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Senior Clinical Outsourcing Manager Resume

Woodcliff Lake, NJ

CAREER SUMMARY:

Over 20 years of pharmaceutical experience in auditing, regulatory affairs, managed care, analytics, organizational leadership, sales, marketing, government pricing strategy, contract processing negotiations, manufacturing/drug development processing, and clinical research. Over 5 years of training and development experience in the pharmaceutical and educational industry.

COMPUTER SKILLS:

Proficient in: Microsoft Office applications, Microsoft Project, Authorware Professional 3.0, Toolbook, Photoshop, Freelance, Ofoto, Director 4.0, C Language, I - Many.

PROFESSIONAL HISTORY:

Confidential, Woodcliff Lake, NJ

SENIOR CLINICAL OUTSOURCING MANAGER

Responsibilities:

  • Direct the utilization of Contract Research Organizations (CROs), Central Labs and Specialty Providers to assure the delivery of quality, timely and cost - effective external resources to support the Development pipeline.
  • Lead projects, working groups, initiatives to ensure Clinical Contracting (CC) is prepared to successfully respond to the changing needs & requirements - legal, operational, risk management, regulatory & financial - of our internal & external customers, worldwide. 10%-35% savings.
  • Negotiate contract terms, scope of work, pricing and payment schedules, ensuring that the agreements with the ESPs are commercially advantageous to company, while minimizing regulatory, legal, and financial risks through close collaboration with functional partner such as legal, Finance, QA, and functional lines.
  • Produce final contracts/amendments and secure all necessary company approvals including SOX compliance to facilitate execution of said agreements

Confidential, Raleigh, NC

PURCHASING SPECIALIST

Responsibilities:

  • Pre-Clinical and Early-Phase Services works with company's Clinical Pharmacology and Drug Dynamics (CPDD), Toxicology, Pharmacology, Legal, and Corporate Procurement teams, as well as with multiple other company organizations, vendors and subsidiaries.
  • Ensure that supplier relationship and performance management structures are in place. Develop and foster relationships with Pre-Clinical and Early-Phase teams from both company and our suppliers to ensure clear communication, create an environment of partnership, and agree-to contractually committed levels of service, quality, delivery, and cost.
  • Prepare, finalize, and distribute requests for proposal to R&D services suppliers with a team of internal company stakeholders. Negotiate master services, confidentiality, statements of work, and other supplier agreements based on developed templates and with the support of pre-clinical, early phase, and legal teams .

Confidential, New York, NY

CLINICAL PROCUREMENT MANAGER

Responsibilities:

  • Global Lead and support the scope and commercial aspects of procurement for drug projects, managing a portfolio of external partners and providers.
  • Global Costs benefit analysis and contract development on planned acquisitions for studies with commercial vendors, sites, IVRS, IT license agreements and CROs.
  • Lead regional cross-functional teams and participate in evaluation and selection of external vendors aligned to the clinical strategy, using recognized criteria, such contract development, budget analysis, audits and supplier management measures.

Confidential, Southfield, MI

PROJECT MANGER

Responsibilities:

  • Manage the 4,000+ T1 orders that are being processed through the Confidential & Confidential work center. Responsible for tracking and updating spreadsheets. SharePoint knowledge.
  • Notification to the retail store of when CT& Confidential (Circuit Turnup and Test) will be scheduled.
  • Data entry and budget tracking of project targeted Confidential $2.5 million.
  • Maintain high level of organization, communication and project timeline to senior and VP level of management.

Confidential, Raleigh, NC

GLOBAL OPERATIONS SPECIALIST

Responsibilities:

  • Review and negotiate US and international budgets building to ensure fair market value.
  • Prepare and execute on US/International confidentially disclosure agreements, when applicable.
  • Liaise with the paralegal to obtain internal legal review and input on Clinical Study Agreements and Confidential Disclosure Agreements and intellectual property (IP) agreements.
  • Follow clinical guidelines as it relates FAR requirements.
  • Participate in the negotiation of agreements directly with US investigators and facilitates in the contract process in phase III and IV and pre-clinical research.
  • Track study milestones (enrollment and study progress) and issue payments to US investigators or advise MSD to initiate payments for their local investigators upon achievement of milestones.
  • Understands and remains current with the requirements of External Studies GDP (Gross Domestic Product) and related tools, all applicable laws, regulations, and developments affecting the investigator-Initiated Studies Program.
  • Support the financial management of Investigator-Initiated Studies Program by developing and maintaining a direct working relationship with the Global Research Specialists, MRL Financial Specialist Adm., paralegals, finance departments, MSD subsidiary offices and external customers.
  • Manages companies’ core business operations and expansion projects.
  • Handle recruiting and staffing positions for clients or candidates in the healthcare industry
  • Develop and maintain the research database of the company.
  • Marketing and Sales of company services to clients and candidates.
  • Maintain and negotiate contract agreements.
  • Handle public relations of the company’s image to the private and public sectors.

Confidential, Bridgewater, NJ

FEDERAL SPECIALIST

Responsibilities:

  • Perform stringent reporting and compliance requirements for the Federal supply Schedule processing chargeback claims and Public Health Service Contract.
  • Contract review of government FARs and DFARs.
  • Responsible for the negotiation of the Confidential contract, budget building development ensuring compliance with the Confidential and Confidential contracts, analyzing terms & conditions, and ensuring that the Government Pricing Calculating System is updated with accurate information, particularly as business or legal requirements change using the I-Many CARS system.
  • Contributes to the development and implementation of internal training programs as well as establishing, improving and updating policies and procedures to minimize financial risk and maximize compliance to federal regulations and SOX requirements.

Confidential, West Point, PA

CUSTOMER CONTRACT ANALYST

Responsibilities:

  • Responsible for maintaining and negotiating prices for the federal sector that produces annual gross sales of $1.5 billion per year with a net profit after rebates of $600 million per year.
  • Responsible for data collection, budget building analysis and business analysis, customer contract and program coordination in support of special pricing programs
  • Responsible for the development and implementation of data, systems and processes to evaluate analyze and report program performance for government and commercial pricing products.
  • Responsible for planning and executing appropriate research activities required providing needed data for recommendations on contract issues.
  • Review of government FARs and evaluation of DFARs as it relates to contracts.
  • Perform various data analysis for validation, customer programs, rebate calculation, and development of procedures to address business needs.

PROFESSIONAL SALES REPRESENTATIVE

Confidential, CHESTER, PA

Responsibilities:

  • Ranked number one cluster in the district with regard to Percent to Plan Objective.
  • District point person for Health Education expenditures; developed EXCEL spreadsheet to track each cluster s expenses by product.
  • Developed tactical launch plans for Maxalt & Zocor .
  • District point person for computer technical support.
  • District point person for the launch of Maxalt .
  • Conducted Health Education/Maxalt training sessions for Sales Representatives.
  • Performed monthly territory analysis and proposed action plans.

SITE COMPLIANCE AUDITOR

Confidential

Responsibilities:

  • Performed audits to include all facets of Biological Manufacturing, Sterile Operations, and staff areas to ensure compliance with compliance Good Manufacturing Practices and
  • European Compliance guidelines.
  • Maintained and updated the FDA/CBER Regulatory Commitment Database.
  • Investigated complaints against biological products. Performed regulatory product batch review of manufacturer process and SOP design in following FARs of product development.
  • Reviewed departmental standard operating procedures and master batch records.
  • Prepared and coordinated government inspections for review by government officials.
  • Performed orientation and training of new departmental employees.
  • Designed and monitored internal compliant system database for laboratory testing areas.

BIOCHEMICAL TESTING TECHNICIAN

Confidential

Responsibilities:

  • Administered a varying number of animal tests consisting of IN-VIVO toxicity, safety, and pyrogen tests.
  • Executed limulus amebycote lysate tests to detect bacterial endotoxins and serological identification.
  • Performed various departmental testing including, biochemical and nephelometric assaysand electrophoresis on clinical research materials.

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