Careers

Summary

The Associate/Senior Associate of Labeling position is responsible for providing effective support to the Labeling function in Regulatory Affairs, in compliance with the FDA regulations, 21 CFR Part 201 and internal labeling policies and/or procedures.

Essential Duties and Responsibilities

• Performs daily labeling functions in Regulatory Affairs which includes: creation of draft labeling, revision of current labels and/or FDA deficiency letters.
• Creates and maintains all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files to ensure accurate rendering for all products.
• Makes strategic decisions regarding patents, carve-outs and labeling content.
• Assesses labeling processes and practices for efficiency and continual improvement.
• Format/develops labeling annotations and deficiency responses.
• Meet deadlines and goals in a timely manner.
• Proofreading and annotating label copy to the highest of quality standards.
• Ability to document changes and justification by developing and creating change controls.
• Other duties may be assigned.

Supervisory Responsibilities

None

Competencies

• Planning and Organizing
• Communication
• Team Work
• 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.

Education and/or Experience Required

• Bachelor's degree in life sciences from a 4-year college or university or 4 years related experience and/or training; or equivalent combination of education and experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. 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 Sr. Associate of Regulatory Affairs 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

• 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.
• Other duties may be assigned.

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.

Education and/or Experience Required

• Bachelor's degree in life sciences from a 4-year college or university; a minimum of 2 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.

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 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 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 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.  Loads contract documents in internal contract document management system.
• 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.   Prepares documents and reports for State Drug Price Transparency programs, as required.
• 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 Pricing Analyst for Meitheal Pharmaceuticals Inc. (“Meitheal”) will be responsible for providing analytical support related to all aspects of commercial pricing and contract activities at Meitheal. The Pricing Analyst will focus on providing direct day-to-day operational and tactical support to Contract Marketing. Additional support will be provided cross-functionally (Marketing, Sales, National Accounts, Finance) to aid in meeting annual sales and profit goals.

Candidates should be comfortable and confident challenging assumptions within a business model, have experience working with large amounts of unstructured data and be a self-starter who enjoys performing meaningful analysis that informs and drives business decisions. 

Essential Duties and Responsibilities

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

• Recommends pricing actions by analyzing and interpreting data, and supporting recommendations with detailed analyses (i.e. market competitive trends, customer specific trending).
• Supports Contract Marketing  in the management of Meitheal’s weekly Price Review Committee (i.e., supports analysis development, prepares agenda and visual aids, distributes meeting minutes, etc.).
• Acts as single point of contact for price and profitability analysis and aggregation of information supporting completion for major GPO bid opportunities. 
• Anticipates the impact of pricing and business decisions while weighing multiple factors and reviews as appropriate with management.
• Develops price and profitability templates to analyze and interpret multiple data points.
• Coordinates the quarterly review of 340B price calculations.
• Supports Meitheal’s financial forecasting, budgeting, and long-term planning process.
• Manages contract compliance reporting, rebate calculations, and ITS claim analysis.
•  Maintains knowledge and stays abreast of pricing developments in the industry via information obtained from publicly available sources, including financial publications, government agencies, company sources, and personal interviews; compiles and collects such information and provides feedback to the team as appropriate.
• Works closely with Sales and National Accounts teams to provide analytical support, reporting, and answer inquiries on a regular basis.
• Helps manage product listings and information required for customer online interfaces.

 

Supervisory Responsibilities

None currently.

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

• BS in Marketing, Finance or Business Administration required.
• 1-3 years of related experience required, with pharmaceutical industry experience preferred.
• Outstanding analytical skills with high attention to detail.
• Excellent interpersonal skills and ability to work effectively in a team environment.
• Strong written and oral communication skills.

Computer Skills

Must have advanced skills in Microsoft Excel with proficiency in other Microsoft Office suite applications preferred (Word, Powerpoint, Access). Experience with Qlik Sense or other business intelligence software a plus.

 

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. 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 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.