Summary

About Us: 

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all. 

Job Summary:

The Associate Counsel will support the Legal Department in various commercial and corporate matters, helping multiple business units including Sales, National Accounts, Marketing, Regulatory, Quality, Operations, Corporate Strategy, and Human Resources. This role will report to the General Counsel or other Senior Counsel.

Why Work with Us?

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

Essential Duties and Responsibilities

• Review, draft, and negotiate various types of agreements (Service Contracts, Vendor Contracts, NDAs, Product Purchase Agreements, etc.).
• Provide legal guidance on regulatory, contractual, and operational matters, including interpreting and implementing legislation, regulations, and rules.
• Support the Company’s contract management system and advise internal clients on contract policies and practices.
• Assist HR with in-house legal matters, including the revision of Employee Handbook, Company policies, and Employment Agreements.
• Support Corporate Strategy with advertising and promotional materials, including website content and social media posts.
• Collaborate with other legal team members on state licensing and government compliance efforts.
• Identify the need for and create new or improved contract templates for common transactions.
• Prepare and deliver training, written guidance, and other learning aids for employees.
• Work cross-functionally with internal teams to track and maintain legal updates on the Company’s pharmaceutical products portfolio.
• Develop innovative ways to communicate effectively with the organization to achieve compliance goals.
• Enhance legal department analytics and reporting capabilities.
• Provide support to General Counsel and other Counsel as needed.

Qualifications

• JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois.
• Minimum of 3 years of experience in a major law firm and/or the legal function of a major corporation.
• Practical experience in drafting and negotiating contractual agreements.
• Excellent analytical, drafting, negotiating, communication, and relational skills.
• Strong problem-solving, decision-making, and conceptual thinking skills.
• Ability to prioritize workload, manage projects, and meet strict deadlines.
• Knowledge of the pharmaceutical industry, including generics and biopharma, is preferred.
• Understanding FDA regulations and other laws impacting the pharmaceutical industry is a plus.

Education and/or Experience Required

Required:

•  JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois.
• Minimum of 3 years of experience in a major law firm and/o the legal function of a major corporation.
• Practical experience drafting and negotiating contractual agreements.

Preferred

• In house/corporate legal department experience.
• Working knowledge of life-science/pharmaceutical industry.
• Compliance and/or intellectual property experience.
• Knowledge and or experience litigating matters involving intellectual property.
• Understanding of FDA regulations and other laws impacting the pharmaceutical industry, including, the Anti-Kickback Statue, 340B, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, and communications with FDA.
• Experience with clinical trial agreements, ancillary service agreements, registry and observational study agreements, clinical vendor agreements, site management organization agreements, research collaboration agreements, and post approval study agreements.

AAP/EEO Statement

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

Summary

About Us:

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

Position Summary:

The Associate Director of Product Management for Meitheal's Generics 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 the execution of assigned new product launches, 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 include 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.

·       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

Education and/or Experience Required

Computer Skills

·       Extensive computer proficiency with desktop software in a Windows environment required: Microsoft Word; Excel; PowerPoint required. Tableau or similar Power BI experience required. 

·       Equal Opportunity Employer Minorities/Women/Veterans/Disabled. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

Apply Now:

If you are passionate about Product Management 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.

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

Job Summary:

Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. You will work closely with cross-functional teams within the Company and across business partners and play a critical role in the transformation and growth of regulatory teams to meet the needs of the company’s business growth toward biopharmaceuticals. 

Why Work with Us?

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

Essential Duties and Responsibilities

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

• Provide strategic regulatory guidance on combination products/devices to senior management and specific project teams. 
• Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout device and/or combination product development.
• Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
• Prepare and participate FDA meetings and EMA Scientific Advisory meetings for device/combination product development (generic products, innovative (505B2) products, and biosimilars) . Prepare and review regulatory submissions to FDA, EMA, and other regulatory agencies.
• Work with Head of Regulatory Affairs department to build up the competence and capacity for combination products 
• Provide support to CMC and regulatory sciences of complex generics, especially peptide generics, 505B2 NDA/innovative products, and biosimilars/biologics.

Supervisory Responsibilities

•  0 – 1 Direct Report

Competencies

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality 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. 

Education and/or Experience Required

• Bachelor, Master, or Ph.D. 's degree in life sciences. 
• 5 + years related experience in product development and/or regulatory affairs.
• Minimum of 3 years in combination product area. Or equivalent combination of education and experience. 
• Expertise in and experience with Regulatory Affairs of devices/drug-device combination products are 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.

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge).

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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. Recently, we've expanded into fertility biologics and biosimilars, and now market 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 Overview: We are seeking a visionary Director of Trade and Specialty Distribution to spearhead the distribution of our innovative Specialty products portfolio. This role is pivotal in establishing and maintaining strategic partnerships with national wholesale and specialty trade partners, ensuring the broad availability and adoption of Meitheal’s branded and biosimilar products. Reporting to the Sr. Vice President of Specialty Products, you will be responsible for identifying, evaluating, analyzing and recommending strategic channel approaches and effectively executing these strategies with Trade partners. 

Essential Duties and Responsibilities

• Forge and nurture strong relationships with key decision-makers among the Big Three and regional wholesalers, spanning full-line and specialty divisions.
• Lead negotiations with Trade partner accounts to expand access while preserving profitability.
• Ensure the availability of Meitheal products among retail chains.
• Collaborate with legal and contract management teams to execute competitive contract terms with distribution partners.
• Identify product-specific opportunities for distribution to and support of alternate sites of care.
• Analyze and report on sell-in and sell-out data to identify trends, obstacles, and opportunities.
• Resolve] Trade-related issues to reach successful resolutions.
• Identify value-added services that Trade partners provide, contributing to achieving brand marketing objectives and pipeline planning.
• Collaborate with Supply Chain, Brand, and Finance teams on current and future launch planning, return risks, GtN exposure, and other distribution-related impacts.
• Actively participate in key distribution conferences (e.g., HDMA, Asembia).

Supervisory Responsibilities

• This role begins as a single contributor role, though supervisory opportunities may arise with company expansion.

Competencies

• Resourcefulness
• Initiative
• Analytical skills
• Interpersonal skills
• Negotiation skills
• Teamwork
• Professionalism
• Judgment
• Ethics

Qualifications

• BS/BA required (science/business/finance); MS or MBA preferred.
• 15+ years in the pharmaceutical industry.
• 5+ years managing Trade customers, including experience with the Big Three wholesalers, representing branded products (biosimilar experience preferred).
• Proven track record in implementing strategic relationships, favorable pricing, and contracting terms for products among key customer segments.
• Prior launch experience of branded/biosimilar products.
• Specialty Pharmacy account management experience is a plus.

Skills:

• Strong negotiator and relationship builder.
• Demonstrated business acumen, analytical, and strategic thinking abilities.
• Ability to anticipate industry trends and ensure competitive positioning.
• Strong collaboration skills and experience influencing stakeholders to support strategic decisions.
• Strong understanding of Class of Trade FMV and trade terms that impact profitability.

Work Environment

Why Join Us?

• Be part of a forward-thinking pharmaceutical company making a tangible difference in patient access to essential medications.
• Collaborate with a passionate and dedicated team committed to our mission of accessibility and affordability.
• Drive the expansion of a diverse product portfolio in a dynamic and rapidly growing company.
• Enjoy a competitive salary and benefits package in a role that offers significant growth and development opportunities.

How to Apply: If you are a self-starting leader with a passion for advancing product access through strategic trade partnerships, we want to hear from you! Apply today to join the Meitheal team and contribute to our mission of fostering teamwork toward common goals.

AAP/EEO Statement

Meitheal Pharmaceuticals is an equal opportunity employer.

Summary

About Meitheal Pharmaceuticals

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a leading provider in the development and commercialization of generic injectables, fertility, biologics, and biosimilars. With a commitment to providing affordable and accessible healthcare solutions, Meitheal markets over 50 FDA-approved products across multiple therapeutic areas. Our mission is to work collaboratively towards a common goal, for the greater good. Ranked among the top 100 Crain’s Best Places to Work in Chicago, Meitheal embraces the guiding principle of Meitheal—working together towards a common goal.

Position Summary

The Regulatory Affairs CMC Manager / Sr. Manager is responsible for the on-time filing of high-quality regulatory submissions and for the post-approval maintenance of regulatory dossiers with an emphasis on CMC. This role provides regulatory guidance to team members, both internally and externally. The Manager / Senior Manager serves as the primary liaison regarding submissions and other relevant topics.

Essential Duties and Responsibilities

• Serve as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure business needs for the assigned products are met by anticipating, identifying, prioritizing, and mitigating regulatory risks while complying with all regulatory requirements.
• Develop and oversee the CMC regulatory strategy, preparation, and review of US FDA submissions, including original BLAs, 505B(2)/NDAs, ANDAs, amendments, supplements, annual reports, and labeling changes to BLAs, NDAs, and ANDAs.
• Individually perform and manage projects during all stages of the drug approval process to post-approval/life cycle management, collaborating with project management, business development, and legal to ensure the regulatory strategy aligns with corporate needs.
• Perform reviews of documentation from partners (domestic and international) for technical and regulatory compliance with minimal supervision.
• Approve manufacturing and labeling change controls, ensuring compliance with US regulations and guidelines.
• Train and mentor Regulatory Affairs associates on CMC product development and post-approval changes.
• Represent the Regulatory Affairs department in project development meetings and assist in developing regulatory strategies.
• Manage multiple projects within negotiated deadlines.
• Provide regulatory assessments to company (internal and partners) change controls and/or document changes based on ICH and FDA guidelines.

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.

• Adapt to changing environments.
• Ability to prioritize and multitask.
• Organized and detail oriented.
• Sense of urgency to meet all required deadlines.

Education and/or Experience Required

• Bachelor's degree in life sciences from a 4-year college or university; a minimum of 4 years related experience and/or training; or equivalent combination of education and experience.
• Experience in Pharmaceutical R&D and/or Manufacturing setting with some exposure to Regulatory Affairs is highly preferred. Experience with complex generics, drug-device combination products, biosimilars, or biologics is a plus!
• Strong written and communication skills.
• Experience communicating with global teams is preferred.
• Ability to handle multiple projects concurrently.

Computer Skills

• Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC), Regulatory publishing systems (DocuBridge), and Quality management systems (TrackWise).

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We encourage applications from 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

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

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

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

About Us: Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic and rapidly growing company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility biologics and biosimilars, Meitheal now markets over 50 FDA-approved products across various therapeutic areas. Our commitment to accessibility and affordability exemplifies the Irish principle of "Meitheal," which means fostering teamwork toward common goals.

Position Overview: Meitheal Pharmaceuticals is seeking an ambitious and highly motivated Sr. National Accounts Director to join our team. This role is critical in building and executing access strategies to expand Meitheal's market presence while advancing physician and patient access to our fast-growing portfolio. Reporting to the Sr. Vice President of Specialty Products, the Sr. National Accounts Director will be the primary liaison between Meitheal and national and regional PBM/Payer customers across commercial, Medicare, Medicaid, and other segments, with a core focus on Ascent/ESI and affiliated accounts.

Essential Duties and Responsibilities

• Collaborate with internal stakeholders to ensure alignment of pricing and contracting strategies with overall commercial objectives and brand strategy.
• Develop, implement, and refine payer opportunities and access strategies for key accounts to ensure profitable access and reimbursement.
• Identify opportunities beyond traditional payer channels to facilitate product growth.
• Build and leverage account relationships to secure access for current brands while preparing for future product launches.
• Develop strategic business plans for accounts and provide regular business updates and reviews.
• Utilize business acumen, industry knowledge, and financial modeling to create compelling proposals and negotiation strategies.
• Lead negotiations with payer partners to expand access while maintaining profitability.
• Monitor competitive pricing and contracting activities, proactively identifying opportunities and threats.
• Assist with contract implementation, including rebate payments and projections.
• Actively participate in major market access conferences (e.g., PCMA, AMCP, Asembia).

Supervisory Responsibilities

• This role starts as an individual contributor but may evolve into a supervisory position as the company expands.

Competencies

• Resourcefulness
• Initiative
• Analytical skills
• Interpersonal skills
• Negotiation skills
• Teamwork
• Professionalism
• Judgment
• Ethics

Qualifications

• BS/BA required (science/business/finance); MS or MBA preferred.
• 15+ years in the pharmaceutical industry.
• 10+ years in payer account management, payer reimbursement, payer marketing, or experience on the customer side.
• 5+ years of experience calling on national PBMs, preferably ESI/Ascent.
• Strong understanding of the US healthcare system, payer dynamics, access, and reimbursement.
• Proven leadership in market access strategy for pharmacy and medical benefit products.
• In-depth knowledge of commercial, Medicare, and Medicaid customer segments.
• Demonstrated business acumen, analytical prowess, and strategic thinking abilities.
• Ability to anticipate and address industry trends to ensure competitive positioning.
• Strong collaboration skills and experience influencing stakeholders to support strategic decisions.
• Understanding of the applicable legal and regulatory environment.
• Specialty Pharmacy experience is a plus.

Work Environment

Why Join Us?

• Be part of a forward-thinking pharmaceutical company making a significant impact on patient access to essential medications.
• Collaborate with a passionate team dedicated to our mission of accessibility and affordability.
• Drive the expansion of a diverse and innovative product portfolio in a dynamic and rapidly growing company.
• Enjoy a competitive salary and benefits package in a role that offers substantial growth and development opportunities.

How to Apply: If you are a self-starting leader with a passion for advancing product access through strategic payer partnerships, we want to hear from you! Apply today to join the Meitheal team and contribute to our mission of fostering teamwork toward common goals.

AAP/EEO Statement

Meitheal Pharmaceuticals is an equal opportunity employer.

Summary

About Us: Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all.

Position Overview: Meitheal Pharmaceuticals is searching for a highly motivated Sr. National Accounts Director to join our vibrant team. This role is crucial in devising and executing access strategies to broaden Meitheal's market footprint while enhancing physician and patient access to our rapidly expanding product portfolio. Reporting to the Sr. Vice President of Specialty Products, you will act as the primary liaison between Meitheal and national/regional PBM/Payer customers across commercial, Medicare, Medicaid, and other segments, focusing on Zinc/Caremark and affiliated accounts.

Essential Duties and Responsibilities

• Strategic Alignment: Work collaboratively with internal stakeholders to ensure pricing and contracting strategies align with overall commercial objectives and brand strategy.
• Payer Strategy Development: Develop, implement, and refine payer opportunities and access strategies for key accounts to ensure profitable access and reimbursement.
• Growth Opportunities: Identify opportunities beyond traditional payer channels to drive product growth.
• Relationship Building: Establish and leverage account relationships to secure immediate access for current brands while preparing for future product launches.
• Business Planning: Create strategic business plans for accounts and provide regular business updates and reviews.
• Proposal Development: Utilize business acumen, industry knowledge, and financial modeling to develop compelling proposals and negotiation strategies.
• Negotiations: Lead negotiations with payer accounts to expand access while maintaining profitability.
• Market Analysis: Monitor competitive pricing and contracting activities, proactively identifying opportunities and threats.
• Contract Implementation: Assist with the implementation of contracts, including rebate payments and projections.
• Compliance: Work compliantly with Medical Affairs/medical information to convey scientific and HEOR data to healthcare decision-makers.
• Conference Participation: Actively participate in major market access conferences (e.g., PCMA, AMCP, Asembia).

Supervisory Responsibilities

• This role starts as an individual contributor but may evolve into a supervisory position as the company expands.

Competencies

• Resourcefulness
• Initiative
• Analytical skills
• Interpersonal skills
• Negotiation skills
• Teamwork
• Professionalism
• Judgment
• Ethics

Qualifications

• Education: BS/BA required (science/business/finance); MS or MBA preferred.
• Experience: 15+ years in the pharmaceutical industry with 10+ years in payer account management, payer reimbursement, payer marketing, or experience on the customer side.
• Industry Knowledge: Strong understanding of the evolving US healthcare system, payer dynamics, access, and reimbursement.
• Leadership: Proven leadership in market access strategy for both pharmacy and medical benefit products.
• Market Insight: Demonstrated knowledge of commercial, Medicare, and Medicaid customer segments.
• Skills: Demonstrated business acumen, analytical prowess, and strategic thinking abilities.
• Vision: Ability to anticipate and address industry trends, ensuring competitive positioning.
• Collaboration: Strong collaboration skills and experience in influencing stakeholders to support strategic decisions.
• Regulatory Understanding: Understanding of the applicable legal and regulatory environment.
• Specialty Pharmacy: Experience in Specialty Pharmacy is a plus.

Work Environment

Why Join Us?

• Impactful Work: Contribute to a forward-thinking pharmaceutical company making a significant impact on patient access to essential medications.
• Collaborative Environment: Join a passionate team dedicated to our mission of accessibility and affordability.
• Growth Opportunities: Drive the expansion of a diverse and innovative product portfolio in a dynamic and rapidly growing company.
• Competitive Benefits: Enjoy a competitive salary and benefits package in a role that offers substantial growth and development opportunities.

How to Apply: If you are a self-starting leader with a passion for advancing product access through strategic payer partnerships, we want to hear from you! Apply today to join the Meitheal team and contribute to our mission of fostering teamwork toward common goals.

AAP/EEO Statement

Meitheal Pharmaceuticals is an equal opportunity employer.

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:

We are seeking a Sr. Associate of Labeling to join our Regulatory Affairs team. This role is essential in ensuring compliance with FDA regulations (21 CFR Part 201) and internal labeling policies. The successful candidate will support the Labeling function by creating and maintaining labeling documents, assessing processes for efficiency, and making strategic decisions regarding labeling content.

Essential Duties and Responsibilities

• Perform daily labeling functions, including drafting, revising, and responding to FDA deficiency letters.
• Create and maintain all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files.
• Make strategic and critical decisions regarding patents, carve-outs, and labeling content.
• Assess and improve labeling processes for efficiency.
• Format and develop labeling annotations and deficiency responses.
• Meet deadlines and goals in a timely manner.
• Proofread and annotate label copy to the highest quality standards.
• Document changes and justifications by developing and creating change controls.

Competencies

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

Qualifications

• Bachelor’s degree in life sciences from a 4-year college or university.
• Over 4 years of related experience and/or training, or an equivalent combination of education and experience.
• Proficiency in Adobe Systems (Pro, Acrobat DC, and Illustrator), Microsoft Office, DocuProof, Barcode Studio.
• Strong ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations.
• Effective communication skills, both written and verbal. Ability to write reports, business correspondence, and procedure manuals.
• Strong problem-solving skills and the ability to handle a variety of concrete variables in standard and non-standard situations.

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 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 labeling and regulatory affairs 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.