Careers

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

Marketing Director, Women's Fertility (WF) leads the marketing strategy and tactics of the WF brand and portfolio products. This highly motivated individual is creative, with strong communication and project management skills, who collaborates effectively with internal and external stakeholders. The Marketing Director leads the design and implementation of the marketing/commercial plan to achieve product sales and market share expectations. 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 lead the implementation of the marketing plan(s) for the WF portfolio.

• Build and manage the marketing budget.

• Set sales volume and market share forecasts.

• Conduct pricing analyses and provide recommendations.

• Collaborate on direct and indirect contracting strategies with Trade and National Account teams.

• Develop and manage print/digital promotional materials for internal and external stakeholders.

• Manage vendor relationships, ensuring quality and timely deliverables.

• Lead Meitheal's presence at relevant medical society meetings.

• Manage relationships with patient advocacy organizations.

• Build effective relationships with key opinion leaders (KOLs) in the relevant disease/treatment area(s)

• Provide input to senior management on life cycle management and business development opportunities.

• Adhere to all internal and external legal and regulatory guidelines.

Supervisory Responsibilities

None at this time

Competencies

• Project Management

• Cross-functional leadership

• Business Acumen

• Judgement

• Change Management

• Ethics

• Interpersonal communication

Qualifications

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

• Experience supporting multi-partner alliances and collaborations e.g. GPOs, IDNs, Specialty Pharmacy. etc.

• Strong relationship building skills, with demonstrated ability to collaborate and operate across functions (e.g. Legal, Regulatory, Sales, Trade, etc.).

• Product launch and brand/portfolio management experience.

• Solid understanding of biotech/pharmaceuticals, production forecasting, program and/or alliance management.

• Ability to source, evaluate and manage multiple vendor relationships.

• Manage multiple projects in a timely and cost-efficient manner.

• Ability to work both independently and collaboratively in a fast-paced environment.

• Excellent planning, presentation, communication, organization and time management skills.

• Up to 25% domestic travel.

Education and/or Experience Required

• Bachelor’s Degree in business or BS/MS in life sciences.

• 7 or more years of experience in the biotech/pharma industry with marketing, new product planning, product launch and/or sales roles.

• Prior experience marketing generic injectables and/or biosimilars is strongly preferred.

• Prior experience marketing women's fertility products is strongly preferred.

• Understanding of OPDP and OIG regulations.

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 10 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

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 Manager of Supply Chain is responsible for ensuring the inbound delivery of inventory from global suppliers, and outbound customer sales orders are executed successfully. This role will manage relationships with 3^rd party logistics providers (3PL), customs brokers, and freight forwarders. Individual will also 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

• Performs integrated supply chain duties associated with, but not limited to, production planning, transportation planning, and inventory management.
• Interacts with various cross-functional teams to provide support and ensure timely completion of tasks in alignment with corporate goals and new product launches.
• Manages inbound freight planning and execution with global suppliers, including reconciling freight spend and invoices.
• Manages new product launches with product setup at 3PL, freight forwarder(s), customs broker, and government agencies.
• Manages product returns with internal sales team and with the 3PL provider.
• Creates purchase orders, reconciles receipts and opens balances.
• Prepares inventory, transportation, and sales reports.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

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

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.

• Familiarity with international transportation and logistics processes and best practices and ability to manage door to door international transportation projects.
• Detail focused with exceptional organizational skills.
• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

Required

• Bachelor’s degree from four-year university
• 3-5 years of Supply Chain experience
• Skilled at troubleshooting and mitigating risks for multiple projects at a time to meet corporate goals

Preferred

• Degree in Supply Chain related field
• Supply Chain experience in the pharmaceutical industry

Computer Skills

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

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

Product Manager, Critical Care & Anesthesia, provides operational leadership across a number of programs and collaborations with partners and external parties in relation to new product lines within Meitheal's Critical and Anesthesia portfolio. The Product Manager is a highly-motivated, creative and organized project manager/business alliance manager to be a vital member of a team dedicated to managing program plans and budgets for the new Meitheal business initiatives. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

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

• Functions as the primary point of contact for alliance teams on the status of all program-related issues, both ongoing and potential, as appropriate.
• Supports activities including but not limited to kick-off meetings, joint team meetings, quarterly updates, executive briefings
• Ensures timely and complete capture of meeting minutes, including key actions, issues, mitigation plans, and decisions.
• Ensures the ongoing alignment of project team goals and objectives by creating and maintaining high level timelines, entering updates to the plan and tracking activities to ensure alignment with target dates.
• Engages with the alliance partners on the various day-to-day issues and opportunities arising from the collaborations.
• Manages and evaluates financial and technical trade-off analyses required for proposed changes in a project.
• Supports all long-term planning through commercial forecasts and budget activities. Contribute to resource planning, financial and capacity assessments
• Develops recommendations and brings forward key decisions needed from Senior Management in support of project and business objectives.
• Ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
• For all assigned projects, proactively identify and resolve conflicts as needed. Anticipate potential risks or delays, act to minimize them and develop backup strategies
• Identify opportunities for process improvements and collaborate to implement them
• Up to 15% domestic and/or international travel

Supervisory Responsibilities

None

Competencies

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

Qualifications

• Experience with supporting multi-partner alliances and collaborations.
• Ability to build positive working relationships.
• High level of business acumen, analysis and judgement.
• Solid understanding of biotech/pharmaceuticals, production forecasting, program and/or alliance management
• 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 a business-related discipline with at least four years of increasing responsibility and experience in generic pharmaceutical industry, with preference towards product management, portfolio management or marketing.

Preferred

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

Computer Skills

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

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

Sr. Associate/Manager of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. This position provides regulatory guidance to team members, internally and externally and acts as the primary liaison with regulatory agencies, primarily the FDA, as it relates to product submissions and other relevant topics. Works closely with Regulatory operations and Regulatory labeling team. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

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

• 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 being in compliance with all regulatory requirements. 
• Develops and oversees the CMC regulatory strategy; prepares and reviews US FDA submissions, including original NDAs and ANDAs, and amendments, supplements, annual reports, and labeling changes to NDAs and ANDAs. 
• Negotiates with FDA during all stages of the drug approval process to post approval/life cycle management, collaborating with project management, business development and legal to ensure regulatory strategy is in-line with corporate needs.
• Reviews documentation from partners both domestic and international for technical and regulatory compliance.  
• Approves manufacturing and labeling change controls, ensuring US regulations and guidelines are satisfied.
• Represents  the Regulatory Affairs department in project development meetings and assists in the development of regulatory strategies.
• Provides regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.

Supervisory Responsibilities

None

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 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

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: 

• Bachelor's degree in life sciences from a 4-year college or university; a minimum of 4-5 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. 
• Strong written and communication skills.
• Experience communicating with global teams is preferred.     
• Ability to handle multiple projects concurrently.

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.  

Computer Skills

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

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

Sr. Manager, Project and Alliance Management will provide project leadership and strategy for the Project and Alliance Management functions.  

The Sr. Manager, Project and Alliance Management role will manage internal generic injectable pharmaceutical development projects and external/international alliance projects of higher complexity and/or strategic importance to corporate strategy. Projects include, but are not limited to peptides, combination products, liposomal/nanoparticle products and biologics. The successful candidate will drive both internal and external cross-functional international teams to manage project milestones, tasks, budgets and risks. Experience/knowledge in peptide, liposomal and/or combination product development and/or alliance management is preferred.

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

Essential Duties and Responsibilities

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

• Planning and execution of projects in support of Research and Development (R&D) and business objectives.

• Supports generic drug development for U.S. market by work in a highly cross-functional internal environment, with external international drug development and manufacturing partners.

• Facilitates cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership.

• Independently manages all development projects to meet exhibit batch and submission goals.

• Executes frequent international project team calls, issue agendas, notes and conduct all follow ups.

• Directs and manages all project team activities to resolve technical issues and to ensure all project goals and timelines are achieved by interacting with key stakeholders across divisions and influencing others internally and externally to complete their assigned tasks on schedule.

• Assesses project risk and supports mitigation planning and follow up.

• Generates and publishes monthly project status reports and other reports as needed.

• Up to 15% domestic and/or international travel.

Supervisory Responsibilities

None at this time

Competencies

• Self-starter

• Strong problem-solving abilities

• Oral Communication 

• Organizational skills

• Strategic Thinker, troubleshooting and mitigating risks

• Cost conscious

• Judgement

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 managing multiple pharmaceutical projects within the product development process.

• Detail focused with exceptional organizational skills.  

• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

Required:

• B.S. in pharmacology, chemistry or related discipline.

• 5-8 years of Pharmaceutical experience.

• 5 or more years of experience in product development and/or project management in pharmaceutical drug development.

• Skilled at troubleshooting and mitigating risks for multiple projects at a time to meet corporate goals. 

Preferred:

• Solid technical knowledge in injectable pharmaceutical product development.

• Fluency in Mandarin

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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.

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 Talent Acquisition Partner supports the talent acquisition efforts of the Company by implementing effective recruiting and staffing strategies to attract a diverse pool of qualified and capable talent for the organization.

Supervisory Responsibilities

N/A

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following (other duties may be assigned):

• Consults with hiring managers to understand the requirements, duties and qualifications desired for the specified vacant positions.

• Develops, implements and manages efficient and effective recruiting strategies, both personally and through vendors, against delivery of Time, Cost and Quality targets and metrics.

• Coordinates interviews, overseeing preparation of interview questions and other hiring and selection materials, educating stakeholders on interviewing techniques and assessing and evaluating applicants.

• Facilitates candidate travel, as needed, in accordance with company policies and guidelines.

• Coordinates on-boarding efforts and orientations for new employees, including I-9 verification and background screenings, staying on top of legal and industry specific trends and requirements.

• Supports company recruiting policies that promote diversity and equality.

• Owns the job posting and advertising processes and insures inclusive language in all hiring material.

• Checks candidates references and credentials, verifying experience and backgrounds.

• Counsels candidates on the interview and hiring process and appropriately challenges the recruitment process to ensure hiring activities have the appropriate priority and top candidate considerations in mind to ensure a mix of skills, abilities, potential and diversity.

• Drafts job descriptions and company communications regarding recruiting efforts and participates in Town Hall Meetings promoting recruitment efforts.

• Collaborates with the hiring manager during the offer process, identifying and recommending salary ranges, incentives, start dates and other pertinent details consistent with years of experience and budgetary constraints.

• Conducts new hire orientation and quarterly check ins as part of the onboarding process.

• Supports the culture and mission and vision of the Company.

• Ensures all new hire documentation and Company policies are executed and retained.

• Maintains confidential and sensitive information involving employees, candidates and the Company.

• Attends and participates in job fairs and recruiting sessions as well as training as needed to keep up to date on recruiting and benefit trends.

• Supports HR Projects, including performance management, benefits administration and training initiatives and vendor relationships as capacity allows.

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.

• Possesses 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.

• Understands and applies Meitheal values, maintains and demonstrates high ethical standards in conducting Meitheal’ s business.

Education and/or Experience Required

• Associate degree in HR related field required (Bachelor’s preferred) or equivalent HR experience.

• 3-5 years’ experience in human resources, including experience with Recruiting.

• Broad knowledge in change management, 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