Careers

Summary

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

Essential Duties and Responsibilities

• Supports the implementation of necessary Regulatory publishing systems, including assistance with validations, qualifications and verifications of the systems.
• Supports the preparation and implementation of Publishing Operations processes and standards.
• In collaboration with the publishing operations lead, publishes high quality submissions and ensure all components meet eCTD format requirements.
• Development and Implementation of a File Transfer system, FTP Server.
• Performance of high level formatting in both word and PDF files, including creating bookmarks, hyperlinks, file optimization, optical character recognition, etc.
• Reviews submissions for compliance with technical requirements. 
• Submits eCTD submissions through the ESG FDA gateway.  
• Inputs information about submissions into internal databases/systems per internal requirements and procedures.
• Develops and maintain understanding of relevant regulatory requirements for US submissions.
• Timely and effective support and troubleshooting of the Electronic Submission System.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

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

Qualifications

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

• Assimilate to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated. 
• Have a sense of urgency to meet all required deadlines.

Education and/or Experience Required

Bachelor's degree in life sciences/IT from a 4-year college or university; over 2 years related experience and/or training; or equivalent combination of education and experience.

Computer Skills

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

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 Computer Systems Validation (CSV) Manager is responsible for writing and executing compliance documents (Validation Master Plan (VMP), qualification protocols, risk assessments, test scripts, specifications, reports, etc.) and procedures suitable for validation of GMP related computer systems. The responsibilities for this position include ensuring that the systems are performing in accordance with their specified requirements and validated in accordance with FDA and other agency requirements. This position is also responsible for System Administration activities for Meitheal’s Serialization System.

Essential Duties and Responsibilities

• Serves as project leader for all aspects of validation/qualification for computer system validations.
• Authors and executes Computer System Validation deliverables, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's, Change Control Documentation, and Risk Assessment reports.
• Manages and coordinates all aspects of computer systems validation activities, including project planning, developing validation strategies, document development and document reviews.
• Reviews vendor generated validation documentation to determine suitability and alignment with company CSV SOPs and GAMP 5.
• Maintains expertise in current and emerging cGMP requirements and quality trends (21 CFR Part 210, 211, 820 and Part 11).
• Manages the release updates for all GMP related computer systems.
• Handles change requests associated with Computer System Validation activities.
• Collaborates with system users to develop risk assessment for computer systems.
• Collaborates with the Process Owners to determine, and document, appropriate user requirements.
• Participates in the development, implementation, and modification of Computer System Validation Standard Operating Procedures (SOP) and Information Technology (IT) GxP procedures based on current regulations and industry standards.
• Works with QA to resolve any discrepancies or issues encountered during the validation of a computer system.
• Perform periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the system(s). 
• Ensures appropriate remediation plans are identified for gaps identified during the periodic reviews.
• Acts as subject matter expert for CSV during regulatory inspections.
• Collaborates with QA to monitor audit observations related to GXP computerized system and computer system validation to ensure gaps are identified and adequately addressed.
• Participates in periodic audits of Software Vendors.
• Other duties may be assigned.

Supervisory Responsibilities

None

Competencies

• Analytical Skills
• Strong Communication Skills (Verbal and Written)
• Problem solver
• Priority Setting
• Strategic Thinker
• Time Management

Qualifications

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

• Assimilates to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated. 
• Has a sense of urgency to meet all required deadlines.

Education and/or Experience Required

• Degree (bachelor’s or Masters) in Computer Science, Software Engineering or other relevant Science Field.
• Five (5) to ten (10) years in a cGMP-related industry preferred with at least 5 years of Computer System Validation or IT Operations experience working with cGMP pharmaceutical regulated industries and 21 CFR Part 11 compliance.
• Validating a serialization or track & trace project is highly advantageous
• Previous experience in writing, reviewing and executing computer validation documentation (VMP, IQ, OQ, PQ, VSR).
• Thorough understanding of the principles of computer systems validation, IT GxP, and testing best practice.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part 11 and industry best practices.
• Ability to understand existing and new business processes and requirements, to ensure proper implementation and validation of systems.
• Experience with SaaS systems in GxP environment preferred.

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC). Beneficial experience with Serialization systems (Tracelink), TrackWise/TrackWise Digital, SAP, Docubridge.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is occasionally required to stand; walk 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 Contract Coordinator will provide administrative assistance and support to the Contract Marketing team at Meitheal for a variety of commercial operations and tasks including the preparation and implementation of contracts and contract documents, the review and maintenance of new customers and contract eligibility and the coordination of product materials, spreadsheets and on-line registration for new product launches. Also, the 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

• 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. Involves researching on-line databases and Group Purchasing Organization (GPO) member files and portals.
• 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, distributors, and data bank customers, as required.
• Prepares and maintains department contract files including SharePoint, Shared Commercial Operations folder, business intelligence reporting and file maintenance, Major Account Executive (MAE) pricing tool, distributor pricing models, Qlik and hard copy files. Provides executed contract documents to Legal.
• Assists in the preparation and review of monthly and quarterly rebates and fees within the iContracts system; update and maintain the rebate tracker. Provides customer fee and rebate sales reports.
• Prepares Authorized Distributor of Record (ADR) documents for Meitheal distributor customers, as required. Maintains spreadsheet with ADR status.
• Assists in the preparation of Price Review Committee meeting minutes, presentation material and processing of approved PRC action items.
• Assists in the development of department policies and procedures for commercial operations activities.
• Additional ad hoc support and analysis for team as required.
• Other duties may be assigned.

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. 

Education and/or Experience Required

• 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.

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 noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Quality Assurance Specialist works closely with Regulatory Affairs and Meitheal partners to ensure Meitheal’s standards and requirements are met and in accordance with FDA requirements for external and labeling change controls. Proactively supports the existing quality systems including batch disposition activities, training, standard operating procedures, and data management activities in association with the company’s management review and annual product quality review processes.

Essential Duties and Responsibilities

• Supports the day to day management of the change control process for Meitheal’s external and labeling change controls including:

1. Initiating the process for external changes performed by Meitheal’s partners within Meitheal’s TrackWise system.
2. Reviewing supporting documentation provided by Meitheal’s partners for external change controls.
3. Tracking external change controls throughout change control process to ensure on time closure or extension.
4. Reviewing and performing QA approval of labeling change controls.
5. Fielding questions on change control process from Meitheal team members.

• Performs review and approval of QA documentation for all Meitheal batch disposition activities, including:

1. Batch Record review per the applicable review frequency.
2. Review of COA, COC, and Quality documentation supporting shipment authorization of product manufactured for Meitheal prior to shipment.
3. Review of Partner’s investigations for adequate root cause analysis.
4. Review of temperature profiling data.

• Provides guidance and support in all aspects of cGMP to our Partners including good documentation practices and root cause analysis during investigations.
• Provides ongoing support to the existing Quality Management System and training programs.
• Supports management during external inspections.
• Remains current in regulatory trends and requirements.
• Other duties may be assigned.

Supervisory Responsibilities

None currently.

Competencies

• Code of Federal Regulations and cGMP’s
• Strong written and oral communications skills
• Planning and Organizing
• Interpersonal
• Team Work
• 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. 

Education and/or Experience Required

• BS in life science or equivalent degree. 
• 3-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry.
• Background in aseptic processing, preferably with injectables.
• In-depth 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 strong 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.
• Elevates issues to management, when appropriate.

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 noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Sr. Manager Clinical Development Process Improvements/Project Management is responsible for developing GCP/ICH related processes and SOPS by which Clinical Development will operate, support training internally and externally for teams as necessary, and track one or more complex projects conducted by cross-functional therapeutic teams. This is critical role in building out and managing the function toward operational excellence. It is a supportive role for any project team developing compounds in the areas of immunology, inflammation, and possibly oncologic diseases. This role reports directly to the VP, Clinical Development. 

Essential Duties and Responsibilities

• Works closely with the VP, Clinical Development to assist in management of development program(s) including planning, execution, and reporting on projects and milestones.
• Works closely with the VP, Clinical Development and Technical Writer to develop necessary functional SOPs according to GCP/ICH.
• Manages and leads process project teams work plans and deliverables.
• Collaborates with the VP Clinical Development, Alliance Manager and CRO PMs to prepare project / product updates for governance meetings and to clearly communicate status in written documents and presentations.
• Oversees and manages the effective coordination and facilitation of cross-functional team meetings from a program management perspective supporting Clinical Operations team leads.
• Collaborates with Clinical Operations leads activities to create, organize and maintains plans and timelines needed toward defined objectives of projects, across clinical and nonclinical projects.
• Assists in development of new processes (SOPs) and training as required internally in partnership with CROs, and project teams, including training and educational materials teams would like to use for patient recruitment/engagement.
• Performs project management-related tracking to ensure milestones are met and deliverables achieved.
• Coordinates with various teams to analyze project results and performance, track key issues, ensure timely and adequate resolution, budgets/contracts management for clinical studies.
• Coordinates activities with external vendors, where applicable; track achieving contracted deliverables.
• Contributes to team effectiveness.
• Supports management of the cross functional team space in SharePoint or other appropriate shared portal site.
• Supports clinical team in tracking of deliverables to the project budget for each assigned project, with function leadership and team leader to ensure delivery within governance approved limits.
• Other duties may be assigned.

Supervisory Responsibilities

No direct reports anticipated at this time.

Competencies

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.

Qualifications

• Experience with Clinical Research Sites and CROs
• Experience with GCP/ICH guidelines and SOP/training development
• Strong interpersonal, negotiation, and active listening skills
• Distinguishes proper balance between strategic and tactical thinking
• Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Strong verbal and written communication skills; ability to clearly and effectively present information
• Must be able to work under minimal and at times no supervision, determine personal work plan, and schedule tasks and activities.

Education and/or Experience Required

• Bachelor’s degree in life sciences or business and at least 4+ years in Biotechnology, Pharmaceutical, or other Healthcare related field
• 5+ years of experience in a Drug Development/Clinical Project team role either supporting a Development function (e.g. Clinical Operations or Regulatory Affairs) or Medical Affairs or Clinical Development Project sub-teams

Physical Demands

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 Senior Manager of Account will work within the Finance function with a series of responsibilities, including leading the month end accounting process, as well as technical accounting and reporting responsibilities for the organization.

Essential Duties and Responsibilities

• Overseeing the technical accounting function, including adoption of new Accounting standard pronouncements.
• Drafting/maintaining new accounting disclosures to comply with the newly issued accounting standards.
• Preparing and maintaining accounting documentation, including technical accounting research on complex accounting issues and document the position papers.
• Developing/maintaining accounting policies, procedures and tools/templates to comply with GAAP.
• Implementing changes in accounting policies, procedures and system changes.
• Coordinating with independent auditors for interim and annual audit.
• Reviewing contracts to determine the accounting impact including the new ASC 606 impact.
• Developing, implementing and reviewing documentation for internal control compliance and testing.
• Working closely with internal and external auditors throughout the implementation process and after adoption to ensure audit requests are provided in a timely manner.
• Establishing gross to net process for accounting for daily shipments as well as the monthly reconciliation.
• Implementing gross to net process into ERP system (SAP Business One).
• Creating cash flow statement monthly and developed short term and long term cash flow based on wholesaler balances.
• Analyzing AR issues and actively monitor the cash application process of 3PL (ICS).
• Preparing/reviewing journal entry and reconciliations.
• Establishing accruals/reserves (including chargebacks, prompt pay discounts, product returns etc.).
• Preparing corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast.
• Reviewing results on a monthly basis and provide variance analysis.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

To perform this job successfully, an individual must be able to focus on the overall objective for a given process or accounting area, while at the same time able to dive into transactional detail if needed to resolve questions or issues. Must have a curious mindset that proactively seeks understanding and feedback.

Qualifications

• US GAAP and technical accounting research experience.
• Financial Statement Analysis experience.
• Pharma industry experience including generics and brand highly preferred, including experience with gross to net adjustments, and chargebacks.
• CPA preferred.  

Education and/or Experience Required

• Bachelor's degree in Accounting or Finance.
• Minimum of 7 years of experience with a mixture of public accounting (Big Four or large regional firm preferred) and industry experience that includes technical accounting or reporting responsibilities.

Language Skills

One must display excellent communication skills; able to quickly establish a personal brand within the organization to drive cross functional collaboration.

Computer Skills

Solid understanding of U.S. GAAP, SEC financial reporting, and management reporting and analysis.

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; and sit. 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 Staff Accountant position supports the Company’s high growth objectives, goals and strategies under the guidance of the Controller. The Staff Accountant position supports the month end close process, performs accounts receivable (including gross to net adjustments) and other projects as needed. 

Essential Duties and Responsibilities

• Assists in month end close process, including revenue, inventory, fixed assets, prepaids and supply chain accounting, reconciliation and analysis.
• Analyzes, processes and resolves chargebacks items to establish appropriate credit within the contractual requirements through extensive research of EDI submissions to resolve discrepancies between wholesaler requests for credit and the Meitheal chargeback system.
• Performs corporate accounts payable and accounts receivable functions. 
• Reviews results on a monthly basis and provides variance analysis.
• Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers.
• Independently and timely performs non-recurring, one-off projects and other analyses as delegated by the Controller.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

• Business Acumen
• Positive Attitude
• Business/Financial Acumen
• Ethics and Values
• Motivation
• Critical Thinker
• Team Player
• Strong Analytical Skills
• Technologically Proficient
• 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.

• Ability to utilize advanced finance and accounting experience to manage assigned workload.
• Working knowledge of corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast.
• Able to quickly establish a personal brand within the organization to drive cross functional collaboration.
• Curious mindset that proactively seeks understanding and feedback.

Language Skills

Excellent communication skills.

Education and/or Experience Required

• Bachelor’s degree in Accounting, Finance or related area is required.
• Minimum of 1-3 years of experience with Pharmaceutical industry experience preferred.  
• Solid understanding of U.S. GAAP and management reporting and analysis.

Computer Skills

Microsoft Word, PowerPoint, Excel.

Physical Demands

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

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.