9-06 Pharmaceutical industry opportunities

Leading pharmaceutical firms seek key people:

Director - Drug Safety
*** relocation assistance is available ***

Oversee the adherence of all relevant corporate and FDA requirements pertaining to the receipt, entry, tracking, evaluation, and reporting of adverse events and serious adverse events resulting from Phase I-IV internal studies in ad-hoc reports and other sources for marketed products. To provide direction and manage staff responsible for the collection, processing, medical review and evaluation, analysis, and reporting of all safety related information. To provide strategic input to the organization regarding pharmacovigilance and risk management.

Responsible for the department and its overall function within the organization. Interact as necessary, with various internal departments and participate in global efforts to achieve synergies worldwide to accomplish the basic functions of this position.. Domestic/international travel may be required for business approximately 15%.

RESPONSIBILITIES
As the Drug Safety Officer (DSO) for USA
* Has final responsibility for the adequate and timely reporting of Serious/Adverse Events (S/AEs) and medical complaints from the territory to Global Safety (DSD) and from DSD to the local authority.
* Acts as liaison between the health professionals, consumers, FDA and DSD.
* Has responsibility for all contacts with health professionals, health authorities, and consumers in USA regarding adverse event and medical complaint reporting and safety (related) issues.
* Ensures adequate classification of product surveillance data into technical complaints, medical complaints, and customer feedback, and exchange of relevant safety information with Technical Complaint Officer.
* Writes specific local procedures for handling S/AEs and/or Medical Complaints.
* Provides relevant training on Adverse Events (AEs) and Medical Complaints reporting requirements to appropriate personnel within the company

As the Director, US DSD,
has final responsibility for corporate USA compliance and adherence to approved procedures and relevant FDA regulations, requirements, and timelines.
*Oversee and direct staff to ensure appropriate handling of receipt, tracking, processing, evaluation, analysis, and reporting of all serious and non-serious adverse events for clinical and marketed products.
*Oversee the production of required periodic adverse drug experience reports for clinical and marketed products.
*Reviews the safety-related portions of US package inserts and other documents slated for submission to the FDA.
*Interacts with Regulatory Affairs Department regarding the safety aspects of reports produced for registration purposes.
*Participates in clinical trial teams and investigator meetings, assists with preparation of protocols and informed consents, and writes subject narratives for the trial reports in cooperation with Global Medical Safety Advisor.

Develops, implements, tracks and manages department budget.

Ensures strong working relationships between department personnel and Clinical Development, Clinical Trial Operations,
Regulatory, and Medical Affairs personnel, as well as with the Global Drug Safety Organization.

Develops and mentors staff; assess the internal and external resources requirements in order to meet project objectives.

Conducts staff meetings every four to six weeks to provide information and recognition which effectively supports and motivates staff to achieve Departmental and Company objectives.

Reviews performance appraisals to monitor the quality of the work evaluation and oversee development plans to completion.
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Contract Manager, Managed Care Contracts

Responsible for all aspects of pharmaceutical contract analysis, development and implementation, with oversight responsibilities of contract administration.

Works as part of a team of managers and analysts in the MCO, PBM, Trade or Chargeback contracting teams. These teams, headed by a Senior Manager, work closely with their US Managed Markets sales force counterparts and, where necessary, directly with customers, to negotiate and execute discount agreements for pharmaceutical products.

Will coordinate the work of several areas and departments and develop recommendations for the approval of corporate management.

Primary responsibility for developing financial analysis for customer discount proposals and for the development of financial forecasts for their accounts.

Will frequently be called upon to complete special analysis for management or the product marketing teams and to participate as part of multi-function teams to develop pricing or discounting strategy for products. Will gain experience in several of the contracting teams to gain an understanding of all areas of pharmaceutical discount contracting.

RESPONSIBILITIES
Responsible for the following activities in addition to supporting general Global Pharmaceutical Business functions:

1. Contract Management
Primary responsibility for the development and execution of Discount Agreements.
• Work in conjunction with the field sales forces, product management teams, Law Department and other areas of finance to develop contract and pricing strategies;
• Develop detailed account proposals for management review and approval describing the financial and related aspects of all discount proposals;
• Prepare contracts and amendments for review by the customer;
• Review contracts and amendments accepted by the customer and execute agreements on behalf of the Corporation; and
• Work with the Rebate Administration department to analyze rebate claims submitted by managed care organizations for adherence to contractual terms and approval by finance management. The information gathered from rebate claims is also analyzed for trends in utilization of pharmaceuticals.

Currently, the company has over 80 discount agreements with various organizations and these agreements require constant maintenance for changes in market conditions or corporate policies or procedures.

A key aspect of the position is in the area of Contract performance assessment.
Will take the lead in evaluating the performance of corporate discount agreements and providing analysis and recommendations to the Global Marketing teams and Finance Management on changes and improvements.
Will be expected to constantly find new ways to improve the financial performance of the company’s discount agreements.

2. Sales and Discount Planning and Forecasting
The US managed markets are highly regulated and controlled and represent the majority of the company's sales and discounts. The company’s agreements and financial analysis are subject to review by a number of Federal agencies, are a key component of Sarbanes-Oxley reporting, and are used as the basis for the development of estimates used in the company’s financial statements. Because of the sensitivity of these agreements and their resulting impact on operations, rebate and sales estimates are generated for each market segment and for each customer.

Responsible for developing in year estimates of financial performance as well as forecasts for future years for each of their customers and for presenting this information for review by Finance, Marketing and US Managed Markets Management.
Responsible for coordinating this analysis with their teams, the Department and other areas of finance to develop discount rate estimates and rebate liability forecasts for the company.

3. Analysis of Product Contracting Opportunities
Expected to understand the company’s pharmaceutical product efficacy and safety profiles as well as current marketing strategies to be able to analyze current managed care market dynamics and recognize opportunities for new or revised contracting strategies.
Will be engaged either formally or informally in multi-departmental teams or efforts to devise ways to enhance product performance.

4. Systems Enhancements
Will provide aid to IT and the involved consultants in evaluating current applicable systems and aiding the development of scope and function assessments for new systems.
As a primary user of many components of the new systems, will also be expected to take part in user testing and evaluation as the new systems come on line.
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Sr. Contract Analyst

Supports the Federal and Specialty (hospital, GPO, Specialty Pharmacies, and State Prisons) Markets.

Responsible for contract analysis and development for corporate Federal, GPO, Hospital and Specialty Pharmacy Contracts.

Works as part of the Federal and Specialty Markets contracting Team, which works closely with their US Managed Markets sales force counterparts and, where necessary, directly with customers, to negotiate and execute discount agreements for pharmaceutical products.

Has primary responsibility for developing financial analysis for customer discount proposals and for formal review of chargebacks or rebate claims that have been processed by the Administration teams.

May be called upon to complete special analysis for management or the product marketing teams and to participate as part of multi-function teams to develop pricing or discounting strategy.

Will be called upon to support financial and contract analyses associated with Federal, GPO/Hospital and Specialty Pharmacy portfolio. With a new Alliance with a leading firm, our formidable presence is the Federal Markets, and products in the pipeline, this includes some of the company’s most important and publicly visible primary care and specialty pharmaceutical products.

RESPONSIBILITIES

Responsible for the following activities in addition to supporting general Global Pharmaceutical Business functions:

1. GPO, Hospital and Specialty Pharmacy Contract Analysis

Has primary responsibility for the development of financial analysis for proposed, and the review of current, GPO, Hospital and Specialty Pharmacy Discount Agreements

• Work in conjunction with the field sales forces, product management teams, Law Department and other areas of finance to develop financial forecasts for proposed GPO/Hospital and Specialty Pharmacy discount agreements;
• Aid in the development of detailed account proposals for management review and approval describing the financial and related aspects of all discount proposals; and
• Work with the Chargeback and Rebate Administration teams to analyze chargebacks and rebate claims submitted by Hospitals and Specialty Pharmacies for adherence to contractual terms. The information gathered from chargeback and rebate claims is also analyzed for trends in utilization of the company's pharmaceuticals and to aid in the development of new marketing and contracting strategies.

Currently, the company has over 50 discount agreements with GPOs, Hospitals and Specialty Pharmacies and these agreements require constant maintenance for changes in market conditions or corporate policies or procedures.

key aspect - in the area of contract performance assessment.
Will help to evaluate the performance of the company’s GPO, Hospital and Specialty Pharmacy discount agreements and provide analysis and recommendations to the Global Marketing teams and Finance Management on changes and improvements. It is expected that the Contract Analyst will be able to continually find ways to improve the financial performance of the company’s discount agreements.

2. Federal Government Contracting (Department of Defense and Department of Veterans Affairs)

Responsible for aiding all Government planning and reporting involving the company’s contracts with the Departments of Veterans Affairs and Defense. Sales to these Federal Agencies are governed by a complex series of laws and regulations that carry severe penalties for non-compliance. It will be the job of the Senior Contract Analyst to complete the array of reporting requirements, anticipate future reporting necessities and potential liabilities. In this area, the primary responsibilities are:

a) Executing all Federal Supply Schedule pricing modifications including Most Favored Customer Analyses, Temporary Price Reductions and annual Federal Ceiling Price calculations.

b) Maintaining the relevant internal and competitor price lists for use with Federal contracting and compliance.
Monitoring all Tracking Customer pricing to ensure that the Federal Government is getting the appropriate price.

c) Assisting the Business Units and Managed Care and Military Field Forces on Federal pricing and
contracting strategies. The Senior Analyst will aid in developing contracting strategies and supporting financial analyses for Federal issues within the company Laboratories.

3. Sales and Discount Planning and Forecasting

Aids in the development of in year estimates of financial performance as well as forecasts for future years for Federal, GPO, hospital and Specialty Pharmacy discount agreement.

4. Analysis of Product Contracting Opportunities

Understand the pharmaceutical product efficacy and safety profiles as well as current marketing strategies to be able to analyze market dynamics and recognize opportunities for new or revised contracting strategies.

5. Data Analytics

A key goal for the US Managed Markets Finance group is to continually improve analyses and financial forecasts.
Will develop new tools and enhance current ones that give corporate management the best possible insight into potential outcomes of proposed discount agreements. This will likely involve financial modeling and scenario derivations sophisticated enough to capture the many dynamics of the Federal, GPO/Hospital and Specialty Pharmacy markets but presented such that they can be quickly and easily incorporated into a decision tool for management.
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IMPORTANT NOTE :
Please specify which positions are of interest to you.
Due to the high volume of response, only candidates who appear to have the proper qualifications will be contacted - thank you.

Director - Drug Safety

MD or PharmD with Board Certification preferred.
* Minimum ten (10) years relevant experience, with three to five (3-5) years in the pharmaceutical industry, including experience in the evaluation of safety information from clinical trials, and for marketed pharmaceutical products.
* Demonstrated supervisory experience, particularly in a senior management capacity.
* Knowledge of FDA regulations, GCPs, and ICH guidelines relevant to drug safety.
* Ability to interact with all levels of personnel within, and external to, the company, including internationally.
* Flexibility to travel internationally and/or domestically for business purposes: approximately 15%.

salary: 150 - 180k + 20% target bonus

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Contract Manager, Managed Care Contracts

Education
Bachelor of Science Skills A Bachelor’s degree is required for this position (preferably in Accounting, Finance or Economics), a master’s degree preferred.

Should have at least 5-10 years of business experience with 3-5 years in the Managed Care and/or Pharmaceuticals preferred.
• Knowledge of managed care and/or pharmaceutical contracting
• Demonstrated attention to details and ability to perform complicated, intricate work accurately
• Confirmed ability to manage multiple tasks and meet deadlines

salary: 80 - 100k + 10% target bonus

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Sr. Contract Analyst

A Bachelor’s degree is required for this position (preferably in Accounting, Finance or Economics)

Should have at least 3-6 years of business experience with experience in the Managed Care and/or Pharmaceutical industries preferred.

Advanced knowledge of managed care and/or pharmaceutical contracting, preferably with knowledge of the GPO/Hospital and Federal markets

Thorough knowledge of the chargeback operations process

salary: 80 - 100k + 10% target bonus

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IMPORTANT NOTE :
Please specify which positions are of interest to you.
Due to the high volume of response, only candidates who appear to have the proper qualifications will be contacted - thank you.