Careers

Summary

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

Essential Duties and Responsibilities

Responsibilities include the following. Other duties may be assigned.

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

Supervisory Responsibilities

None

Competencies

• Self-starter
• Strong problem-solving abilities
• Oral Communication
• Organizational skills
• Strategic Thinker, troubleshooting and mitigating risks
• Cost conscious
• Judgement

Qualifications

Qualifications

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

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

Education and/or Experience Required

Required

• Bachelor’s degree in Business, Supply Chain, Information Technology, or similar subject area
• 1-3 years of relevant experience

Preferred

• Work experience in pharmaceuticals and/or manufacturing environments
• Knowledge of the Drug Supply Chain Security Act (DSCSA) requirements
• Experience using TraceLink

Computer Skills

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

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.

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Controller, Vice president will serve as the organization’s senior accounting leader and is a key member of the Meitheal team supporting the Company’s high growth objectives, goals and strategies under the guidance of the CFO.  They will be responsible for leading the accounting function, month end close, audit, tax, risk management and optimizing related systems and processes. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

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

• Actively contributes to the evolution and execution of the organization's strategic and operational plans, by providing a dependable source of information to enable sound business decisions.  
• Enact plans to further automate financial systems and processes including, but is not limited to, financial reporting, order to cash, tax compliance and management reporting.    
• Responsible for overseeing and maintaining annual audit, tax and insurance compliance
• Partners with CEO to evaluate and implement US and ROW tax related considerations in support of Meitheal’s strategic growth plans.  
• Develops long-term trusted relationships with key external partners including auditors, tax consultants, and other financial advisors.
• Responsible for the overall month end close process including managing GTN and inventory reserves.
• Documents and explains impact of position papers related to technical accounting/tax issues
• Develops/maintains accounting policies, procedures, internal controls and tools to comply with U.S. GAAP.

Supervisory Responsibilities

This position manages all employees of the Accounting department and is responsible for the performance management and hiring of the employees within that department.

Competencies

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

• This individual must be self-motivated, results orientated, have the ability to organize/manage multiple tasks and be a critical thinker.
• Superior communication skills with the ability to communicate complex issues in a crisp, clear and concise way is ideal.
• Ability to identify problems, formulate solutions, influence others, and drive results are important leadership skills for this role.
• Technical experience establishing financial systems and infrastructure to enable scale.
• Understands ASC 606 and the impact on the company’s policies and procedures.
• This position requires up to 10% travel (may include minimal international travel). 

Education and/or Experience Required

Required:

• A bachelor’s degree in finance, accounting, or business with a minimum of 10+ years of related finance and accounting experience; C.P.A. is a must; 
• Experience in both private and publicly held international companies is preferred
• Minimum 4-6 years in public accounting firm, Big 4 preferred
• Solid understanding of U.S. GAAP, US Tax Compliance, and management reporting and analysis.

Highly Preferred:

• Previously held finance roles within the pharmaceutical industry

Computer Skills

Microsoft Word, PowerPoint and Excel. Technical software skills and experience: Experience establishing financial systems and infrastructure to enable scale. This includes ERP systems, Business Intelligence Tools, and experience optimizing data analytics to enact business decisions. 

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 20 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

The Biopharmaceutical Project Management position drives the scientifically advanced development, high-quality manufacturing processes, and complex clinical studies required to obtain FDA approvals to supply biosimilars and biological pharmaceuticals across Meitheal’s portfolio. This role manages program governance, provides program direction, and manages timelines and project controls across global functional teams, manufacturing/development sites and external service providers. The ideal candidate possesses strong and effective global project management, problem solving, and interpersonal skills and has a proven track record working cross-functionally across a wide variety of technical, business, and operational areas. Past experience in biosimilars, biologics and clinical trials preferred.

Essential Duties and Responsibilities

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

• Independently leads and manages cross-functional teams to develop strategies and project plans, including technical, regulatory, and clinical trials, risks and ensure timely completion of new biopharmaceutical projects in alignment with corporate goals.
• In cooperation with the global project team, defines project objectives, requirements, and assumptions necessary to structure a project or task related to biopharmaceutical product development, clinical trials, manufacturing and FDA submission/approval.
• Closely monitors/controls project progression to ensure projects are completed on schedule and within budget.
• Reports project progress to all key stakeholders. Liaison between project team and executive management.
• Supports the project teams to evaluate project challenges with necessary risk assessment, evaluates budget and timeline impact and implements corrective and/or mitigation.
• Prepares and manages project budget and milestones.
• Cultivates effective communication, cooperation, and trust within the global cross-functional and external teams
• Facilitates and leads effective project meetings.
• Up to 15% domestic and/or international travel.

Supervisory Responsibilities

Supervisory responsibilities including one or more direct reports.

Competencies

• Understanding of biosimilar and/or biologics CMC development, strategy, manufacturing, clinical trials and regulatory areas.
• Experience in planning and managing the global cross functional aspects of biopharmaceutical product development.
• Demonstrated knowledge and application of Project Management tools, such as Risk Management.
• A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

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.

• Demonstrated experience in biosimilar project management or related field.
• Detail focused with exceptional organizational skills.
• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

• Minimum of 5 years of relevant pharmaceutical or biotech industry experience in biosimilar development and/or biosimilar project management.
• BS Degree or equivalent experience in a related field.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint)

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 20 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

The HR Generalist position effectively coordinates and supports human resource operations. This position partners closely with HR Leadership and Accounting functions as an general HR ambassador/communication interface to employees and external partners. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following:

• Assists in the administration of benefit programs, including processing enrollments, changes and terminations and supports employees understanding of benefits; facilitates open enrollment.
• Processes required documentation through payroll and insurance providers to ensure accurate record keeping and proper deductions as well as review benefit statements.
• Records all PTO, Vacation and Sick time for employees and ensures accurate records are maintained.
• Processes bi-weekly payroll.
• Assist in 401(k) administration: process bi-weekly deferrals/safe harbor match. Records all PTO, Vacation and Sick time for employees and ensures accurate records are maintained.
• Administers post payroll and ad hoc reporting activities.
• Ensures compliance for the annual W2/ACA reporting process.
• Understands US - State tax filing requirements to ensure compliance through the payroll vendor
• Ensures compliance of all processes for HRIS and Payroll systems.
• Updates and maintains organizational charts and contact lists. Supports the performance review process, as needed.
• Drafts and/or sends employee communications and other HR related documentation.
• Assists in coordinating and conducting training on all HR technology, self-service portals, regulatory compliance topics and benefits as needed.
• Assists HR leadership in administering training; monitors all HR training programs to ensure training objectives are met.
• Supports the rolling out Company policies, programs and solutions.
• Supports and provides documentation timely to internal and external auditors; (Audits: Corporate, 401(k), HSA/FSA Non-discrimination testing, Workers Comp)
• Responsible for completing compliance reporting for EEO, ACA and Benefits.
• Supports the culture and goals of the Company.
• Assist with implementation of HR related systems.
• Maintains confidential and sensitive information involving employees and the Company.
• Other duties or projects as assigned.

Supervisory Responsibilities

None at this time

Competencies

• Agile

• Strategic Thinker

• Written and Verbal Communication Skills

• Problem Solving

• Interpersonal

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

• Possesses the following characteristics: customer service focused, proactive, flexible, approachable, courteous, tactful and diplomatic.
• Demonstrated skill proficiency in Microsoft Office.
• Excellent organizational skills, effective project management skills and commitment to meeting deadlines.
• Strong oral and written communication skills with an ability to work independently as well as within a group setting and can interface across multiple departments and levels of management.
• Self-motivated, detail oriented, takes the initiative and has the ability to work with general supervision.
• Must be circumspect in handling highly confidential and sensitive information.
• Understands and applies Meitheal values, maintains and demonstrates high ethical standards in conducting Meitheal’ s business.

Education and/or Experience Required

• Bachelor's degree in HR or related field required.
• 5+ years’ of progressive HR Generalist experience.
• 3+ years' of payroll processing and administration; multi-state.
• Broad knowledge in employment law, employee relations and training and development.
• Experience in the pharmaceutical industry or healthcare is a plus.

Computer Skills

Intermediate computer skills (including Microsoft Office)

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 20 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

The Major Account Executive will be responsible for developing long term business partnerships within an assigned territory that include(s) Integrated Delivery Networks (IDN’s) and Regional Key Customer(s) across both acute and non-acute markets for generic pharmaceuticals. This role reports to the Director of Sales and will work closely with the Company’s internal departments including National Accounts and Marketing to meet agreed upon goals. This is a field-based position and is preferred that candidates be located within the assigned geographical territory (Northeast).

Essential Duties and Responsibilities

• Responsible for gaining access at the highest level within the assigned IDN and Regional Key Customers to deliver the Company’s story and vision of partnership.

• Establishes and deepens relationships of key decision makers within assigned organizations.

• Identifies and drives opportunities with assigned customers, and develops strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements.

• Provides market intelligence to internal teams as requested.

• Conducts quarterly business reviews with customers to drive contract compliance, discover unmet opportunities and position the Company’s future products.

• Travel as required, to the Company’s corporate office in Chicago for meetings with commercial team.

• Other duties may be assigned.

Supervisory Responsibilities

None

Competencies

• Business Acumen

• Critical Thinking Skills

• Analytical Skills

• Communication

• Negotiating 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.

• High level of business acumen, analysis and judgement.

• Strong analytical skills and attention to detail.

• Must have prior experience selling and working with major IDN’s or Regional Key Customers.

• Knowledge of Generic Injectable Drugs and history of drug shortages required.

• Must understand relationship dynamics the assigned customer has with Group Purchase Organizations (GPO’s) and Wholesaler/Distributors and the types of contracts offered by both.

• Ability to effectively communicate and negotiate on behalf of the Company at all levels within assigned IDN’s and Regional Key Customer(s).

• Ideal candidate must have experience in selling and contracting current and future products at the health system level.

• This role requires up to 50% travel domestically.

Education and/or Experience Required

• Bachelor’s Degree in a business-related discipline.

• A minimum of 10 years of experience in pharmaceutical sales (generic injectables preferred).

• Experience in new molecule launches and pipeline analysis.

Language Skills

Microsoft Word, PowerPoint, Excel.

Work Environment

This role is field-based role.

Computer Skills

Microsoft Word, PowerPoint, Excel.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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 20 pounds.

Summary

The Major Account Executive will be responsible for developing long term business partnerships within an assigned territory that include(s) Integrated Delivery Networks (IDN’s) and Regional Key Customer(s) across both acute and non-acute markets for generic pharmaceuticals. This role reports to the Director of Sales and will work closely with the Company’s internal departments including National Accounts and Marketing to meet agreed upon goals. This is a field-based position and is preferred that candidates be located within the assigned geographical territory (Southeast).

Essential Duties and Responsibilities

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

• Responsible for gaining access at the highest level within the assigned IDN and Regional Key

 Customers to deliver the Company’s story and vision of partnership.                                                             

• Establishes and deepens relationships of key decision makers within assigned organizations.

• Identifies and drives opportunities with assigned customers, and develops strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements. 

• Provides market intelligence to internal teams as requested.

• Conducts quarterly business reviews with customers to drive contract compliance, discover unmet opportunities and position the Company’s future products.

• Travel as required, to the Company’s corporate office in Chicago for meetings with commercial team.

• Other duties may be assigned.

Supervisory Responsibilities

None

Competencies

• Business Acumen

• Critical Thinking Skills

• Analytical Skills

• Communication

• Negotiating 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.

• High level of business acumen, analysis and judgement.

• Strong analytical skills and attention to detail.

• Must have prior experience selling and working with major IDN’s or Regional Key Customers.

• Knowledge of Generic Injectable Drugs and history of drug shortages required.

• Must understand relationship dynamics the assigned customer has with Group Purchase Organizations (GPO’s) and Wholesaler/Distributors and the types of contracts offered by both.

• Ability to effectively communicate and negotiate on behalf of the Company at all levels within assigned IDN’s and Regional Key Customer(s).

• Ideal candidate must have experience in selling and contracting current and future products at the health system level.

• This role requires up to 50% travel domestically.

Computer Skills

Microsoft Word, PowerPoint, Excel.

Work Environment

This role is field-based role.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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 20 pounds. 

Education and/or Experience Required

• Bachelor’s Degree in a business-related discipline.

• A minimum of 10 years of experience in pharmaceutical sales (generic injectables preferred).

• Experience in new molecule launches and pipeline analysis.

Summary

The Product Launch Manager for Meitheal's Critical Care & Anesthesia portfolio is a high profile, highly collaborative role at Meitheal Pharmaceuticals. You will lead and own the new product launch process. From developing successful launch strategies in partnership with executive leadership to tactical execution, this role is pivotal to Meitheal's growth and success.  This is a Chicago-based hybrid role, in the office 2 days per week.

Essential Duties and Responsibilities

• Owns the new product launch process for assigned portfolios to ensure launch and post-launch success by providing support to all Meitheal departments including:

     o Leading global internal and external cross-functional product launch teams and facilitating the successful tactical execution of new product launches in the U.S. market.

     o Managing relationships with external partners and contractual obligations of related product programs.

     o Manages the post-approval process, providing cross-functional support to successfully implement product enhancements.

• Drives cross-functional communication and collaboration, identifying obstacles impacting launch timelines and developing recommendations to overcome launch challenges.
• Creates, implements, monitors and reports on the success of product launches, partnering with internal and external stakeholders.
• Organizes, schedules, and facilitates cross-functional team meetings to exchange information and drives corporate launch and supply goals, identifies risks, contingency plans, and ensures launch forecast is being met. 
• Actively managing and reporting project status, action plans and changes to launch timelines across the organization. Provides support and development of presentations to senior management and input for launch dates for forecasts and budget.
• Identifies opportunities for process improvements and driving cross-functional collaboration for successful implementation.

Supervisory Responsibilities

None

Competencies

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

Qualifications

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

• Working knowledge of regulatory, quality and labeling processes and manufacturing operations.
• 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.
• Experience working with cross-functional teams. 
• Ability to build positive working relationships and influence people, both internally and externally.

Education and/or Experience Required

Required:

• Bachelor’s Degree in a business-related discipline with at least four (4) years of increasing responsibility and experience in generic pharmaceutical industry, with preference towards project management and operations.
• A minimum of 3 to 5 years of experience in the pharmaceutical industry.

Preferred:

• Advanced degree (MBA/MS)
• Experience with global operating structures and project management

Computer Skills

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

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 20 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

The Product Manager, Critical Care & Anesthesia, provides operational leadership for short and long-term plans in real time for on-market products within Meitheal's Critical Care & Anesthesia portfolio. The Product Manager is a highly-motivated, creative and organized individual, a vital member of a team dedicated to operational execution of short-and long-term financial plans for product portfolio. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

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

• Develop and maintain an understanding of assigned product portfolio, including current and future market trends, customer mix and competitors. 

• Supports all annual and long-term planning through development of development of product budget and forecasts.  

• Develops recommendations and brings forward key decisions needed from Senior Management in support of short and long-term financial goals for product portfolio.

• Actively works with Finance and Pricing team to track financial performance and identify and recommend strategies to mitigate gaps and amplify successes.

• Provides pricing recommendations to help maximize product sales and gross profits.

• Identifies opportunities for increasing market share by assessing competitive landscape and patient needs.

• Monitors drug shortage landscape to identify, analyze and present potential new business opportunities.

• Partners with National Account and MAE to monitor contract compliance to help identify and drive increased volume compliance.

• Monitors product profitability and partners with various departments to identify and execute product cost improvement.

•Go-to person for national accounts, sales, trade relations and contract marketing for product information, product availability, sales collaterals, RFI completion and other internal data sources. 

•Works with manufacturing, supply chain, and customer service to ensure accurate and timely forecasting for new and existing products, including performing a monthly analysis versus budget and forecasts to manage variances.

•Participates in new product launch calls to support and provide commercial input for new launches.

•Partners with Director Product Management to provide support and development of presentations to senior management for creation and reporting of short and long-term financial plans.

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

• Experience with supporting sales channels.
• Ability to build positive working relationships.
• High level of business acumen, analysis and judgement.
• Solid understanding of sales, marketing or product management, preferably in healthcare industry.
• Strong analytical skills and attention to detail.
• Ability to work independently and make key-decisions.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Education and/or Experience Required

• Bachelor’s Degree in Business degree or BS/MS in life sciences with experience sales, marketing, product management.
• A minimum of 3 to 5 years of experience in the pharmaceutical industry.

Preferred

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

Computer Skills

Microsoft Word, PowerPoint, Excel, Project Management, Business Intelligence and Visualization tools (QlikSense, Tableau)

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 20 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

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 document or training management in a CGMP environment is a plus. This is a Chicago-based hybrid role, employees are in the office two days a week.  

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

Essential Duties and Responsibilities

• Responsible for Meitheal's Document Management Program vendors, and partners, as applicable, to meet review timelines.
• Responsible for Meitheal's Training Program for all departments.
• Supports Meitheal's Change Control Program as a back up, as necessary.
• Performs review and approval of QA documentation supporting New Product Launches and batch disposition, as necessary.
• Supports CAPA associated activities, as needed.
• Supports management during external inspections.
• Remains current in regulatory trends and requirements.
• Strong organization skills and attention to detail is a requirement.

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 accommodations 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 GLP as well as FDA trends and guidelines.

• Strong interpersonal skills and great attention to detail are necessary.

• 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.

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 accommodations 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 GLP as well as FDA trends and guidelines.

• Strong interpersonal skills and great attention to detail are necessary.

• 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.

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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Quality Assurance Specialist position’s primary responsibility is to perform Annual Product reviews and generate the report for each product on an annual basis. This will require review and analysis of associated manufacturing, analytical and Quality data summaries provided by partners to compile the report within the required timeline. Previous experience with review of Manufacturing, Analytical and/or Quality data in a CGMP environment is a plus. The position may also assist with intake and processing of Product Inquiries and Complaints, as needed. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

Essential duties and responsibilities may include the following but are not limited to:

• Works in collaboration with contract manufacturing partners to obtain necessary documents, to complete Annual Product reviews.
• Review and critique CGMP documents with respect to accuracy, completeness, and compliance.
• Prepares Annual product review reports for each product on an annual basis.
• Provides support to other areas in Quality department, including but not limited to, intake and processing of Product Inquiries and Complaints.
• Good writing skills and strong attention to detail is a requirement.

Supervisory Responsibilities

None currently.

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

• Good interpersonal skills and great attention to detail are necessary.
• Must be a team player with good problem solving and good verbal and written communication skills.
• Has strong planning and organization skills.

Education and/or Experience Required

• Bachelor’s in science or equivalent degree.  
• 2-5 years’ experience in Quality and/or Manufacturing with Pharmaceutical company or similarly regulated industry.
• Experience working in a cGMP production environment.

Computer Skills

·        Microsoft Word, PowerPoint, Excel 

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 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

The Senior Corporate Paralegal position supports the Legal Department in various commercial and corporate matters concerning the Company’s business and products, and prepares and coordinates procedural documents for general legal matters. This individual will be a key member of the Legal team utilizing in depth legal knowledge across a wide range of topics and business units to advise and support the organization on legal matters. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

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

• Assists with reviewing and revising various types of agreements in support of multiple business units and the Company’s pharmaceutical products, including, Purchase Agreements, Vendor & Service Contracts, Non-Disclosure Agreements, Statements of Work, Master Service Agreements, Licensing Agreements, Quality Agreements, and Pharmacovigilance Agreements
• Responsible for revising organizational charts, bylaws, and other corporate documents, as well as, preparing licensure and certification applications relative to distribution licenses working directly with the vendor
• Conducts legal and other general research on a wide range of regulatory, compliance, contractual and operational matters involving the business, including the relevant legislation, regulations, rules and guidance. 
• Assists with administrative and project related tasks as needed, including scheduling meetings, conferences, and follow-ups on legal matters.
• Assists with the development and implementation of Company policies and procedures
• Reviews Legal Billing with Outside Vendors
• Facilitates and supports the Company’s contract management system and its Contracts policies and practices and advises internal clients. 
• Coordinates and tracks all state licenses and licensing requirements and liases with commercial teams to ensure filings are up to date, including State Drug Price Transparency and Sunshine Act reporting obligations
• Works cross-functionally with other internal teams (Operations, Regulatory, etc.) to track and assist attorneys with providing patent and legal updates on the Company’s portfolio of pharmaceutical products. 
• Provides support and assistance on training including videos, written materials and graphic guides.
• Support ongoing compliance initiatives, including corrective actions, delivering training and execution of other strategic initiatives
• Support litigation management, as needed

Supervisory Responsibilities

None at this time

Competencies

• Business Acumen
• Critical Thinking Skills
• Analytical Skills
• Communication
• Negotiating 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.

• Excellent analytical, drafting, communication and relational skills
• Highest levels of integrity and professionalism
• Diplomatic, approachable, and possessing good business and personal judgment
• Knowledge of the pharmaceutical industry, preferably with generics
• Strong analytical, problem-solving, decision-making and conceptual thinking skills
• Ability to prioritize workload and self-manage projects, handle multiple tasks and meet strict deadlines
• Excellent administrative and organization skills
• Ability to operate well with a variety of personalities/capabilities in cross-functional teams, matrix environment
• This position may occasionally require travel domestically (up to 5%).

Education and/or Experience Required

Required:

• Bachelor’s degree and/or paralegal certificate

• Minimum of 7-10 years of experience in a mix of a major law firm or the legal function of a major corporation

• Practical experience drafting and negotiating legal agreements 

• Knowledge of document review/hosting databases; Practical Law, Microsoft Word; Outlook; Excel; and PowerPoint

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
• General understanding of employment law and policies and practices impacting the healthcare industry.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint)

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 20 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

The Vice President, Legal (Generics) role will be a dynamic, collaborative leader who will drive our legal team. This individual will provide commercial legal support on all contracts and transactional aspects of the Company's generics business and work closely with the Company's business teams to contribute to the Company's financial and operational success. This role reports to the General Counsel and will serve as a strategic partner accountable for anticipating and identifying legal and compliance risks in an evolving company.?

Essential Duties and Responsibilities

Acts as a direct legal advisor to all business units regarding corporate, commercial, compliance, transactional and contract matters impacting the generics business.

• Coordinates with Outside Counsel and the Company's Regulatory and Operations teams to develop patent strategies and recommendations for all generic products (development and pipeline) as well as assists with reviewing and advising on all patent related regulatory filings.
• Oversees compliance program and initiatives and participates in the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization, such as federal price reporting and state licensing and product transparency rules and regulations. 
• Anticipates and identifies legal issues and counsels stakeholders to develop legal strategies and solutions.
• Creates and delivers effective training and other presentations to stakeholders and other members of the department on legal topics and other relevant subjects.
• Drafts, reviews and negotiates various commercial agreements, including CDAs, 3rd party vendor agreements, service agreements, GPO, wholesaler and distribution agreements, in-licensing agreements, consulting/employment agreements, asset purchase agreements and other corporate agreements.
• Coordinates and assists in developing policies, procedures and systems to support the business and facilitates efficient contract development and analysis.
•  Supports the evaluation and due diligence process for company acquisitions and other partnerships, including human resource initiatives by researching, drafting and reviewing policies, procedures, handbooks and codes of conduct and participates in committees as needed to facilitate compliance initiatives such as benefits administration, etc.
•  Monitors the legal environment and trends concerning the generics business.
•  Develops and maintains contract templates, policies and procedures. 
•  Determines, implements and manages contract management tools and other technology adopted by the Legal Department; ensures the contract repository is accurate and up to date.
•  Generates reports, spreadsheets, memos and other documents for the Legal Department, and/or the senior management team.
•  Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest developments in corporate law and in other related areas; provides updates on changes in legal and regulatory developments affecting the pharmaceutical industry, coordinating with other leaders in the Legal function as may be appropriate. 
• Manages legal expenses consistent with budget for legal matters.
• Establishes strong partnership relationships with internal teams, as well as key cross functional teams.
• Supervises legal work of other attorneys, paralegals, and outside counsel; consults on difficult or sensitive issues.
• Supports the General Counsel on legal projects and initiatives as needed. 

Supervisory Responsibilities

This role anticipates one or more direct reports.

Competencies

• Business Acumen
• Critical Thinking Skills
• Analytical Skills
• Communication
• Negotiating 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. 

•  Excellent analytical, drafting, negotiating, communication and relational skills.
• Highest levels of integrity and professionalism.
• Diplomatic, approachable, and possessing good business and personal judgment.
• Knowledge of the generics pharmaceutical industry, including compliance related aspects.
• Strong analytical, problem-solving, decision-making and conceptual thinking skills.
• Highly developed interpersonal and communicative skills to interact effectively with stakeholders both internal and external.
• Ability to prioritize workload and self-manage projects, handle multiple tasks and meet strict deadlines. 
• Working knowledge of Paragraph IV Challenges and Hatch Waxman Litigation. 
• Enthusiasm and "self-starter" qualities, enabling management of responsibilities with an appropriate sense of urgency; the ability to function effectively and efficiently in a fast-paced and dynamic environment.

Education and/or Experience Required

•  JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois.
•  Minimum of 12-15 years of progressively responsible corporate and or commercial legal experience, including significant experience reviewing, drafting and negotiating contracts as well as management responsibilities.

Preferred

• In house/corporate legal department experience with extensive knowledge of healthcare law.

• Compliance and/or intellectual property experience in a highly regulated environment.

• Experience implementing contracts processes and technology solutions.

Language Skills

N/A

Computer Skills

Microsoft Word, PowerPoint, Excel

Physical Demands

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.

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.