Careers

Summary

The Associate/Sr. Associate of Regulatory Affairs Chemistry, Manufacturing, and Controls  (CMC) position 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.  Works closely with Regulatory operations and Regulatory labeling team. 

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.
• Preparation and review of US FDA submissions, including original NDAs and ANDAs, and amendments, supplements, annual reports, labeling changes to NDAs and ANDAs.
• Reviews documentation from partners both domestic and international for technical and regulatory compliance.
• 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) and implements 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

• Bachelor's degree in life sciences from a 4-year college or university with some experience via training or internship in work related setting (Pharmaceutical R&D,  Manufacturing setting or Regulatory Affairs)

• Strong written and communication skills.

• Ability to handle multiple projects concurrently.

Computer Skills

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

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 Contract Coordinator will provide administrative assistance and support to the Contract Marketing and Marketing teams to include preparation and implementation of contracts and contract documents, review and maintenance of new customers, contract eligibility and the coordination of product materials. The Contract Coordinator will provide analytical assistance and support in the preparation and review of rebates and fees including providing documentation and support materials, as well as custom sales reports for Meitheal customers.

Essential Duties and Responsibilities

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

• Reviews and researches new customers in the iContracts system including updating customer naming conventions to Meitheal standards and the review and updates of the DEA/HIN/340B identifiers and Class of Trade (COT) assignments. Special emphasis on ensuring that verified and active 340B IDs are on any eligible PHS/340B and Apexus contract eligible members.

• Prepares contract documents for new product launches, price revisions, contract extensions, including price offers and contract amendments based on approved company templates.

• Prepares documentation and enters contract information, including fee and rebate programs into the iContracts system.

• Coordinates and aids in the preparation of new product launch information and materials for Meitheal wholesalers, distributor, and data bank customers.

• Prepares and maintains department contract files. Provides executed documents to Legal.

• Assists in the preparation and review of monthly/quarterly rebates and fees within the iContracts system and updates and maintains the rebate tracker. Provides customer fee and rebate sales reports per contract language.

• Prepares Authorized Distributor of Record (ADR) documents for Meitheal distributor customers. Maintains spreadsheet with ADR status. Prepares documents and reports for State Drug Price Transparency Programs, as required.

• Assists in the development of department policies and procedures for commercial operations activities.

• Processes and approves daily chargeback requests/credits including the review/verification of contract eligibility and pricing. Works directly with wholesalers/customers to resolve chargeback discrepancies.

Supervisory Responsibilities

None

Competencies

• Business Acumen

• Critical Thinking Skills

• Analytical Skills

• Communication

• Team Player

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 (Marketing or Business preferred) or 1-3 years relevant experience.
• Excellent communication and organizational skills.
• Word, Excel, and PowerPoint skills.
• Research skills using various databases to review customer information.
• Self-starter and detail oriented.

Education and/or Experience Required

• Bachelor’s degree (Marketing or Business preferred) or 1-3 years relevant experience.

Computer Skills

Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee must occasionally lift and/or move up to 25 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

AAP/EEO Statement: Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Director of Sales position is responsible for leading all aspects of the field sales organization to ensure corporate sales, revenue, gross margin and KPI goals are attained. The role requires effective leadership and focus to develop long term business partnerships within the key Integrated Delivery Networks (IDN’s) and Regional Key Customer(s) across the acute and non-acute markets. Being the liaison between the field sales team and corporate, the Director of Sales will coordinate communication on all aspects needed to drive sales forward ensuring both timely and appropriate level of detail.   

The Director of Sales will work closely with all Meitheal internal departments including National Accounts, Commercial Contracting, Marketing, Finance, Operations, Supply Chain, Quality, Legal and Human Resources to establish all foundational requirements of the sales organization, including defining annual department goals and key success factors to meet or exceed established goals.

Essential Duties and Responsibilities

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

• Plans, develops, and establishes policies and objectives of the Sales organization in accordance with organizational directives and with pertinent company leaders.

• Develops and administers the Meitheal Sales Programs to include the annual sales budget, quarterly MBOs and quotas.

• Supervises team weekly on goals and objectives progress and metrics towards overall performance achievement.

• Takes ownership in staff development.

• Ensures quarterly visit with Sales team and top customers are scheduled and effectively executed and follows up with executive leadership regarding key customer meetings.

• Works with Sales team to determine opportunities with customers and develops strategies with internal Meitheal team to gain product share and drive compliance through GPOs or individual agreements.  

• Works closely with internal team to provide updates on market intelligence with regards to pricing, trends and mergers.

• Works closely with Human Resources on employee issues and concerns in a timely manner. 

Supervisory Responsibilities

This role manages the field sales team. 

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. 

• Must understand relationship that IDN 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 Meitheal Pharmaceuticals at all levels within assigned IDN’s and Regional Key Customers.

Education and/or Experience 

• A four-year college degree.

• A minimum of 10 years’ experience within the pharmaceutical industry (generic preferred) required.

• Prior managing of healthcare (pharma or medical devices) sales organization with a deep knowledge of IDN or Regional Key Customer structure required. 

• Strong verbal and written communication skills with ability to effectivity present information to top customers both internal and external in group or individual settings. 

• Working knowledge of Generic Injectable Drugs and history of drug shortages required. 

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. 

• Must understand relationship that IDN 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 Meitheal Pharmaceuticals at all levels within assigned IDN’s and Regional Key Customers.

Education and/or Experience 

• A four-year college degree.

• A minimum of 10 years’ experience within the pharmaceutical industry (generic preferred) required.

• Prior managing of healthcare (pharma or medical devices) sales organization with a deep knowledge of IDN or Regional Key Customer structure required. 

• Strong verbal and written communication skills with ability to effectivity present information to top customers both internal and external in group or individual settings. 

• Working knowledge of Generic Injectable Drugs and history of drug shortages required.

Competencies

• Problem Solving

• Business Acumen

• Critical Thinking Skills

• Analytical Skills

• Results Driven

• Leadership

• Customer Focus

• Technical Capacity

Computer Skills

Microsoft Word, PowerPoint and Excel

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

This is a field-based role.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Director of Human Resources is responsible for developing policies and directing and coordinating human resources activities, such as employment, compensation, labor relations, benefits, training, and employee services. A strong emphasis for this role will be training and development and coaching managers and employees on various HR related matters in a fast paced growth organization. Successful candidates must have a track record of driving innovation through HR processes and creating effective change through strong project management and execution.

Essential Duties and Responsibilities

• Serves as a strategic partner to various departments, establishing HR business objectives that align with overall company plans and objectives.
• Assists with establishing company policies and communications around company policies, including employment opportunities, compensation, and employee benefits.
• Oversees the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization.
• Maintains cost-effective and market-competitive benefits programs; manages, researches and recommends changes to benefits programs and providers; engages in training and administering employee benefits programs.
• Coaches managers on performance management discussions, employee relations issues, discipline matters, and promotion/termination discussions.
• Identifies, analyzes, creates and facilitates training to employees at all levels on professional and personal development.
• Oversees HR processes including performance and compensation reviews.
• Identify and recommend in-house mentoring programs and workshops, and external/online training and education opportunities in order to further develop employees and management.
• Provide subject matter expertise on organizational effectiveness and change management; partnering with leaders to ensure that actions and plans enable the Meitheal culture to evolve as we rapidly grow the organization.
• Serves as a coach to both people managers and department leaders on employee engagement, performance management, development, skill development, rewards & recognition, employee relations, and leader effectiveness.
• Keeps current on external trends, developments, or activities that could impact talent, organizational effectiveness, culture, and leadership development.
• Partners with senior leadership to develop action plans to break down org silos and provide innovative talent solutions proactively to meet the changing demands of the organization.
• Manages and resolves Employee Relations (ER) issues through effective and objective investigation processes, ensuring adherence to appropriate employment laws and policies.
• Manages payroll and compensation packages through benchmarking analysis.
• Evaluate employee performance and manage performance review process.

Supervisory Responsibilities

This position will be responsible for managing one or more direct reports.

Competencies

• Problem Solving
• Interpersonal
• Oral Communication
• Managing People
• Motivation
• 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.

• Excellent communication and organizational skills.
• Self-starter and detail oriented in a fast-paced environment.
• Broad knowledge in change management, employment law, employee relations and training and development.
• Evidence of excellent communication – both written and verbal, with the ability to relate to employees and management at all levels.
• A genuine passion for working with employees and managers on solving problems.
• Demonstration of rapport that is both objective and welcoming.
• Demonstrated leader with the ability to independently handle projects and initiatives from start to finish
• Experience in the pharmaceutical industry or healthcare is a plus.

Education and/or Experience Required

• Bachelor's degree from four-year college or university; a Master’s degree or SHRM/PHR certification is value added.
• 10+ years of progressive HR experience across most/all areas of responsibility

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint), HR Software systems

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 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.

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.

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

The Sr. Director of Corporate Projects is responsible for managing key corporate initiatives. This role is vital in supporting the organization’s short-and-long term projects in a fast-paced and competitive environment. The Sr. Director of Corporate Projects collaborates cross-functionally with all departments and supports the CEO and Senior Management on key corporate projects. The Sr. Director is an integral member of the senior management team and performs high level executive and operational support, including those of a sensitive or confidential nature.

Essential Duties and Responsibilities

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

- Build credibility with business partners to gain support for project engagement and execution.

- Manage project inputs simultaneously from start to finish in a rapidly changing environment.

- Manage and maintain all high-level project deliverables.

- Own the creation and management of the project budget and planning, supervising the projects financially and contractually.

- Maintain effective and ongoing communication with all parties.

- A strong executive presence, excellent with interpersonal/communication skills.

- Candidate must possess strong strategic skills and data-driven approach to launch new activities and track and measure progress.

- Demonstrated record of organizational and management skills with high level of professionalism to engage C-suite and VP-level executives.

Supervisory Responsibilities

None at this time

Competencies

• Problem Solving

• Interpersonal

• Motivation

• Professionalism

• Critical Thinking Skills

• Project Management

• 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.

- A detail-oriented individual with 10 or more years of experience in a similar role.

- Personable, approachable, organized, resilient, and excellent with time management.

- A superb problem-solver who goes above and beyond to provide excellent service to employees while adhering to internal policies and procedures.

- Patient and open-minded, you take initiative, and you can juggle multiple tasks like a pro.

Education and/or Experience Required

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

• A minimum of 10 years of experience, preferably with generic pharmaceutical commercial experience.

• Strong people services leadership skills with focus on team building.

• Advanced level of expertise in Microsoft Word, PowerPoint, Excel, Adobe Professional, Outlook, and web-based applications are required.

• Up to 10% domestic and/or international travel

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

Sr. Manager, Project Management of drug development will provide project leadership and strategy for the Project Management function. The Sr. Manager, Project Management role will manage generic injectable pharmaceutical development portfolios of higher complexity and/or strategic importance to corporate strategy, including peptides, combination products and/or liposomal/nanoparticle products. The successful candidate will drive both internal and external cross-functional international teams to manage project milestones on time or ahead of schedule. Experience/knowledge in peptide, liposomal and/or combination product development is preferred.

Sr. Manager, Project Management will play a key role in the development and execution of the product development plans, ensuring that cross-functional teams are aligned on goals, technical strategy, timelines 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, as well as with Meitheal’s 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.

• Travel: 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.

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.