Careers

Summary

The Associate Counsel position will be responsible for supporting the Legal Department in various commercial and corporate matters, which covers a broad spectrum of assistance to Sales and National Accounts, Marketing, Regulatory, Quality, Operations and Human Resources.  This role will report to the General Counsel or other Senior Counsel.

Essential Duties and Responsibilities

• Reviews, drafts & negotiates various types of agreements in support of multiple business units, including, Service Contracts, Vendor Contracts, Non-Disclosure Agreements, Statement of Work, Master Service Agreements, Licensing Agreements Quality Agreements, and Pharmacovigilance Agreements
• Analyzes and provides legal guidance on a wide range of regulatory, contractual and operational matters, including the interpretation and implementation of legislation, regulations, rules and guidance
• Supports the Company’s contract management system and its Contracts policies and practices and advise internal clients on them
• Assists the HR department with any in house legal matters, including revision and review of Employee Handbook and Company policies and plans, as well as Employment Agreements
• Proactively identifies the need for, and assists with the creation of, new or improved contract templates for common transactions
• Proactively identifies the need for, prepare, and deliver training, written guidance and other aids for employees
• Work cross-functionally with other internal teams (Operations, Regulatory, etc.) to track and maintain relevant legal updates on the Company’s portfolio of pharmaceutical products,
• Provides support and assistance on training including video, written materials and graphic guides
• Develops innovative ways to communicate effectively with the organization to achieve compliance goals
• Supports efforts for value creation by legal department
• Supports and enhances legal department analytics and reporting capabilities
• Provide support and assistance to General Counsel and Corporate Counsel, as needed
• 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.

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

Education and/or Experience Required

Required:

• JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois
• Minimum of 3 years of experience in a mix of a major law firm or the legal function of a major corporation
• Practical experience drafting and negotiating legal agreements 

Preferred:

• In house/corporate legal department experience
• Working knowledge of life-science/pharmaceutical industry
• Compliance and/or intellectual property experience
• Knowledge and or experience litigating matters involving intellectual property
• Understanding of FDA regulations and other laws impacting the pharmaceutical industry, including, the Anti-Kickback Statue, 340B, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, and communications with FDA
• Experience with clinical trial agreements, ancillary service agreements, registry and observational study agreements, clinical vendor agreements, site management organization agreements, research collaboration agreements, and post approval study agreements

Computer Skills

Microsoft Word, PowerPoint, Excel.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit. 

Work Environment

The noise level in the work environment is usually moderate.This position may occasionally require travel domestically (up to 5%).

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Associate Director, Clinical Operations leads clinical operations programs, providing vision, management, and daily execution. Program goals, milestones and deliverables are achieved via a close interaction and collaboration with all functional lines involved in clinical development. This position provides operational leadership and successful execution of clinical trials according to regulatory guidelines, oversight of timelines, budgets, resources, clinical trial sites, vendors and key project deliverables. In addition, this position strives for continuous improvement of department infrastructure through the development of SOPs, guidelines and the use of technology; facilitation of effective internal and external relationships, and achievement of project goals and objectives.   This role will report directly to the VP of Clinical Development or the Sr Dir. of Clinical Development.

Essential Duties and Responsibilities

• Contributes to strategic planning to ensure optimized clinical development plans for assigned projects in alignment with company goals. 
• Ensures operational feasibility of clinical development plans and scenarios, including development of, and management to, timeline, budget and resource requirements.
• Ensures all study activities are completed in accordance with country specific GCP/ICH requirements and guidelines, health authority regulations and SOPs.
• Drives clinical research activity including resourcing, staffing, and direction and action plans with investigational sites, CRAs, and CROs.
• Develops, reviews, implements and maintains standards across clinical studies within a program including but not limited to new hire training for SMs/CRAs/PERs, tools, templates and CRO manuals.
• Determines patient recruitment strategies, operational feasibility and implementation of study/program objectives.
• Provides assessment of outsourcing requisites and options to determine appropriate outsourcing selection at the study, program, and corporate levels.
• Guides study team in vendor selection; managing vendors throughout the life of all assigned clinical projects.
• Proposes vendors to senior management for approval.
• Coordinates the preparation and finalization of IND submissions, investigator brochure updates, DSURs, NDA submissions (and/or country-specific equivalents)
• Provides technical expertise for the development of clinical documents, including prioritizing, authoring, and approving study activities (i.e. protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
• Develops the infrastructure to support advanced clinical trials .
• Coordinates closely with all internal stakeholders to ensure operational excellence. 
• Identifies and communicates with therapeutic thought leaders for feedback on study protocols, development plans, publications, etc.
• Manages relationships with corporate partners on studies/programs, as applicable, for clinical operations.
• 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

• Expert and comprehensive understanding of country specific pharmaceutical standards, FDA, GCP/ICH requirements (and/or equivalents), principles, concepts, industry practices, and standards, as well as a thorough understanding of cross-functional clinical processes including medical, data management, biostatistics, medical writing, pharmacovigilance, and regulatory.
• Thorough knowledge of data management, data review and analysis, drug safety and pharmacovigilance activities.
• Effective communication and interpersonal skills, with the ability to successfully articulate strategies, experimental results and analysis to various constituents such as governance committees, project teams, clinical sub-teams, and senior management to build enthusiasm and commitment, and to gain approval/sponsorship for projects.
• Responds effectively to inquiries or complaints. 
• Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well.
• Self-motivated, independent, and results-oriented.
• Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.
• Exceptional attention to details.

Education and/or Experience Required

• BA/BS in life science or healthcare field
• 10+ years of progressive clinical operations experience in pharmaceutical/drug development, with a preference for antibody/biologics experience, and including 8 years of experience in study/program management
• Proven track record of planning, conducting & managing clinical operations for Phase 1-3 studies
• Proven track record of evaluating, selecting, budgeting, directing and managing CROs, central laboratories, and other clinical study vendors
• Experience managing the clinical operations for drug across multiple therapeutic areas is a plus
• Expertise in the areas of drug development, operations and strategic planning; experienced with submissions from investigational new drug through new drug application filings and managing pre-clinical through all clinical phases 
• International experience is highly preferred
• Track record of leading a cross-functional team in a matrix environment
• Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done)
• Experience in a hands-on early development role within a small organization is a plus
• Demonstrated ability to handle a high volume of highly complex tasks within a given timeline

Physical Demands

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 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 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.