 years of hands-on experience in IT support, systems administration, network management, or infrastructure management.
• Proficient in Office 365, MS exchange email, and Share Point. 
• Experience managing IT projects, including system upgrades, network implementations, and software deployments.
•  Knowledge of cybersecurity best practices and regulatory compliance.
• Experience with help-desk management systems and IT support tools.

Language Skills

Ability to read, analyze, and interpret 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 employees at all levels of the organization.

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. Ability to identify potential risks and mitigate such risks to ensure on-time deliveries.

Computer Skills

• Operating Systems: Windows Server, Linux/Unix, macOS
• Network Management: TCP/IP, DNS, DHCP, VPN, VLAN, and firewall configurations
• Active Directory (AD): User and group management, Group Policy Objects (GPO)
• Virtualization: VMware, Hyper-V, or VirtualBox for server and desktop virtualization
• Cloud Platforms: AWS, Microsoft Azure, Google Cloud Platform (GCP)
• Cloud Services: Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Software as a Service (SaaS)
• Security Protocols: SSL/TLS, VPN, multifactor authentication (MFA)
• Compliance Standards: GDPR, HIPAA, PCI DSS, ISO/IEC 27001
• Hardware Knowledge: Servers, desktops, laptops, network devices, and mobile devices
• Collaboration Platforms: Microsoft Teams, Slack, Zoom

Work Environment

Travel

• This position requires occasional travel.

AAP/EEO Statement

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

Summary

About Us:

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

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

Learn about our benefits at Meitheal Benefits

Position Summary:

The Senior Associate of Regulatory Affairs, Labeling, is responsible for providing effective support to the Labeling function in Regulatory Affairs, in compliance with the FDA regulations, 21 CFR Part 201 and internal labeling policies and/or procedures.

The pay range for this position is $70,000 to $85,000. Payrate is determined by considering a person's prior experience and competence. 

Why Work with Us?

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

Essential Duties and Responsibilities

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

• Performs daily labeling functions in Regulatory Affairs which includes creation of draft labeling, revision of current labels and/or FDA deficiency letters.
• Creation and maintenance of all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files to ensure accurate rendering for all products.
• Makes strategic and critical decisions regarding patents, carve-outs and labeling content.
• Assesses labeling processes and practices for efficiency and continual improvement.
• Format/develop labeling annotations and deficiency responses.
• Meet deadlines and goals in a timely manner.
• Proofreading and annotating label copy to the highest quality standards.
• Ability to document changes and justification by developing and creating change controls.

Supervisory Responsibilities

Competencies

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

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.

Education and/or Experience

Bachelor's degree in life sciences from a 4-year college or university; over 4 years related experience and/or training; or equivalent combination of education and experience.

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.

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

Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio

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

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and brand products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

Position Summary

The Regulatory Affairs Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required.

The estimated salary range reflects an anticipated range for this position of $70,000 to $85,000. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Essential Duties and Responsibilities

• Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications.
• Manage pre-approval, post-approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE-0, CBE-30, Amendments, Supplements, and Safety Reports.
• Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements.
• Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports.
• Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead.
• Handle ANDA, NDA, and BLA submissions for pre-approval, post-approval, and promotional materials, supporting full product lifecycle management.
• Develop and maintain an in-depth understanding of relevant US and EU regulatory requirements for submissions.
• Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance.
• Perform administrative tasks related to submissions, including transferring files via FTP servers.
• Input submission information into internal databases and systems per company procedures.
• Perform other duties as assigned to support Regulatory Affairs publishing operations.

Supervisory Responsibilities

None

Competencies

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgement
• Dependability

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

Bachelor's degree from a 4-year college or university; over 3-4 years pharma experience and/or training; or equivalent combination of education and experience.

Computer Skills

Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc.).

Physical Demands

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

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

About Us:

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

Position Summary:

The Senior Manager of Regulatory Affairs, Advertising and Promotions is responsible for coordinating the Medical, Legal, and Regulatory Affairs (MLR) review and approval process and performing regulatory review for promotional and informational materials for branded, generic, and biosimilar products of the Company in the US. Provides expertise concerning the FDA’s requirements for the promotional materials and safeguards the practices to adhere to the highest quality and regulatory standards. Utilizes strong organization and communication skills to coordinate cross-functional teams, track submissions, and maintain documentation. Ensures compliance with internal policies, company guidelines, and external regulatory requirements. Has cross-functional influence at all levels and leads the department as a subject matter expert (SME) for Regulatory in MLR review. This individual is to share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

The compensation range for this position is $115,000 - $150,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

• Manages the end-to-end MLR process for submitting (requesting), reviewing, and approving promotional materials, ensuring they are compliant with regulations (the Code of Federal Regulations (CFR), FDA guidance, PhRMA Guiding Principles, etc.) and approved company policies and procedures.
•  Establishes strong working relationship with cross-functional review and supporting team members (internal and external), to facilitate feedback and approvals.
•  Aligns and maintains effective communication channels with key counterparts, Marketing, Corporate Strategy, Medical Affairs, Legal and Compliance as well as external partners and consultants.
•  Makes challenging decisions based upon sound regulatory knowledge or makes propriate assessment for elevating to upper management for further consideration.
• Approve FDA submission for Advertising and promotions, such as 2253 forms.
• Works closely with RA labeling group regarding label changes and packaging insert changes to ensure the promotional Prescribing information (PI) and ISI (important Safety Information) are updated as appropriate.
• Maintain accurate records of submissions, approvals, comments, and version control for audit purposes.
• Help identifies and address bottlenecks in the review process and may contribute to developing playbooks or best practices.
• Identifies areas of improvement in process, policy, develop recommendations and leads initiatives.
• Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies. Maintains awareness of pending changes to communicate impact and relevance to the relevant teams.
• Perform all other duties assigned by supervisor.

Supervisory Responsibilities

Competencies

• Regulatory Knowledge of Advertising and Promotion
• Project Management
• Change Management
• Communication
• Ethics
• Teamwork
•  Problem Solving
• Judgement
• 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

Bachelor's degree in life sciences from a 4-year college or university a plus; over 6 years related experience and/or training, or equivalent combination of education and experience in regulatory affairs and/ or medical affairs. Regulatory experience in Advertising and Promotion is strongly 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 public.

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.

AAP/EEO Statement

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

Summary

About Us:

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

Position Summary

The Vice President, Generic Commercialization leads their teams in strengthening & expanding Meitheal’s relationships with Group Purchasing Organizations (GPOs), Integrated Delivery Networks (IDNs), Fertility Pharmacies and other key customers/partners. The role has responsibility for developing the strategic vision and business strategy that positions Meitheal to achieve the organization’s market share, revenue, and profit goals. The Vice President, Generics Commercialization reports to the Senior Vice President, Commercial - Generics.

This individual will lead all organizational and day to day activities related to sales, national accounts & fertility including: team leadership and development; creation and execution of successful product, contracting, market intelligence and business strategies; providing effective cross-functional direction and collaboration across all Meitheal Pharmaceuticals business functions such as: Marketing, Contract Marketing, Operations, Supply Chain, Quality, Regulatory, Legal and Finance.

The salary range for this position is $230,000 to $300,00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

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

• Provides leadership to the Sales, National Accounts & Fertility teams and across the organization, while fostering a culture of teamwork, accountability, professional development and high-performance.

• Develops robust, detailed, and structured performance goals & objectives.

• Identifies growth and development opportunities for team members and provides measurement & reporting tools for key performance indicators.

• Provides insight on GPO, Alternate Site, 340B/Apexus, IDN customer channels, Fertility Pharmacies and Specialty Distributors, as well as competitive intelligence and emerging trends in the industry.

• Leverages external relationships to enhance strategic partnerships and company profitability.

• Provides leadership and direction to the team in obtaining pertinent information that supports Meitheal’s go-to-market strategies.

• Coordinates and leads effective internal and external business meetings with clear, direct communication and decision-making.

• Supports day-to-day activities of the Sales, National Accounts & Fertility teams, and provides leadership to ensure effective communication, sales positioning, contracts strategy, and negotiation efforts are implemented that support achieving both individual and company goals.

• Presents internal and external recommendations on business opportunities to drive growth in support of Meitheal’s overall business objectives.

• Works cross functionally with Contract Marketing, Product Management, Pricing and Legal to develop effective strategies for contract/product offers, bid processing, Terms & Conditions language, and post award compliance tracking.

• Collaborate with executive leadership and present internal/external recommendations on business opportunities in support of team and company goals.

• Supports solution development efforts that best address team and organizational needs, while coordinating the involvement of all necessary company personnel.

• Support the achievement of strategic objectives critical to other functional areas within the organization.

• Promotes the Meitheal Culture through positive interpersonal interactions.

• If this is not located in the corporate office (Chicago, near O’Hare), regular travel to the corporate office will be required.

Supervisory Responsibilities

This position is responsible for leading and developing the Sales, National Accounts & Fertility teams.

Competencies

• Teamwork

• Professionalism

• Strategic Thinking

• Judgement

• Ethics

• Interpersonal Skills

• Project Management

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's degree from four-year college or university.

• A minimum of 15 years in the pharmaceutical industry with Sales, National Accounts, Marketing and Contracts Management related experience.

• Experienced in establishing and growing customer and other business partnerships or equivalent combination of education and experience.

• Attention to detail and ability to work individually, while also leading a multi-disciplinary team. 

• Strong verbal, interpersonal and written communication skills. 

Physical Demands

Must be willing and able to travel 50% of the time and have high energy level

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.